Association for Research in Vision and Ophthalmology (ARVO) 2025
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Association for Research in Vision and Ophthalmology (ARVO) 2025


Content provided by Bausch + Lomb Medical Affairs.

Association for Research in Vision and Ophthalmology (ARVO) 2025


Content provided by Bausch + Lomb Medical Affairs.

Summary

The largest global meeting for vision science, spanning translational and clinical research. Bausch + Lomb had an extensive scientific presence with 6 oral presentations and 52 posters. Submitted publications highlighted results on surgical equipment (enVista Envy, Lux platform, Stellaris Elite®) as well as Bausch + Lomb's ocular surface portfolio with XIIDRA®, MIEBO®, LUMIFY®, AMD support (PreserVision AREDS3) and contact lenses (Bausch + Lomb INFUSE®).

Abstracts

PURPOSE: Semifluorinated alkanes (SFAs) are amphiphilic molecules with a fluorinated carbon segment (F) and a hydrocarbon segment (H) and have differing chain lengths and volatilities. These properties can influence the ability to form a long-lasting monolayer at air-liquid interfaces and inhibit evaporation. This in vitro study evaluated the impact of chain length on SFA evaporation rate (Revap) and inhibition of Revap of saline by assessing several SFAs including two dry eye drops, one consisting of 100% SFA (perfluorohexyloctane; F6H8; MIEBO) the other which includes the SFA perfluorobutylpentane (F4H5) as a vehicle (cyclosporine ophthalmic solution 0.1%; CsA 0.1%; VEVYE).

METHODS: Evaporation rates were measured gravimetrically at 35°C in a masked study. The following SFA containing dry eye drops and comparator SFAs were evaluated: F4H2, F4H5/CsA 0.1%, F6H7, F6H8 and F6H10. The Revap of 1 mL of each SFA and saline alone or saline with a 11 or 100 µL aliquot of SFA layered over the top was evaluated in a container with an exposed surface area similar to that of the human ocular surface. Total sample weight was recorded to five decimal places every 10 minutes over 100 minutes. The Revap for each sample was obtained from the slope of the best-fit line obtained by least squares linear regression analysis.

RESULTS: The mean (SEM) Revap in mg/min were 102 (25), 6.0 (0.6), 0.58 (0.20), 0.15 (0.017), and 0.12 (0.09) mg/min for F4H2, F4H5, F6H7, F6H8, and F6H10 alone, respectively (n=3-9). The Revap of saline alone was 10.53 (0.06) µm/min. Layering 100 µL F4H5/CsA 0.1% over saline had no effect on Revap (P=0.52) while F4H2, F6H7, F6H8, and F6H10 inhibited the Revap of saline by 8.4%, 16.7%, 73.9% and 60.7%, respectively (P<0.001 for all vs saline. none of the sfas had a significant inhibitory effect on revap of saline when applying a single 11 l drop except for f6h8 p><0.0001 vs saline n="10-25).">

CONCLUSIONS: The chain length and volatility of the SFAs appeared to impact their ability to inhibit the Revap of saline in this in vitro model. Shorter chain length SFAs F4H2 and F4H5/CsA 0.1% had minimal or no effect on Revap while longer chain length SFAs F6H8 and F6H10 had the maximal effect. The data reinforce the suitability of F6H8 as an anti-evaporative agent for the treatment of signs and symptoms of DED.

Early adoption and utilization of perfluorohexyloctane ophthalmic solution for dry eye disease
Shen Lee B, Pizzicato L, Divino V, Langford E, Shi L, Alexander A, Nair A, Nijm LM MIEBO® 

PURPOSE: Perfluorohexyloctane ophthalmic solution (PFHO), the first and only prescription eye drop for dry eye disease (DED) directly targeting tear evaporation, was introduced in the United States in September 2023. This claims database study describes clinical and demographic characteristics of PFHO early adopters and refill rates after initial prescriptions.

METHODS: Adult patients (≥18 years) newly initiating PFHO from September 1-November 30, 2023, were identified from the IQVIA Longitudinal Prescription Claims database. Eligible patients had linkage to the IQVIA Professional Fee Claims database and a 12-month pre-initiation period ("baseline") for sample characterization. Descriptive statistics were produced for demographics, index prescription characteristics, and baseline clinical characteristics including previous medication use and DED diagnosis. Refill rates within 60 days were assessed and descriptively compared to a cohort initiating cyclosporine ophthalmic solution 0.05% (CsA, branded or generic).

RESULTS: In total, 7209 patients (79.9% female; mean age, 60.6 years) initiated PFHO. PFHO prescribers were mostly optometrists (54.7%) and ophthalmologists (43.1%). Only 38.5% of patients had a claim indicative of DED in the baseline period. Common codes indicated aqueous deficient (28.7%), evaporative (11.3%), or inflammatory (16.7%) DED, reflecting its multifactorial nature. Almost half of patients (46.6%) used DED medication during baseline, suggesting potential dissatisfaction with prior therapy. CsA 0.05% (21.8%) and lifitegrast (17.1%) were most commonly used. The 60-day refill rate (among patients with a ≤30 days' supply of their index prescription and only one claim on index date) was 70.7% for PFHO versus 43.4% for CsA 0.05%.

CONCLUSIONS: DED appears under-recorded in the claims, as almost two-thirds of PFHO and CsA patients received the index prescription despite not having a recorded DED diagnosis. The higher refill rate for PFHO versus CsA 0.05% suggests a higher degree of patient satisfaction with this new, first-in-class treatment for DED.

PURPOSE: Lifitegrast ophthalmic solution, 5.0% (LIF) is an anti-inflammatory agent indicated for the treatment of signs and symptoms of dry eye disease. The purpose of this post-hoc analysis of Phase 3 pivotal data was to identify patients with rapid and pronounced reduction in dry eye symptoms with LIF treatment and identify defining characteristics.

METHODS: This is an exploratory analysis of data from the Phase 3 OPUS-2 and OPUS-3 studies (NCT01743729 NCT02284516), two 12-week, prospective, double-masked, multicenter, placebo-controlled, randomized, parallel-arm clinical trials. Pooled data in the LIF treatment arm were analyzed using a cluster analysis to identify homogenous populations of patient response types based on % change from baseline in eye dryness score (EDS; as evaluated on a VAS 0-100 scale) at Days 14, 42 and 84. Patients with Sjögren's syndrome or incomplete data were omitted from the analysis. Patient demographics and baseline characteristics amongst the defined subgroups were evaluated.

RESULTS: There were 1292 participants included in the OPUS-2/3 analysis set. The following 5 patient subgroups were identified in the LIF treatment arm from the cluster analysis: early sustained responders with ≥60% reduction in EDS at all timepoints (n=113; 17.7%); steady responders with ≥20%, ≥40% and ≥60% reduction in EDS at Days 14, 42, and 85 (n=113; 17.7%); Day 84 response of ≥60% (n=127; 19.9%); Day 84 response of ≤30% to <60% n="119;" 18.7 day 84 response of><30% n="166;" 26.0. there were significant differences in mean symptom scores across the five patient subgroups p><0.001), with numerically lower mean symptoms scores for pain burning stinging foreign body sensation and photophobia in the patients demonstrating an early sustained response.>

CONCLUSIONS: The majority of patients treated with LIF achieved ≥30% reduction in EDS by Day 84, with over half achieving a ≥60% reduction at this time point. The patient group with rapid and sustained EDS reductions by 2 weeks of treatment tended to have lower symptom scores than the rest of the subgroups, suggesting early treatment may be beneficial for maximal response. Further studies to corroborate these findings in other patient populations are warranted.

Impact of tilt and decentration on optical performance of monofocal and enhanced monofocal IOLs
Armengol J, Alba-Bueno F, Millan MS, Vega F, Azor JA enVista Aspire 

PURPOSE: To determine the robustness to tilt and decentration of several monofocal and enhanced monofocal intraocular lenses (IOLs). This study aims to assess how lens misalignments affect optical imaging performance, providing insight into the stability of visual outcomes.

METHODS: Optical bench testing complying with ANSI Z80.35-2018 was conducted using quasimonochromatic green light (550±5 nm) to evaluate the robustness of various monofocal (B+L enVista MX60E) and enhanced monofocal (B+L enVista Aspire and J&J Tecnis Eyhance) IOLs. The corneal spherical aberration was 0.27 μm for a 5.15 mm pupil at the IOL plane, and measurements were taken using a 3.0 mm aperture at the IOL plane. The modulation transfer function (MTF) and the area under the MTF (MTFa) between 0 and 50c/mm at zero defocus was assessed with IOLs aligned, tilted at 3.0° and 5.0° and decentered by 0.25 mm and 0.50 mm to estimate the impact on the image quality.

RESULTS: The MTF values in the case of a centered IOL show that Aspire has better performance than MX60E and Eyhance. All three lenses exhibited a similar reduction in MTFa when subjected to tilt (11 to 15% reduction for 5°). However, the MX60E demonstrated greater robustness to decentration than the other two lenses. The Aspire lens closely followed in performance, while the Eyhance lens was found to be the most sensitive to decentration. Tilt and decentration of IOLs are not typically measured in clinical evaluations, making designing lenses robust to physiological misalignment essential for stable optical performance.

CONCLUSIONS: The robustness of IOLs to physiological levels of tilt and decentration is an important factor in estimating their performance when implanted in the general population. Designing IOLs with improved tolerance to misalignment can help ensure consistent and reliable visual outcomes for patients. Both enVista IOLs demonstrated greater robustness to decentration compared to Eyhance, while the latter has a slightly better tolerance to tilt.

Optimization of E. coli for recovery of Acanthamoeba cysts
Domm W, Wheeler H, McGrath D, McCormick P Biotrue®  Hydration Plus Multi-Purpose Solution

PURPOSE:

Acanthamoeba trophozoites and cysts are ubiquitous throughout nature and known to cause serious corneal infections. To protect contact lens wearers, disinfection protocols require optimization for testing contact lens disinfecting solutions. E. coli (E.c) may be used as a food source to promote recovery of Acanthamoeba organisms after disinfection. Here, the concentration of E.c was optimized to promote optimal recovery of Acanthamoeba cysts following disinfection protocols.

METHODS:

Acanthamoeba castellanii (A.c, ATCC 50370) or Acanthamoeba polyphaga (A.p, ATCC 30461) trophozoites were cultured and seeded onto Non-Nutrient Agar (NNA) plates at 26-30oC. Organisms were harvested and subject to 30 minutes of disinfection by a non-ophthalmic 3% hydrogen peroxide solution. Controls and test samples were serially diluted in 96-well microtitre plates. Three independent E.c (ATCC 8739) cultures were grown overnight and diluted in ¼ Strength Ringers Solution to 100%, 50.0%, 33.3%, 25.0%, 12.5%, and 10.0%, used for recovery procedures and quantified. 50 ul of diluted E.c was added to each well, incubated for 14 days at 26-30oC, and inspected microscopically for recovery. Acanthamoeba recovery values were determined using the Spearman-Karber method and Log10 Reduction (LR) values were calculated.

RESULTS:

Recovery of A.c and A.p trophozoite inoculum controls or after injury were not affected by the E.c concentrations tested with recovery and LR insignificantly different between 100% to 10% E.c dilutions (p>0.05). Recovery of A.c cyst inoculum controls were not significantly different (p>0.05) within the E.c dilutions tested however recovery of A.c after injury were significantly decreased at low E.c concentrations (p<0.05) leading to a significantly elevated lr calculation at e.c dilutions lower than 33.3 25.0 p><0.05, 12.5 p><0.01, 10 p><0.01). a.p cyst inoculum control recovery was significantly lower at e.c dilutions below 25.0 p><0.05) while recovery of a.p cysts after injury were not significantly different p>0.05) leading to significantly lower LR values at E.c dilutions lower than 25.0% (12.5% p<0.05, 10 p><0.01).>

CONCLUSION:

Optimal recovery of Acanthamoeba cysts in disinfection procedures requires the induction of excystment followed by exponential growth. This data supports the use of E.c at concentrations greater than a 33.3% dilution for efficient recovery of Acanthamoeba cysts.

PURPOSE: Brimonidine tartrate ophthalmic solution 0.025% (BTOS) is indicated for the short-term relief of redness of the eye due to minor eye irritations. Although BTOS is available over-the-counter (OTC) in the US, physicians may choose to prescribe the product. This study sought to understand more about BTOS prescriptions by reviewing medical and pharmacy claims databases.

METHODS: The IQVIA Longitudinal Prescription Claims, Medical Claims, and Market Access Library data were used to analyze the demographics, baseline clinical characteristics, treatment patterns, and treatment costs of patients using BTOS.

RESULTS: For the full year periods 2020–2023, data were available for 8,611 patients. The majority of patients were aged 18–74 years and included more females (58%) than males (42%). Insurance/payer types were 51.8% cash, 41.1% commercial with the remainder Medicaid, Medicare or unknown. While most prescriptions were from ophthalmologists (54.6%) and optometrists (39.5%), a broad range of health professionals including family medicine doctors, nurse practitioners, anesthetists/nurse anesthetists, and physician assistants also prescribed BTOS. Ophthalmic conditions recorded in ≥30% of patients included 'disorders of eyelid, lacrimal system and orbit' (44.1%), 'disorder of lens' (40.3%), 'disorders of conjunctiva' (36.5%), 'glaucoma' (35.9%), and 'disorders of ocular muscles, binocular movement, accommodation and refraction' (33.2%). 38.7% of patients were also taking ophthalmic corticosteroids, and 35.2% artificial tears; additional concomitant medications included anti-allergy medications, anti-infectives and anti-inflammatories. Analysis of reporting intervals demonstrates an average of 1.97 claims per patient, with an average of 74 days between fills. Time on therapy (time between index claim and date of last claim plus days of supply of last claim agent) averaged 51 days. A small proportion of patients (7%) remain on therapy for over 271 days.

CONCLUSIONS: A wide range of healthcare professionals choose to prescribe BTOS to their patients, with comorbidities and concomitant medications suggesting that ocular redness is often a secondary symptom and/or complaint. For most patients, BTOS use is short term; however, the data presented here are likely to underestimate actual use as they do not capture the potential switch to OTC BTOS by patients.

PURPOSE: Lifitegrast ophthalmic solution 5%, an LFA-1 antagonist, is indicated for treatment of dry eye disease (DED). This study assessed the mechanism of action of lifitegrast in a murine model of DED.

METHODS: DED was induced in 6-8-week-old mice by exposure to controlled environmental chamber and subcutaneous injections of scopolamine. Mice were treated with topical lifitegrast (or normal saline [NS]) TID. DED severity was assessed with corneal fluorescein score (CFS), and T cells were quantified by flow cytometry (FC) of corneal single-cell suspensions. In vitro T cell proliferation assay was performed using naïve T cells from draining lymph nodes (dLNs) and dendritic cells (DCs). Expression of chemokine receptors on dLNs T cells was assessed by RT-PCR and FC. In adoptive transfer experiments, T cells from DED mice treated with lifitegrast or NS were transferred to (1) NS-treated DED mice to assess limbal vascular sticking efficacy (adhesion) of CD4+ T cells (number of sticking/rolling cells) and (2) RAG knockout mice; DED severity and T cells (in corneas and dLNs) were assessed after 5 days.

RESULTS: CFS was significantly reduced and tear secretion was significantly improved after 15 days of lifitegrast versus NS treatment in DED mice (P<0.05). in vitro proliferation of t cells isolated from dlns was 50 lower in the presence of lifitegrast versus ns p><0.05), suggesting inhibition of t cell-dc synapse formation. compared with ns treatment lifitegrast treatment resulted in reduction of ifn-secreting cd4 t cells th1 in the dlns recruitment of t cells to the cornea and significant reductions in cxcr3 and ccr4 chemokine receptor expression by fc and cxcr3 mrna levels in dlns cd4 t cells p><0.05). the limbal vascular sticking efficacy of cd4 t cells was significantly decreased following adoptive transfer of cd4 t cells to ns-treated ded mice from lifitegrast-treated ded mice compared with transfer of cd4 t cells from ns-treated ded mice after 15 days. adoptively transferred cd4 t cells from lifitegrast-treated versus ns-treated ded mice to rag knockout mice resulted in significant reduction of cfs p><0.05) and 60 reduction in cd4 t cell recruitment into cornea with no change in recruitment in dlns.>

CONCLUSIONS: These results demonstrate that topical lifitegrast has an effect beyond the ocular surface, directly on dLNs, through inhibition of T cell-DC synapse formation.

PURPOSE: To evaluate vitreous flow rates of 25-Gauge (Ga) dual-action, 25,000 cuts per minute (cpm) vitrectomy probes at various vacuum settings and to provide recommendations on optimized vacuum settings for retina shaving.

METHODS: The Bausch + Lomb Bi-Blade+ (BB+) 25,000 cpm dual-action pneumatic cutter was compared to the Bi-Blade (BB) 15,000 cpm cutter. Vitreous flow rates were measured in pig eyes with an open-sky technique with 50 to 660 mmHg vacuum at their maximum cut rates. The eyes were weighed before and after each timed test to calculate flow rate. To analyze near-port flow behavior, particle imaging velocimetry (PIV) was conducted in water at atmospheric pressure with vacuums ranging from 0 to 50 mmHg. Flow dynamics were visualized using Kenalog markers and captured at 10,000 frames per second.

RESULTS: Vitreous flow increased with vacuum for both the BB and BB+ cutters. At 50 mmHg, the BB achieved flow rates of 0.2±0.05 g/min, compared to the BB+ at 0.3±0.02 g/min. At 660 mmHg, flow rates were 3.63±0.07 g/min for the BB and 4.35±0.05 g/min for the BB+, representing a 20% improvement at maximum vacuum. Across the entire vacuum range, the BB+ demonstrated an average flow rate increase of 25% over the BB. The BB+ achieved equivalent flow to the BB at 660 mmHg when operated at only 520 mmHg, reducing the required vacuum by 120 mmHg. PIV of the BB+ port showed localized flow dynamics near the port. At 0 mmHg vacuum, localized outward flow was observed due to blade motion, with velocities reaching 0.16 m/s. At 50 mmHg, no residual outflow was detected.

CONCLUSIONS: The 25 Ga, dual-action 25,000 cpm probes demonstrate superior vitreous aspiration efficiency compared to the 15,000 cpm probes, achieving comparable flow rates with lower vacuum settings. Dual action cutters can support stable retina shaving at low vacuums.

PURPOSE: High cut-rate, dual action cutters like the BiBlade+® have significantly increased the rate at which vitreous can be removed. This study compares the flow rates, traction, pulsatile flow, and the sphere of influence of the 7,500 cpm Bausch & Lomb single action (SA) pneumatic vitrector to the 25,000 cpm Bausch & Lomb BiBlade+® pneumatic vitrector.

METHODS: Porcine vitreous flow characterization was performed on the B&L SA and the Biblade+® pneumatic cutters. Vacuum levels for each cutter were chosen at flow-matched conditions. Excised porcine vitreous was placed into a cuvette and imaged at 10,000 fps. The vitreous endogenous biomarkers were tracked using particle image velocimetry techniques to produce vitreous traction distances and measure changes in the flow directionality near the port to calculate pulsatile flow. The 90th percentile of the traction data was used to calculate sphere of influence, which is the furthest distance at which the cutter can affect and pull the vitreous per single cycle. The pneumatic cutters were operated at their maximum cut rate; 7,500 CPM for the SA, and 25,000 CPM for the dual action.

RESULTS: Flow-matched conditions of 0.75 g/min were used with vacuum levels of 232 mmHg for the SA and 136 mmHg for the dual action cutter. These conditions showed the dual action cutter vitreous inflow was more consistent compared to the SA cutter with a 45.7% reduction in traction, 56.3% lower pulsatile motion, and 55.9% reduction in sphere of influence (all significant with p<0.05).>

CONCLUSIONS: The dual action BiBlade+® pneumatic vitrector generated less traction, exhibited less pulsatile flow, and had a smaller sphere of influence during vitreous removal at the same flow rate as compared to single action cutters. These results suggest that the BiBlade+®'s better flow stability, more localized action, and better predictability, may be advantageous in reducing adverse events during vitrectomies.

PURPOSE: Perfluorohexyloctane ophthalmic solution (PFHO) is indicated for the treatment of signs and symptoms of dry eye disease (DED). In randomized controlled trials, significant reductions in signs and symptoms of DED were observed beginning at day 15 (the first postbaseline assessment) for PFHO compared with a hypotonic saline control. This prospective, multicenter, open-label, phase 4 study evaluated patient perceptions and satisfaction during the first 14 days of treatment with PFHO.

METHODS: This study enrolled adults with a history of DED for ≥6 months and clinical signs of Meibomian gland dysfunction. PFHO was instilled in both eyes QID for 14 days. Patients completed early outcome surveys during 4 clinic visits: day 1 (pretreatment [baseline]; 5 and 60 minutes post-PFHO instillation) and days 3, 7, and 14. DED symptom severity (overall and each of 8 individual symptoms) and treatment satisfaction were rated on a visual analog scale (range, 0-100). The primary endpoint was mean change from baseline in overall DED symptom severity at day 7.

RESULTS: Ninety-nine patients were enrolled (mean age, 61.3 years; 85.9% females). Mean (SD) VAS score for overall DED symptom severity was 72.1 (17.0) at baseline and decreased to 38.5 (22.8) at 5 minutes post-instillation, 31.7 (22.1) at 60 minutes post-instillation, 33.2 (25.1) at day 3, 27.8 (22.3) at day 7 (primary endpoint), and 24.7 (23.0) at day 14. Reduction in overall symptom severity was statistically significant at all postbaseline timepoints, including the Day 7 primary endpoint (mean change from baseline: -44.5 [61.7% reduction]; P<0.0001). significant reductions in severity were also observed for all 8 symptoms eye dryness burning stinging eye itching light sensitivity eye pain eye tiredness eye irritation and blurred vision at all postbaseline assessments p><0.0001). median ratings of treatment satisfaction were 83.0 at day 3 86.0 at day 7 and 90.0 at day 14.>

CONCLUSIONS: Early in the course of treatment with PFHO, patients with DED experienced significant reductions in dry eye symptom severity. Treatment satisfaction with PFHO was high.

Evaluation of a novel preservative‑free brimonidine tartrate formulation for conjunctival hyperemia
McGee S, DiVito M, Koetting C LUMIFY®  Preservative Free Redness Reliever Eye Drops

PURPOSE: Low-dose (0.025%) brimonidine tartrate ophthalmic solution (BTOS) is approved for the treatment of conjunctival hyperemia. As frequent exposure of the ocular surface to the preservative benzalkonium chloride can induce or exacerbate existing ocular irritation, a preservative-free formulation, BTOS-PF, has been developed. This study evaluated the efficacy and safety of BTOS-PF vs BTOS.

METHODS: This was a multicenter, double-masked, randomized, active-controlled, parallel-group study in healthy adults (>18 years) with ocular redness, conducted at six sites in the US. The study occurred over 5 weeks. After an initial in-office dose, both agents were self-administered 4 times daily ~4 hours apart for a duration of 4 weeks. The primary efficacy endpoint was ocular redness score as evaluated by the investigator prior to and at 5(+1), 15(+1), 30(+1), 60(+10), 90(+10), 120(+15), 180(+15), and 240(+15) minutes after investigational drug instillation (0–4-unit scale, allowing half-unit increments). Safety variables included physical exam including vital signs, adverse events (reported, elicited, and observed), best-corrected visual acuity at distance, slit lamp biomicroscopy, intraocular pressure, dilated ophthalmoscopy, and ocular rebound.

RESULTS: 380 participants were randomized 1:1. Baseline (pre-instillation) ocular redness values were comparable between the BTOS-PF and BTOS groups. All post-instillation redness values observed at all timepoints were also comparable between treatment arms, with mean differences between treatment groups ranging from -0.09 to 0.01 units, with upper confidence limits at all timepoints falling within the pre-determined limit for non-inferiority of 0.22 units. A total of 48 treatment-emergent adverse events were reported by 37/188 (19.7%) subjects in the BTOS-PF group and 61 treatment-emergent adverse events reported by 39/190 (20.5%) subjects in the BTOS group. The majority were mild. Tolerability, as measured by drop comfort assessment and questionnaire, was comparable between groups.

CONCLUSIONS: The primary endpoint was met with the novel BTOS-PF demonstrating statistical non-inferiority to BTOS in the reduction of ocular redness at all timepoints from 5 minutes to 240 minutes post-instillation. Overall, the safety profile of BTOS-PF was favorable and similar to BTOS.

Robustness to tilt and decentration of full range of vision intraocular lenses
Millan MS, Vega F, Azor JA, Armengol J, Alba-Bueno F Lux 

PURPOSE: To compare the misalignment tolerance of Full Range of Vision (FRoV) intraocular lenses (IOLs).

METHODS: Optical bench testing evaluated the robustness to tilt and decentration of four FRoV IOLs: a new refractive Bausch & Lomb LuxLife and three diffractive (ALCON PanOptix, BVI FineVision, J&J Tecnis Synergy). The eye model used 550 nm light and a lens representative of a healthy cornea with 0.27 μm spherical aberration for 5.15 mm IOL pupil. Modulation Transfer Function (MTF) and area under the MTF from 0 to 50 cpmm (MTFa) were assessed for far vision with a 3.0 mm pupil in aligned, tilted (3°, 5°), and decentered (0.25, 0.50 mm) conditions.

RESULTS: LuxLife IOL exhibited superior MTF performance in aligned conditions and greater tolerance to decentration compared to other IOLs. LuxLife, PanOptix, and Synergy IOLs showed similar tolerance to tilt, outperforming FineVision.

CONCLUSIONS: LuxLife IOL demonstrated better robustness to misalignment, essential for real-world performance. While on-bench results indicate little impact on MTFa, further clinical studies are needed to correlate these findings with visual acuity and contrast sensitivity. Although study provides valuable insights, limitations include the use of monochromatic light, a single corneal aberration value, and a 3mm IOL pupil.

Comparative analysis of the osmoprotective effects of over‑the‑counter dry eye formulations on human corneal epithelial cells
Millard K, VanDerMeid K, Marlowe Z, Coffey M, Koetting C, Quint J Blink®  Triple Care Preservative Free

PURPOSE: Dry eye is a disorder of the ocular surface due to tear deficiency, excessive tear evaporation, or irregular composition of tears. For most patients with mild dry eye symptoms, over-the-counter (OTC) dry eye drops are the first line of therapy. Blink Nourish (BN) is a novel, preservative-free lubricating eye drop containing glycerin, sodium hyaluronate, electrolytes, vitamin B12, and stabilized vitamin C, along with three amino acids and trehalose. In this study, BN was evaluated against other top-selling OTC lubricating eye drops to understand the biological effects on human corneal epithelial cells (HCECs).

METHODS: Transformed HCECs were maintained in EpiLife medium supplemented with human corneal growth supplement at 37°C, 5% CO2, and 95% relative humidity. HCECs were then exposed to 75% EpiLife medium with either 25% Hanks' Balanced Salt Solution (HBSS) as a control or 25% of each of five OTC dry eye products (including BN) for 24 hours, with each test formulation adjusted with NaCl to 400 or 450 mOsm/kg. Upon completion, the cell culture supernatants were collected and analyzed for release of cytokines interleukin (IL)-6 and tumor necrosis factor-α and chemokine IL-8, and cell metabolic activity was determined by the alamarBlue assay.

RESULTS: Metabolic activity was significantly higher than HBSS control with BN (p<0.05) at both 400 and 450 mosm kg. in contrast metabolic activity was significantly lower than control for three of the four comparator drops and no significant difference for the fourth comparator. furthermore bn was associated with significantly lower mean cytokine responses versus the hbss control. all comparator eye drops were associated with significant increases in il-6 at both 400 and 450 mosm kg. in the il-8 assessment hbss control was associated with a large increase at 450 mosm kg which was not seen with bn and one of the four comparator drops.>

CONCLUSIONS: These results demonstrate the osmoprotective effects of BN in vitro. The combination of added nutrients and amino acids within the novel BN formulation has the potential to contribute to maintaining homeostasis of the ocular surface environment and improve symptoms of dry eye.

PURPOSE: Glaucoma is a group of neurodegenerative eye diseases that lead to progressive vision loss. Management of glaucoma focuses on decreasing intraocular pressure (IOP) with the most common treatment consisting of topical ocular hypotensive medications. Latanoprostene Bunod 0.024% (LBN) is a topical ocular hypotensive prostaglandin (PGA) indicated for the reduction of IOP in open-angle glaucoma (OAG) or ocular hypertension (OHT). The study quantifies changes in intraocular pressure in patients after switching to LBN from prior pharmacotherapy

METHODS: Adult patients (=18 years) with a diagnosis of OAG/OHT and =1 LBN prescription were identified in the American Academy of Ophthalmology IRIS© Registry (Intelligent Research in Sight) linked to Komodo HealthMap claims. Study period was from July 2017 - June 2023. Index date was the date of first prescription of LBN. The IOP at baseline and after treatment switch to LBN was compared at two follow-up visits, (1) at any time between day 30 and day 180 post-LBN claim, (2) in a subset of patients at any time between day 90 and day 180 post-LBN. Statistical significance was set at p<0.05>

RESULTS: 833 patients with OAG/OHT met the study selection criteria that switched to LBN from prior pharmacotherapy. The mean (SD) reduction in IOP at first follow-up was 2.8 (4.7) mmHg after switching to LBN. A vast majority (55.3%) of patients switched from PGA monotherapy to LBN monotherapy with a mean (SD) IOP reduction of 2.4 (3.7) mmHg and 15.5% patients switched from non-PGA combination to LBN with a mean (SD) IOP reduction of 3.3 (6.1) mmHg. Of the 833 patients, 137 patients were followed up for a second IOP measurement with a mean (SD) reduction in IOP of 3.6 (5.2) mmHg compared to baseline. Of these patients, 53.2% switched from PGA monotherapy to LBN with a mean (SD) IOP reduction of 3.1 (4.2) mmHg. IOP reductions were statistically significant

CONCLUSIONS: Switching treatment from current mono- or combination pharmacotherapy to LBN in patients with OAG/OHT shows greater than 2-mmHg reduction in IOP in majority of the patients supporting the effectiveness of LBN. Reducing IOP, a modifiable risk factor can reduce the risk of visual field loss. These large-scale real-world study findings are consistent with those observed in smaller observational studies and clinical trials, confirming LBN effectiveness in real-world clinical practice

Multi‑purpose contact lens solution assessment among hydrogen peroxide lens care users with dryness
Nguyen C, Schaeffer M, Reindel W, Rah MJ, Shahidi A, Schafer J Biotrue®  Hydration Plus Multi-Purpose Solution

PURPOSE:

Eye care practitioners may recommend a “preservative-free” hydrogen peroxide lens care solution (HPS) to help address concerns of contact lens (CL) discomfort and/or lens care compliance with use of a multi-purpose solution (MPS). A unique MPS (Biotrue Hydration Plus) based on learnings from the Tear Film & Ocular Surface Society International Dry Eye Workshop II (TFOS DEWS II) reports, contains the moisturizer hyaluronan, surfactants poloxamine 1107 and poloxamer 181, an electrolyte (potassium), and an osmoprotectant/antioxidant (erythritol), was developed to improve comfort among CL users. Here we describe results of a real-world in-home use test study that evaluated performance of this MPS among prior branded HPS (Clear Care) users who self-reported CL-related dryness.

METHODS:

CL users were recruited online via consumer panel providers. To be eligible, participants had to be at least 18 years of age, be a habitual user of soft CLs, and have had an eye exam within 2 years. Qualifying participants were to use the MPS for 7 days with a new pair of CLs before completing an online survey (7-point Likert scale) on product performance. A two-sided exact binomial test assessed whether agreement was 06/12/2024, 15:17 indicated for more than 50% of responses for performance attributes.

RESULTS:

A total of 120 participants who habitually used these HPS solutions and self-reported CL-related dryness enrolled. The population was 65.8% female with a mean (SD) age of 42.4 (10.6) years. The majority (60.0%) had been wearing CLs for over a decade. At the end of the trial period, overall satisfaction with the MPS was 98.3%. Agreement rates were 98.3% for “is gentle on my eyes”, 95.0% for “keeps my lenses feeling clean”, 94.2% for “helps prevent CL dryness”, 97.5% for “my lenses are comfortable from the moment I put them in”, 93.3% for “helps keep my contacts comfortable so I do not feel like my eyes are tired”, 95.8% for “helps my lenses stay comfortable throughout the day”, 92.5% for “helps my lenses stay hydrated throughout the day”, and 94.2% for “helps my lenses stay comfortable even at the end of the day”. Agreement responses were statistically significantly greater than 50% for all performance attributes (p<0.05).>

CONCLUSION:

This unique MPS contributes to a positive CL wearing experience even in a population of prior HPS users with self-reported CL-related dryness.

Comparative analysis of phacoemulsification efficiency: insights into two system designs
Papour A, Higgins G Stellaris Anterior Segment Surgery(3)

PURPOSE: Cataract surgery is the most performed surgical procedure worldwide, exceeding 10 million cases annually. Despite its prevalence, phacoemulsification technology lacks standardization, making direct comparisons of clinical outcomes and machine settings challenging. This study aims to evaluate the fragmentation efficiency of two phacoemulsification systems under controlled conditions. We sought to provide surgeons with data-driven insights into surgical settings and advancing the standardization of phacoemulsification systems.

METHODS: Pig lenses were excised and hardened by immersion in 80°C water for 2 minutes. Fragmentation tests compared the Stellaris Elite (Bausch & Lomb) using a 1.8 MICS needle (28.5 kHz, up to 150 µm stroke) and the Centurion (Alcon) with the Ozil handpiece and Balanced Tip (44.5 kHz, up to 90 µm stroke, longitudinal; 32 kHz, torsional). Each machine operated on a single lens location with an 80 ms pulse under a constant 450 mmHg vacuum, submerged in water. Tests were conducted at 10%, 20%, 40%, and 80% power, with three repetitions per condition. Fragmentation depth was measured via OCT, calculated per cycle, and normalized. Cumulative Dissipated Energy (CDE) was recorded for the Centurion and calculated for the Stellaris Elite based on ultrasonic energy principles.

RESULTS: The Stellaris Elite system demonstrated significantly higher fragmentation efficiency compared to the Centurion across all tested power levels in longitudinal mode. At 10%, 20%, 40%, and 80% power, the Stellaris Elite achieved fragmentation efficiency improvements of 5x, 1.85x, 2.2x, and 1.54x, respectively, with an average increase of 2.65x. Additionally, the calculated CDE was lower with reductions of 1.09x, 1.7x, 2.4x, and 3.3x at 10%, 20%, 40%, and 80% power, averaging a 2.1x reduction overall. When compared to the Centurion torsional mode, the Stellaris Elite longitudinal mode achieved an average of 5.26x greater efficiency, along with a 1.4x average reduction in CDE (all with p<0.05).>

CONCLUSIONS: Prioritizing lower ultrasonic frequencies and longer stroke lengths significantly enhanced fragmentation efficiency and reduced CDE in hardened pig lens tests. These findings highlight the importance of frequency and stroke as critical variables for advancing and standardizing phacoemulsification technology.

Intervening in the dry eye inflammatory cycle with a daily oral nutritional supplement
Periman LM, Ryan R, Gioia N, Poteet J Blink  NutriTears® 

PURPOSE: If left unchecked, the chronic inflammation of dry eye drives ocular surface change and accumulating damage, which can lead to increased symptomology, irritation, and worsening tear dysfunction. NutriTears® (NT) is an oral supplement containing a unique combination of lutein and zeaxanthin isomers, curcuminoids, and vitamin D3. In a study evaluating the efficacy and safety of NT in participants with dry eye syndrome, the effect of NT on the presence of matrix metalloproteinase-9 (MMP-9) in tears was assessed.

METHODS: This randomized, double-blind, placebo (PBO)-controlled study was conducted at four study centers in the US. The study involved five visits with follow-up out to Day 56 (± 3 days). Participants consumed one soft gel capsule per day with their breakfast meal. The presence of MMP-9 was assessed using InflammaDry® MMP-9 test kits (QUIDEL®; San Diego, CA, USA).

RESULTS: 155 participants were randomized, of which 116 (NT, n=57; PBO, n=59) completed the study. The presence of MMP-9 in the right and left eyes was significantly different between groups at Day 56 (both values p<0.001) as the number of positive tests in the nt group decreased right eye: day 0="46," day 56="15," -67.39 left eye: day 0="44," day 56="17," -61.36 whereas positive tests did not decrease in the pbo group right eye: day 0="45," day 56="48," 6.67 left eye: day 0="46," day 56="50;" 8.70. moreover corneal staining and conjunctival staining were significantly improved in the nt versus pbo groups at day 56. one subject from each group reported 1 adverse event during the study but no serious adverse events were reported in either group.>

CONCLUSIONS: The administration of one NT soft gel capsule per day for 8 weeks was associated with evidence of significant improvements in inflammation, as assessed by corneal and conjunctival staining and presence of MMP-9 at Day 56. Taken together with published data on improved tear quantity and quality, these findings suggest NT is associated with improvement in inflammatory processes that drive the pathophysiology of dry eye syndrome.

PURPOSE: Artificial tears remain the most common treatment for the symptoms of dry eye. In a clinical study of a novel lipid-containing eye drop (BTC) versus an existing non-lipid eye drop (NLED), the novel agent provided a significant improvement in overall comfort and demonstrated non-inferiority to comparator drops. Here we present additional patient-reported outcomes and safety assessments.

METHODS: This was a prospective, double-masked, multicenter study that enrolled subjects who self-reported symptoms of ocular dryness in the prior 3 months and/or were habitual users of tear supplements. Participants were evaluated for dry eye symptoms and signs at Visit 1 (baseline), Visit 2 (Day 7±1), and Visit 3 (Day 30±2). The primary hypothesis of the study was that BTC is non-inferior to NLED with respect to change in ocular comfort from baseline at 30-day follow-up. Additional assessments included quality of vision, ocular symptoms, and corneal staining.

RESULTS: The change in overall vision quality was statistically significantly greater in the BTC group versus the NLED group at both Day 7 (least squares mean difference [95% confidence interval (CI)] 8.0 [0.7, 15.4]) and Day 30 (9.3 [1.7, 17.0]); however, overall scores were numerically similar between groups at all timepoints. The proportion of eyes with reported ocular symptoms was not statistically significantly different between groups at Day 7 (odds ratio [OR; 95% CI] 0.967 [0.528, 1.770]) or Day 30 (OR [95% CI] 1.160 [0.610, 2.203]). At baseline, moderate-to-severe eye dryness was reported by 46/154 (29.9%) of participants in the BTC group and 56/162 (34.6%) of participants in the NLED group. By 30-day follow-up, this decreased to four participants (2.6%) in the BTC group and six (3.8%) in the NLED group. The proportion of subjects with Grade ≥2 corneal staining was not statistically significantly different between study groups (OR [95% CI] 1.601 [0.178, 19.616], p=0.6757). There were no cases of Grade ≥3 corneal staining or any other biomicroscopy findings, and no corneal infiltrates observed during the study.

CONCLUSIONS: While this study did not select or group participants by dry eye category, it may be hypothesized that patients with lipid-deficient dry eye/meibomian gland dysfunction might benefit from the addition of a lipid component to the artificial tear formulation without compromising quality of vision.

Real‑world assessment of a multi‑purpose contact lens solution in contact‑lens‑related dryness
Reindel W, Nguyen C, Schaeffer M, Rah MJ, Shahidi A, Schafer J Biotrue®  Hydration Plus Multi-Purpose Solution

PURPOSE:

While dryness is the most common problem experienced by contact lens (CL) wearers, the biggest influencer on overall satisfaction with a multi-purpose solution (MPS) is all-day comfort. Lens care manufacturers continue to explore ingredients to reduce dryness and improve comfort. A unique MPS deriving learnings from the Tear Film & Ocular Surface Society International Dry Eye Workshop II (TFOS DEWS II) reports, including the moisturizer hyaluronan, surfactants poloxamine 1107 and poloxamer 181, an electrolyte (potassium), and an osmoprotectant/antioxidant (erythritol) was developed to improve comfort. This real-world in-home use test assessed the performance of the MPS (Biotrue Hydration Plus) among users who self-reported experiencing CL-related dryness.

METHODS:

Participants were recruited online through consumer panel providers. Eligibility criteria required individuals to be at least 18 years old, be regular users of soft CLs, and to have undergone an eye exam within the past 2 years. Eligible participants who reported experiencing CL dryness prior to the trial were instructed to use the Biotrue Hydration Plus MPS for 7 days with a new pair of CLs. After this period, they completed an 06/12/2024, 14:35 online survey, using a 7-point Likert scale, to evaluate performance for the MPS. A two-sided exact binomial test assessed whether agreement was indicated for more than 50% of responses for performance attributes.

RESULTS:

For the 288 subjects with self-reported CL dryness in this study, the mean (SD) age was 42.0 (12.3) years. With their habitual CL and lens care products, 52.1% self-reported blurry/fluctuating vision, 76.0% tired eyes, and 56.9% eye strain. After the trial period, 95.5% of participants agreed the new MPS helps their CLs stay comfortable throughout the day, 96.9% agreed the MPS keeps CLs feeling clean, 94.4% agreed the MPS keeps CLs comfortable so they do not feel their eyes are tired, and 93.8% agreed the MPS helps prevent CL dryness. Overall satisfaction was 99.7%. Agreement responses were statistically significantly greater than 50% for all performance attributes (p<0.05).>

CONCLUSION:

This MPS containing the moisturizer hyaluronan, poloxamine 1107 and poloxamer 181, an electrolyte (potassium), and an osmoprotectant/antioxidant (erythritol) contributes to a positive CL wearing experience among users with self-reported CL-related dryness.

PURPOSE:

Recent studies have demonstrated that oxidative stress is involved in the pathogenesis of dry eye disease. Polyols erythritol and glycerin have demonstrated osmoprotective properties in vitro. Evidence indicates these polyols also have antioxidant properties. The purpose of this study was to initiate oxidation in Riken human corneal epithelial cells (R-HCECs) with hydrogen peroxide and evaluate the antioxidant properties of these polyols individually. In addition, a packaging formulation containing these polyols was evaluated in this assay.

METHODS:

R-HCECs were pre-exposed to CellROX Green (CRG) for 30 minutes and then received 0.003– 0.1% hydrogen peroxide (H2O2) to determine an effective concentration needed to initiate CRG oxidation. For antioxidant testing, R-HCECs were preincubated in medium containing a final concentration of 0.9% erythritol and 0.9% glycerin or the packaging formulation containing this concentration of the polyols for 30 minutes. CRG was added with the test articles for 30 minutes and cells were then exposed to 0.006% H2O2 for 3 hours. Fluorescence from oxidized CRG was measured, and integrated responses of the change in relative fluorescent units were analyzed by calculating the area under the curve for each test well over the time course. Cells were assessed for metabolic activity by alamarBlue after completion of the antioxidant assay. 06/12/2024, 16:27

RESULTS:

Exposure of R-HCECs to H2O2 significantly affected cellular metabolic activity, and fluorescence indicated that 0.006% H2O2 was sufficient to initiate significant oxidation of CRG. Cells receiving the test articles and hydrogen peroxide had significantly higher metabolic activity and significantly reduced oxidation of CRG compared with cells receiving 0.006% H2O2.

CONCLUSION:

This in vitro cell model can be used to initiate oxidative stress in R-HCECs and evaluate the antioxidant potential of ingredients in eye care formulations. Both 0.9% erythritol and 0.9% glycerin in combination or the packaging formulation with these polyols exhibit antioxidant activity with human corneal epithelial cells.

PURPOSE: To investigate various methods for estimating visual acuity based on simulated Modulation Transfer Function (MTF) data in patients implanted with a monofocal intraocular lens (IOL).

METHODS: The clinical visual acuity from two distinct studies involving patients implanted with the enVista MX60E IOL was correlated with the normalized area under the curve (AUC) of the simulated MTF. Simulations were conducted using Zemax with a modified Liou-Brennan eye model using white light, incorporating a 20D IOL and a 3.0mm pupil. The AUC was normalized to the diffraction limit, with calculations performed across two frequency ranges: 0–50c/mm (AUC50) and 0–100c/mm (AUC100). Linear, logarithmic, exponential, logistic, and rational fitting models were applied to assess correlations.

RESULTS: In terms of R², the logistic, exponential, power law, and rational models yielded very similar results, all superior to the linear and logarithmic correlations. For these models, both AUC50 and AUC100 performed very similar while AUC50 showed slightly superior results for the linear and logarithmic correlations. Poorer visual acuities were more difficult to predict due to the higher standard deviations of the clinical studies.

CONCLUSION: Exponential correlation using the 0–100 c/mm frequency range appears to be the most cost-effective method for simulating expected visual acuity in patients implanted with IOLs.

PURPOSE: Perfluorohexyloctane ophthalmic solution (PFHO; MIEBO) is indicated for the treatment of signs and symptoms of dry eye disease (DED). This post hoc analysis assessed the efficacy of PFHO among patients with DED and cataract in the GOBI and MOJAVE pivotal studies.

METHODS: GOBI and MOJAVE were phase 3, randomized, hypotonic saline–controlled, 8-week clinical studies evaluating the efficacy and safety of PFHO dosed four times a day in participants ≥18 years with DED. Primary endpoints were change from baseline in total corneal fluorescein staining (tCFS) score (National Eye Institute scale, 0-15) and eye dryness visual analog scale (VAS) score (0-100). In this analysis, data for these endpoints were pooled and evaluated using an analysis of covariance among patients categorized into subgroups of patients with concomitant cataract and patients without cataract (or pseudophakia).

RESULTS: Of 1217 patients overall (n=614 PFHO; n=603 saline), there were 411 patients with cataract and 667 without cataract. Consistent with overall population, reductions (ie, improvements) in tCFS and eye dryness scores were significantly greater for PFHO compared with the control treatment in both subgroups. At Week 8, least-squares (LS) mean change from baseline in tCFS score for PFHO vs control group was 1.9 vs 0.9 (P=0.0003) for patients with cataract and 2.5 vs 1.3 (P<0.0001) for patients without cataract. for eye dryness vas score ls mean change from baseline in pfho vs control group was 28.0 vs 19.3 p="0.0015)" for patients with cataract and 29.3 vs 19.4 p><0.0001) for patients without cataract. improvements in tcfs and eye dryness scores were also observed at week 2: ls mean change in pfho vs control group was -1.4 vs -0.9 p="0.03)" in patients with cataract and -2.0 vs -1.4 p="0.0004)" in patients without cataract for tcfs and -18.6 vs -15.3 p="0.14)" and -18.6 vs -10.0 p><0.0001), respectively for eye dryness.>

CONCLUSIONS: PFHO was effective in improving signs and symptoms of DED in patients with DED and concomitant cataract. These data support that PFHO may be a promising treatment option for preoperative management of patients with DED undergoing cataract surgery, warranting further study in this patient population.

Comparative analysis of the antioxidant effects of a novel over‑the‑counter dry eye drop on human corneal epithelial cells
VanDerMeid K, Marlowe Z, Millard K, Coffey M Blink®  Triple Care Preservative Free

PURPOSE: Recent studies have demonstrated that oxidative stress is involved in pathogenesis of dry eye disease. Raised levels of reactive oxygen species, lipid oxidative stress markers, and inflammatory cells were found in the conjunctiva and tear film of patients with Sjögren syndrome and dry eye animal and cell models. For most patients with mild dry eye symptoms, over-the-counter dry eye drops (OTC-DED) are the first line of therapy. OTC-DED can help maintain ocular surface homeostasis by reducing oxidative stress. The purpose of this in vitro study was to examine the antioxidant effects of a novel OTC-DED, Blink Nourish (BN), and two other common OTC-DEDs on human corneal epithelial cells (HCECs).

METHODS: Riken-HCECs were pre-exposed to the OTC-DED for 30 minutes and then exposed to CellROX Green (CRG) Reagent for 30 minutes. CRG media were removed, and the cells were then exposed to 0.003% or 0.006% hydrogen peroxide (H2O2) and OTC-DED. Changes in oxidized CRG relative fluorescent units were measured every 15 minutes for 2 hours. Integrated responses of the change in relative fluorescent units were analyzed by calculating the areas under the curve (AUC) for each test well over the time course. Upon completion of the antioxidant experimental time course, cells were assessed for cellular metabolic activity using alamarBlue.

RESULTS: No significant differences were observed with cells exposed to 0.003% H2O2; however, cells exposed to 0.006% H2O2 had significantly lower metabolic activity versus the Hanks' Balanced Salt Solution control. Cells exposed to 0.003% H2O2 and 0.006% H2O2 had increased CRG fluorescence and AUC of fluorescence over time. BN and both BN and Refresh Relieva had significantly lower AUCs versus the cells exposed to 0.003% and 0.006% H2O2 controls, respectively. Systane Hydration and Biotrue Hydration Boost both had significantly higher AUCs versus the 0.003% H2O2 control.

CONCLUSIONS: These results indicate the antioxidant effects of BN with HCECs compared with common OTC-DED products in this in vitro cell model. The BN formulation exhibits antioxidant activity and demonstrates potential to maintain homeostasis of the ocular surface environment.

Assessment of halo caused by a new full‑range‑of‑vision intraocular lens
Vega F, Azor JA, Armengol J, Alba-Bueno F, Millan MS enVista Envy 

PURPOSE: To analyze in-vitro the features of the halo produced by a new Full Range of Vision (FRoV) intraocular lens (IOL) and compare it with two well-known designs.

METHODS: The halo formed in distance vision by the new FRoV IOL (enVista Envy, Bausch + Lomb) was imaged using a 3.44 arcmin pinhole test in an ISO model eye (ISO 11979-2:2014, model eye 2) with white light, per ANSI Z80.35-2018 guidelines. The setup simulates viewing a car headlight (20 cm) at 200 meters. The cornea's spherical aberration was +0.27 μm (5.15 mm pupil at the IOL plane). Halos from two established designs, AcrySof PanOptix (Alcon) and Tecnis Synergy (J&J), were assessed for comparison. Halo size and energy were measured with 20.0 D lenses using 3.0- and 4.5-mm apertures at the IOL plane.

RESULTS: The Envy IOL produces with both pupils a smooth halo whose size does not increase significatively with pupil (from 20.2±0.5 arcmin to 20.6±0.5 arcmin with 3.0- and 4.5 mm pupils, respectively) due to the apodised design of this lens. In stark contrast, the trifocal diffractive PanOptix IOL exhibits the largest halo size variation (from 20.9±0.5 arcmin to 30.5±0.5 arcmin with 3.0- and 4.5 mm pupils, respectively). Synergy forms a two-ring shape halo whose size has smaller dependence on the pupil size than PanOptix, but comparable to Envy (20.1±0.5 and 21.1±0.5 arcmin with 3.0- and 4.5 mm pupils, respectively). Regarding halo relative intensity, all three IOLs spoil comparable amounts of energy into the halo, representing over 50% of the total energy with the larger pupil. The effect of the apodization is evident with the Envy design, as it maintains a similar intensity profiles across both pupil sizes. Synergy IOL's behavior looks alike. In contrast, PanOptix spreads energy onto a larger halo with the large pupil compared to the small one.

CONCLUSIONS: The halo of the FRoV Envy IOL has been analyzed and compared to other two trifocal diffractive IOLs. Under light conditions emulating mesopic vision, the new FRoV IOL produces smaller and smoother halos than PanOptix and Synergy respectively. Clinical studies are necessary to further confirm this result.

Disinfection efficacy of a unique multi‑purpose solution against Acanthamoeba trophozoites
Wheeler H, Domm W, McGrath D, McCormick P Biotrue®  Hydration Plus Multi-Purpose Solution

PURPOSE:

Acanthamoeba keratitis (AK) is a devastating ocular infection that can lead to corneal damage and blindness. A. castellanii (A.c) and A. polyphaga (A.p) are keratitis-causing strains utilized in disinfection efficacy tests and understanding amoebicidal activity of contact lens multi-purpose solutions (MPS) against broader Acanthamoeba strains can provide added value. The purpose of this study was to evaluate the efficacy of a unique (Biotrue® Hydration Plus) and two comparator MPS against ocular strains of Acanthamoeba.

METHODS:

A.c (ATCC 50370, PRA-105, and 50498) or A.p (ATCC 30461, 50371, and 50495) trophozoites were prepared to challenge three MPSs: MPS-1 (0.00015% polyquarternium-1 [PQ-1], 0.0005% polyaminopropyl biguanide [PAPB], and 0.00025% alexidine dihydrochloride); MPS-2 (0.0006% myristamidopropyl dimethylamine and 0.001% PQ-1); MPS-3 (0.00016% alexidine dihydrochloride and 0.0003% PQ-1). Disinfection by MPS-1 was determined at 4 hours and MPS-2 and -3 at 6 hours after inoculation. Recovery of Acanthamoeba was performed by serially diluting in a 96-well microtitre plate, adding E. coli and incubating for 14 days at 26-30°C. Acanthamoeba recovery values were determined using the Spearman-Karber method and Mean Log₁₀ Reduction (MLR) values were calculated.

RESULTS:

All three MPS solutions showed strong disinfection efficacy against A.c ATCC 50370 trophozoites with MLR of MPS-1 3.9, MPS-2 3.9, and MPS-3 3.9 (p>0.05) and A.c ATCC 50498 trophozoites with a MLR of MPS-1 3.3, MPS-2 3.4, and MPS-3 3.4 (p>0.05). MPS-1 and -2 (MLR=3.6 for both) showed increased efficacy of A.c ATCC PRA-105 trophozoites when compared to MPS-3 (MLR=2.6, P<0.001). all three mps solutions showed strong disinfection efficacy against a.p atcc 30461 trophozoites with mlr of mps-1 3.8 mps-2 3.8 and mps-3 3.7 p>0.05), MLR of MPS-1 3.7, MPS-2 3.7, and MPS-3, 3.7 (p>0.05) for A.p ATCC 50371 trophozoites, and MLR of MPS-1 4.1, MPS-2 4.1, and MPS-3 4.1 (p>0.05) for A.p ATCC 50495 trophozoites.

CONCLUSION:

MPS-1 (Biotrue® Hydration Plus) showed significantly greater effectiveness against one ocular strain of Acanthamoeba trophozoites when compared to one marketed MPS and similar effectiveness compared to another marketed MPS for multiple additional strains. Overall, the robust amoebicidal efficacy of this MPS supports its use in the protection of contact lens-wearing patients from the risk of AK.

PURPOSE: Lifitegrast ophthalmic solution 5% is indicated for the treatment of signs and symptoms of dry eye disease (DED). This survey of eyecare providers aimed to examine real-world utilization and outcomes of lifitegrast in the treatment of patients with DED.

METHODS: Eyecare providers (ECPs: ophthalmologists and optometrists) treating patients with DED were invited to complete a provider survey. The survey included items regarding practice characteristics, lifitegrast utilization, satisfaction, and adverse events (AEs). Satisfaction with lifitegrast relative to other prescription eye drops was rated on a scale from 0 (very dissatisfied) to 10 (very satisfied). ECPs also provided case study data for up to five patients with DED who initiated lifitegrast treatment.

RESULTS: Twelve ECPs (6 MDs, 6 ODs) responded; they reported on a mean of 1288 (range, 35-6000) patients diagnosed with DED per year, of whom 21%, on average, received lifitegrast treatment. Seven ECPs provided 33 case reports. Overall, ECPs reported that DED severity was mild in 24.1%, moderate in 50.5%, and severe in 19.1% of patients to whom lifitegrast was prescribed. Lifitegrast was commonly prescribed to some patients with contact lens-related DED (91.7% of ECPs) and before or after refractive surgery (83.3% of ECPs) or cataract surgery (83.3% of ECPs). Two-thirds (67%) of ECPs reported near/complete symptom resolution in patients after 1 to 3 months of lifitegrast treatment. Satisfaction ratings (mean [range]) for onset and effectiveness were 6.8 (3-9) and 6.6 (3-9), respectively. Improvement was sustained during treatment up to 12 months, supported by case data (mean [range], 15 [1-69] months). AEs considered by the ECPs as related to lifitegrast use included blurred vision, burning/stinging, and dysgeusia; all AEs were mild or moderate in severity.

CONCLUSIONS: Findings from this real-world survey of ECPs highlight the rapid and durable response associated with lifitegrast for the treatment of patients with DED. AEs were consistent with the known safety profile of lifitegrast.

PURPOSE: Conjunctival hyperemia (CH) occurs through vasodilation reactions in the conjunctiva. Existing treatments, including ocular vasoconstrictors and antihistamines, provide temporary relief; however, continued use has been associated with tachyphylaxis and adverse events. This study explored healthcare professionals' (HCPs) experience treating CH and satisfaction with available treatments, including brimonidine tartrate (0.025%), an ophthalmic decongestant available over the counter in the United States and via prescription only in Europe.

METHODS: A semi-structured interview guide was developed based on a targeted literature review. Interviews were conducted with ophthalmologists in the US (n=4), Spain (n=4), Portugal (n=4), and France (n=4) who had experience treating CH with a range of treatments, including brimonidine tartrate (0.025%). Interview topics included CH pathology, treatment decisions, unmet needs, and treatment satisfaction. Interviews were recorded, transcribed verbatim, and analyzed using content analysis. This study received ethical review exemption from the WCG Institutional Review Board.

RESULTS: HCPs had 14–25 years' experience treating CH and treated 40–100 patients with CH in the prior month. HCPs reported limitations with existing treatments, such as eye sensitivity and rebound redness. Brimonidine tartrate (0.025%) was reported to be fast-acting and to cause fewer adverse events. HCPs emphasized the importance of determining and treating the cause of CH but noted brimonidine tartrate (0.025%) was a well-tolerated adjunctive option. In Europe, it was suggested that while prescription-only status reduces accessibility, it helps ensure HCPs monitor the cause of CH. Conversely, US HCPs stated that while over-the-counter availability increased accessibility, it was harder to monitor patient usage.

CONCLUSIONS: HCP experience of the current treatment landscape has previously been limited to treatments with short-term efficacy and adverse events. Brimonidine tartrate (0.025%) provides an effective and well-tolerated solution that addresses the aesthetic needs of patients with CH. HCPs highlight the need to identify and treat the underlying cause of CH, but report brimonidine tartrate (0.025%) can be used as an adjunctive treatment.

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