PURPOSE: The safety and efficacy of transepithelial photoreactive keratectomy (t-PRK) with or without end treatment laser polishing was compared with standard PRK in a prospective, randomized, controlled, single-blind, single-surgeon, single-center, post-market clinical study (NCT04698174).

METHODS: Thirty-five patients undergoing refractive surgery for correction of ametropia were bilaterally treated with conventional PRK in one eye and t-PRK in the other (16 with end-laser polishing and 19 without). Myopic and hyperopic patients were required to have a manifest refraction spherical equivalent (MRSE) of ≤−1.5D and ≥+1.5D, respectively. The primary endpoint was non-inferiority on absolute refractive predictability at 3 months post procedure, with a margin of 0.2D. Secondary endpoints included adverse events (AEs), MRSE, intraocular pressure (IOP), and monocular uncorrected and corrected distance visual acuity (UDVA/CDVA) at 6 months.

RESULTS: Mean baseline MRSE was −4.41D (PRK group) and −4.29D (t-PRK group). Mean ± standard deviation absolute refractive predictability at 3 months was 0.26±0.23 in the PRK group and 0.34±0.32 in the t-PRK group. This was below the 0.2D non-inferiority margin and not significantly different (p=0.2253). At 6 months, there were no significant differences in MRSE, IOP, UDVA, and CDVA between groups or between t-PRK with or without end-treatment laser polishing, with values demonstrating improved visual acuity in all groups. Two AEs (uveitis [t-PRK group] and COVID-19 infection [PRK group]) were reported; both were deemed unrelated to the procedure.

CONCLUSIONS: Non-inferiority on absolute refractive predictability was demonstrated between PRK and t-PRK, with no significant differences between groups. Both techniques predictably and effectively improved visual acuity in patients with ametropia, with no procedural-related AEs, up to a mean follow-up of 6 months.

PURPOSE: The refractive and visual outcomes of the presbyopic laser algorithm SUPRACOR with two different ablation profiles (strong and regular) using the TECHNOLAS TENEO 317 Model 2 Excimer Laser Platform were evaluated in this prospective, 12-month, randomized, single-surgeon study (NCT04617080).

METHODS: Sixty patients with presbyopia (36 myopic, 24 hyperopic) were treated bilaterally, with the dominant eye treated using the aspheric ablation profile PROSCAN, and the non-dominant eye randomized (1:1) to either SUPRACOR strong or SUPRACOR regular ablation profile with a refractive target of -0.50D. The primary outcome was binocular uncorrected (U) distance (D) visual acuity (VA) at 3 months. Secondary and other outcomes included manifest refraction spherical equivalent (MRSE), monocular and binocular VA at all distances (U, corrected [C], D, intermediate [I], and near [N]), defocus curve, contrast sensitivity, and patient-reported outcomes measures at 3 months and 12 months of follow up.

RESULTS: At 1-year post surgery, mean logMAR ± standard deviation (SD) binocular UDVA was -0.01±0.04 (regular) and 0.00±0.05 (strong); UIVA was 0.00±0.06 (regular) and 0.00±0.08 (strong); UNVA was 0.09±0.10 (regular) and 0.10±0.12 (strong); and CDVA was -0.01±0.03 (regular) and -0.01±0.04 (strong). Mean MRSE ± SD improved from -1.54±3.13D preoperatively to -0.57±0.47D post-operatively (regular), and from -2.84±2.81D to -0.71±0.56D (strong). No statistically significant differences were observed between groups. Binocular defocus curve reported useful VA (≥0.2 logMAR) up to -2.5D, and patient-reported questionnaires showed high spectacle independence for both groups.

CONCLUSION: Both SUPRACOR ablation profiles demonstrated restoration of VA at distance, intermediate and near distances, with the refractive target met. Patients treated with SUPRACOR regular or strong in the non-dominant eye and PROSCAN in the dominant eye achieved a high level of VA over the full range of distances.

PURPOSE: Perfluorohexyloctane ophthalmic solution (PFHO; MIEBO) is indicated for the treatment of signs and symptoms of dry eye disease (DED). This study evaluated patient perceptions and satisfaction early in treatment with PFHO.

METHODS: This prospective, multicenter, open-label, phase 4 study (NCT06309953) enrolled adults with history of DED for ≥6 months, tear film breakup time (TFBUT) ≤5 sec, Schirmer I test (without anesthesia) score ≥5 mm, Meibomian gland dysfunction (MGD) score ≥3 (range, 0-15), and total corneal fluorescein staining (tCFS) score ≥4 and ≤11 (range, 0-15). PFHO was instilled in both eyes QID for 14 days. Patients completed early outcome surveys on days 1 (baseline), 3, 7, and 14 clinic visits, which assessed DED symptom severity (overall and 8 symptoms) and treatment satisfaction (visual analog scale [0-100]). Primary endpoint was mean change from baseline (CFB) in overall DED symptom severity at Day 7.

RESULTS: 99 patients were enrolled (mean age, 61.3 years; 85.9% females). At baseline, mean scores (both eyes) were: TFBUT, 3.6 sec; Schirmer I test, 14.2 mm; MGD score, 8.3; and tCFS, 5.2. Mean CFB in overall DED symptom severity was statistically significant at Day 7 (baseline: 72.1; Day 7: 27.8; CFB: -44.5 [61.7% reduction]; P<0.0001) and at all follow-up visits p><0.0001). mean cfb was also statistically significant p><0.0001) at all follow-up times for severity of all 8 symptoms eye dryness burning stinging eye itching light sensitivity eye pain eye tiredness eye irritation and blurred vision. median rating of treatment satisfaction was 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 symptoms severity. Treatment satisfaction with PFHO was high.

PURPOSE:

To compare visual acuities from distance to near and patient-reported outcomes of a new hydrophobic acrylic refractive Full Range of Vision(FRoV) intraocular lens(IOL) (LuxLife Bausch+ Lomb(study group)) with that of its monofocal parent IOL (LuxGood IOL, Bausch+ Lomb(control group)) in patients undergoing bilateral cataract surgery.

METHODS:

In this multicenter, prospective, open-label study conducted at seven sites in Spain and Czech Republic, cataract patients(50 years or older) with no ocular comorbidity and maximum preoperative corneal astigmatism of 1.0 D were included. Patients were assigned in a 2:1 ratio to undergo bilateral implantation with LuxLife(N=121) or LuxGood IOLs(N=61). Patients were followed up through months. Outcome measures included binocular CDVA at 4 m, DCIVA at 66 cm, DCNVA at 40 cm(in logMAR), binocular defocus curve, Halos and Glare through a simulator, Patient- Reported Spectacle Independence Questionnaire(PRSIQ) and quality of life and overall satisfaction using the CatQuest-9SF.

RESULTS:

Postoperative binocular CDVA was 20.2 logMAR in 100% in both groups, -0.01+0.07 (study) and(control). LuxLife group had a significantly better DCIVA and DCNVA, 3 and 4 lines respectively. Binocular defocus curve showed an extended range of vision of 3.2 D(study group) and 1.45 D(control group) at 0.2 logMAR. A higher percentage of patients in the study group(81% vs 13%) were spectacle-free at all distances. A statistically significantly higher percentage of patients in the study group(ps0.001) reported no difficulty in reading newspapers(83% vs. 47%) or reading price tags(84% vs. 53%). There were no statistically significant differences between groups in Halo and Glare.

CONCLUSION:

Compared to monofocal parent LuxGood, LuxLife demonstrated superior binocular DCIVA and DCNVA; 80% of the patients implanted bilaterally with the LuxLife IOL were fully spectacle-independent at all distances. LuxLife provided a continuous Full range Of depth of Field(ROF) of 3.2D at 0.2 logMAR without being restricted by photic phenomena.

PURPOSE: To compare the refractive and astigmatic prediction accuracy among different intraocular lens(IOL) power calculation formulas in patients implanted with aberration-free monofocal toric IOL during cataract surgery.

METHODS: This is a retrospective chart review of consecutive case records of patients who underwent cataract surgery with the implantation of an aberration-free aspheric monofocal toric IOL(enVista toric, MX60T) from February 2022 to November 2023 and had postoperative manifest refraction performed one month after the surgery. Outcome measures included the comparison of spherical equivalent(SEQ-PE) and astigmatic(RA-PE) predicted errors from various IOL power calculation formulas (Abulafia-Koch, Kane's, EVO, Castrop's, Hoffer QST, Hill-RBF, and Barrett toric formula) for the implanted power.(Statistical analysis was performed with Eyetemis Analysis Tool).

RESULTS: 131 eyes(56.5% women, 75.9+9.8 years) were assessed. The absolute RA-PE (accuracy) of the IOL formulas evaluated ranged from 0.35 D to 0.51 D. While the absolute RA-PE was comparable for the four formulas, Castrop's IOL formula showed the worst prediction error with the statistically significant difference in the RA-PE when compared with Barrett, EVO, Hoffer's QST, Kane and Abulafia Koch formulas(all p<0.05). for various formulas the absolute spherical equivalent prediction errorseq-pe was 0.160.22 d. while the evo formula showed the least seq-pe compared to others it was statistically significantly lower when compared with hoffer qst and abulafia-kochboth p="0.005).">

CONCLUSION: The astigmatic prediction accuracy of Abulafia-Koch, Kane, EVO, Hoffer QST, Hill-RBF, and Barrett toric IOL formulas was comparable. The spherical equivalent prediction accuracy of Barrett, EVO, and Kane was comparable, although the EVO formula showed the least prediction error among the various IOL formulas compared.

PURPOSE: In patients with dry eye disease, lifitegrast ophthalmic solution 5% (Xiidra) was shown to have a favorable safety profile in 5 randomized, placebo-controlled trials ranging in duration from 12 weeks to 1 year. The majority of ocular adverse events were mild and transient. This postmarketing study examined the long-term safety of lifitegrast.

METHODS: Postmarketing safety data were evaluated from approval in the United States (July 2016) to July 10, 2023, using a company safety database that included reports from providers and patients. Patient exposure was reported as patient treatment years and calculated as the total amount of lifitegrast sold worldwide, divided by 2 single-use containers per patient/day (0.4 mL x 365 days/year). The company database was searched using safety terms of interest (eg, "hypersensitivity"; MedDRA version 26.0) to identify relevant cases. The reporting rate is equal to the number of events of interest divided by patient exposure in hundred patient treatment years.

RESULTS: The cumulative patient exposure with 7 years of worldwide postmarketing safety data was estimated at 789,901 patient treatment years. There were no new safety findings in the database. No overall differences in safety or effectiveness have been observed between elderly and younger adult patients. No evidence from available data suggest that a dosage regimen adjustment is required in elderly patients. The hypersensitivity reporting rate was low: 0.19 cases per hundred patient treatment years.

CONCLUSIONS: Long-term experience with lifitegrast was not associated with identification of new or changing safety signals during routine safety monitoring. These findings support the favorable safety and tolerability profile of lifitegrast in the treatment of patients with dry eye disease.

PURPOSE: Patients with large pupils tend to experience more glare and halos after cataract surgery. This study aimed to evaluate the relationship between preoperative photopic and mesopic pupil size and the frequency, severity, and bothersomeness of glare and halos in patients implanted with a novel full range of vision (FROV) IOL.

METHODS: This study included pooled data from 2 clinical trials of FROV IOL implantation (enVista Envy, Bausch and Lomb). The Envy IOL optics are designed with small and smooth diffractive steps, which reduce in height towards the periphery of the lens, resulting in a change in the energy balance. This asymmetric energy distribution makes the IOL distance dominant. As such, the energy focused on intermediate and near foci decreases as the pupil size increases. All patients completed a Quality of Vision questionnaire, which included questions on the frequency, severity, and bothersomeness of glare and halo. A logistic regression model assessed the relationship between pupil size and glare and halos.

RESULTS: No statistically significant relationship was observed between pupil size and the frequency, severity, and bothersomeness of glare and halos (all p>0.05). The logistic regression model showed that the risk of reporting a severe response to the frequency, severity, and bothersomeness of glare was not affected by pupil size (Photopic pupil: odds ratio (OR) =0.66, p=0.1595; mesopic pupil: OR =0.92, p=0.7389). Likewise, the risk of reporting severe response to the frequency, severity, and bothersomeness of halos was not statistically significant (Photopic pupil: OR =1.3, p=0.0851; mesopic pupil: OR =1.3, p=0.0737).

CONCLUSION: This study showed that pupil size has little or no effect on the frequency, severity, and bothersomeness of glare and halos following envista Envy FROV IOL implantation, indicating good tolerance of the novel FROV IOL to the photic phenomena.

PURPOSE: Ocular surgery can induce inflammatory changes leading to ocular surface changes and accumulating damage. Subsequent symptomology and worsening tear dysfunction can impact patient post-surgical satisfaction. NutriTears (NT) is an oral supplement that improves dry eye symptoms and tear volume. Here we assess the effects of NT on ocular inflammation.

METHODS: This randomized, double-blind, placebo (PBO)-controlled study was conducted at 4 study centers in the US. The study involved 5 visits with follow-up out to Day 56 (±3 days). Participants consumed one soft gel capsule (NT or PBO) per day with their breakfast meal. Matrix metalloproteinase-9 (MMP-9) is an inflammatory mediator that is consistently elevated in the tears of patients with dry eye disease and correlates with disease severity. The presence of MMP-9 was evaluated at baseline and Day 56 using InflammaDry® MMP-9 test kits (QUIDEL®; San Diego, CA, USA).

RESULTS: Of 155 randomized participants, 116 (NT=57; PBO=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;" left eye: day 0="44," day 56="17)," whereas positive tests did not decrease in the pbo group right eye: day 0="45," day 56="48;" left eye: day 0="46," day 56="50)." 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 no serious adverse events were reported.>

CONCLUSION: The administration of one NT 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. These findings suggest NT may be a useful tool in mitigating post-surgery inflammatory processes that may drive the pathophysiology of DED.

PURPOSE: Lifitegrast ophthalmic solution 5% (Xiidra), a leukocyte function-associated antigen-1 (LFA-1) antagonist, is indicated for treatment of signs and symptoms of dry eye disease (DED). This study assessed how lifitegrast reduces CD4+ T cell migration to the cornea and mediates T cell alterations in draining lymph nodes (dLNs) in a murine model of DED.

METHODS: DED was induced in 6–8-week-old mice by exposure to the controlled environmental chamber and subcutaneous injections of scopolamine. Mice were treated with topical lifitegrast (or normal saline [NS]) 3 times daily. DED severity was assessed with corneal fluorescein score (CFS) and T cells were quantified by flow cytometry (FC) of corneal single cell suspensions. Expression of chemokine receptors on T cells from submandibular dLNs was assessed by FC and RT-PCR. T cells from DED mice treated with lifitegrast or NS were sorted and adoptively transferred to RAG knockout mice, and DED severity and T cells (in pooled 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). compared with ns treatment lifitegrast treatment resulted in reduction of ifn secreting cd4 t cell th1 recruitment to the cornea and significant reductions in cxcr3 and ccr4 chemokine receptor expression by fc and cxcr3 mrna levels in cd4 t cells from dlns p><0.05). 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 application of lifitegrast has an effect beyond the ocular surface, directly on dLNs, and show that topical drug application impacts the efferent arm of immunity as well.

PURPOSE: To evaluate the effect of residual manifest refraction spherical equivalent (MRSE) on distance-corrected near visual acuity (DCNVA), patient-reported frequency, severity, and bothersomeness of glare and halos, and satisfaction with near vision in patients implanted with enVista Full Range of Vision (FRoV) IOL.

METHODS: The data from 2 prospective, multicenter, double-masked, controlled clinical trials that evaluated the outcomes in patients undergoing implantation of a full range of vision (FRoV) enVista Envy IOL (Bausch + Lomb) was pooled (N=443) and analyzed. Patients were divided into two groups based on MRSE: (1) within ±0.25 D of emmetropia (plano), (2) outside ±0.25 D of emmetropia (non-plano). The relationship between postoperative MRSE and DCNVA was assessed using a generalized estimating effect (GEE) model. In addition, the relationships of postoperative MRSE with patient-reported frequency, severity, and bothersomeness of dysphotopsia and satisfaction with near vision were assessed.

RESULTS: Postoperatively, the mean MRSE was -0.09 ± 0.42 D. No statistically significant relationship was observed between postoperative MRSE and DCNVA (p=0.1390). The frequency, severity, and bothersomeness of halos or glare were comparable between the plano and non-plano groups (all p>0.05). The risk of poor satisfaction with near vision was higher in the non-plano group than the plano group (odds ratio =2.518); however, the p-value was not statistically significant (p=0.2717).

CONCLUSION: FRoV IOLs have low tolerance to residual MRSE; however, the present study showed that residual MRSE in patients implanted with the enVista Envy FRoV IOL had a negligible effect on the DCNVA outcomes, patient-reported frequency, severity, and bothersomeness of halo and glare, and patient satisfaction with near-vision outcomes.

PURPOSE: To evaluate and compare visual acuity outcomes of two different enhanced monofocal IOLs implanted in patients undergoing cataract surgery.

METHODS: This prospective study included patients who had undergone routine cataract extraction with the implantation of a novel monofocal plus IOL with enhanced intermediate optics (enVista Aspire, Bausch & Lomb) IOL or a monofocal plus (Tecnis Eyhance, Johnson & Johnson Vision). Outcomes measures included a comparison of the uncorrected and corrected visual acuity at distance (UDVA, CDVA), uncorrected intermediate visual acuity (UIVA, at 60 cm), and manifest refraction spherical equivalent (MRSE) between the two groups.

RESULTS: Preliminary analysis showed that the mean postoperative MRSE was -0.45 ± 0.30 D in the Aspire group (N = 16) and -0.04 ± 0.35 D in the Eyhance group (N = 13). The mean UDVA (0.05 ± 0.11 D vs 0.05 ± 0.12 logMAR) and CDVA (-0.02 ± 0.04 vs 0.00 ± 0.06 logMAR) were comparable between the Aspire and the Eyhance IOL groups. The Aspire and the Eyhance groups also showed comparable uncorrected visual acuity at intermediate, corresponding to 0.27 ± 0.11 logMAR and 0.26 ± 0.14 logMAR, respectively.

CONCLUSION: The Aspire and Eyhance IOL groups showed comparable visual acuity outcomes at distance and intermediate. Despite the more myopic manifest refraction spherical equivalent in the Aspire group, the uncorrected distance visual acuity outcomes were precise (as shown by the low standard deviation of the mean) and comparable to the Eyhance group.

PURPOSE: To evaluate the mesopic monocular and binocular visual acuity outcomes following implantation of either a novel Full Range of Vision enVista IOL or monofocal enVista IOL in US subjects undergoing cataract surgery.

METHODS: This prospective, multicenter, randomized, controlled study included cataract subjects who underwent bilateral implantation of either enVista Envy full range of vision (FRoV) IOL (study group, N=284) or enVista monofocal IOL (control group, N = 142). Outcome measures included assessment of the monocular and binocular distance-corrected visual acuity at intermediate (DCIVA, 66 cm) and near (DCNVA, 40 cm) under mesopic conditions at postoperative 120-180 days.

RESULTS: Postoperatively, the FRoV group showed significantly better mean mesopic DCIVA (monocular 0.29 ± 0.14 vs 0.46 ± 0.16 logMAR and binocular 0.21 ± 0.12 vs 0.39 ± 0.13 logMAR) compared to the monofocal group (both p<0.0001). similarly the mesopic dcnva was also statistically significantly better in the frov group monocular 0.35 0.15 logmar vs 0.66 0.18 logmar and binocular 0.26 0.13 logmar vs 0.59 0.15 logmar compared to the monofocal group both p><0.0001).>

CONCLUSION: The Envy FRoV IOL showed good binocular mesopic DCIVA (20/32) and DCNVA (20/37), suggesting that the FRoV IOL had good efficacy even under mesopic conditions. While the Envy FRoV group demonstrated a mean binocular DCIVA of more than 2 lines better, the mean DCNVA was approximately 4 lines better than the monofocal group.

PURPOSE:

To evaluate the safety and effectiveness of laser-assisted in situ keratomileusis (LASIK) performed with Teneo 317 Model 2 using the latest laser ablation algorithm (Proscan 1.28 SW) in a subgroup of patients with preexisting corneal astigmatism of 1.50 D or higher.

METHODS:

This prospective, multicenter, open-label, non-randomized, single-arm study included 71 eyes that underwent LASIK with the Teneo 317 Model 2 (version 1.28 US SW, B&L) for the correction of myopia/myopic astigmatism. Inclusion criteria were eyes with preoperative best corrected distance visual acuity (CDVA) of 20/25 or better, manifest refraction spherical equivalent (MRSE) between -1.00 to -11.50 D, and preoperative astigmatism of - 1.50 to -3.00 D, without static cyclotorsion compensation. Outcome measures were uncorrected and corrected distance visual acuity (UDVA, CDVA), MRSE and astigmatism assessed at 9 months postoperatively.

RESULTS:

At postoperative 9 months, 87.3% of eyes achieved UDVA of 20/25 or better, and 98.6% achieved 20/40 or better. While 70.4% of the eyes showed no change in the lines of CDVA, 28.1% of the eyes gained 1 or more lines of CDVA. None of the eyes lost any line of CDVA. Mean MRSE improved from -6.28 +/-2.44 D preoperatively to -0.07 +/-0.32 D postoperatively with 90.1% and 98.6% of eyes achieving residual refractive error within +/- 0.50 D and +/- 1.00 D, respectively. The percentage of eyes with a residual refractive cylinder of 0.50 D and 1.00 D or less were 85.9% and 97.2%, respectively. Refractive outcomes were stable from postoperative 3 to 9 months.

CONCLUSION:

LASIK with Teneo 317 Model 2 excimer laser in patients with preoperative astigmatism of 1.50 D or higher is safe and effective, resulting in good visual and refractive outcomes that were stable through the last follow-up at 9 months. In the real world, with static cyclotorsion compensation, the astigmatic outcomes will likely improve further

PURPOSE: Lifitegrast ophthalmic solution 5% (Xiidra) is indicated for the treatment of signs and symptoms of dry eye disease (DED). The purpose of this study was to examine real-world utilization and outcomes of lifitegrast ophthalmic solution in patients with DED via quantitative (provider survey) and qualitative (case studies) analyses.

METHODS: Eyecare providers (12 ECPs: 6 ophthalmologists and 6 optometrists) treating patients with DED were invited to complete a provider survey. The survey included items regarding timing and degree of symptom resolution with lifitegrast treatment, satisfaction with onset of action, and effectiveness of lifitegrast in treating DED (rated on a scale from 0 [very dissatisfied]) to 10 [very satisfied]). The survey also evaluated use of lifitegrast in patients with DED combined with other ocular conditions (eg, contact lens wear; refractive, cataract, and vitreoretinal surgery; keratoplasty). ECPs also provided case study data for up to five patients with DED who initiated lifitegrast treatment.

RESULTS: 12 ECPs treated an average of 1288 patients with DED annually, with 21% of these patients, on average, receiving lifitegrast. 7 ECPs provided 33 case reports. Nearly all ECPs (92%) reported treating contact lens–induced DED with lifitegrast. Other predominant uses of lifitegrast included DED prior to or after refractive or cataract surgery (83% each). Two-thirds (67%) of ECPs reported near/complete symptom resolution in patients after 1-3 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).

CONCLUSIONS: Quantitative survey and qualitative case data highlight the rapid and durable response associated with lifitegrast for the treatment of patients with DED. Lifitegrast is used frequently in the management of DED in contact lens wearers and in patients undergoing various ocular surgeries.

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 in 3 groups: patients without cataract (or pseudophakia), patients with concomitant cataract, and patients with pseudophakia.

RESULTS: Of 1217 patients overall (n=614 PFHO; n=603 saline), there were 667 patients without cataract, 411 with cataract, and 139 with pseudophakia. Consistent with overall population, reductions (ie, improvements) in tCFS and eye dryness scores were greater for PFHO vs control in all 3 subgroups. At Week 8, least-squares mean reductions from baseline in PFHO/control groups for tCFS were 2.5/1.3 (P<0.0001), 1.9 0.9 p="0.0003)," and 1.1 0.5 p="NS)" for patients without cataract with cataract and with pseudophakia respectively and for eye dryness were 29.3 19.4 p><0.0001), 28.0 19.3 p="0.0015)," and 26.2 21.1 p="NS)" for patients without cataract with cataract and with pseudophakia respectively.>

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.

PURPOSE: Patient satisfaction with visual function and perception of dysphotopsias after multifocal FRoV IOL implantation has been associated with residual astigmatism. This study evaluated the effect of residual astigmatism on patient satisfaction with vision at near, as well as the effects on dysphotopsias in patients implanted with a novel FRoV IOL.

METHODS: Postoperative 6 months data of the residual cylinder from 2 prospective, multicenter, clinical trials of a full range of vision (FRoV) enVista Envy IOL (Bausch + Lomb) was collected and analyzed. The residual cylinder values were converted to negative cylinder notation for analysis. The worst residual cylinder over both eyes was considered for analysis. The relationships of residual cylinder with frequency, severity, and bothersomeness of glare and halos and patient satisfaction with near vision were assessed using a logistic regression model.

RESULTS: For patient satisfaction with near vision, the model results suggest that the chances of poor satisfaction reduce as the magnitude of residual astigmatism decreases (odds ratio=0.077, p=0.0212). No statistically significant relationship was observed between the residual cylinder and the frequency, severity, and bothersomeness of glare and halos (all p>0.05). Logistic regression found that residual cylinder was not a predictor of severe response to frequency, bothersomeness, and severity of glare (odds ratio=1.7, p=0.4209) or halos (odds ratio=1.6, p=0.1945).

CONCLUSION: The present study results showed that patients with lower amounts of residual astigmatism exhibited better postoperative satisfaction. The residual cylinder following the implantation of enVista Envy FRoV IOL had no statistical effect on the frequency, severity, and bothersomeness of glare and halos.

PURPOSE: To study the association between hyperosmolarity and ocular light scatter in a cataract surgery population.

METHODS: In a prospective, observational study, contiguous 20 second ocular scatter index (OSI) scans were recorded in hyperosmolar (≥320 mOsm/L) and normal subjects (<308 mosm l with cataract nuclear opacity 3. osi was measured at screening baseline and 90 days following surgery. along with symptoms of ocular surface disease slit lamp examination included corneal staining 03 tear film breakup time tbut and evaluation of meibomian gland disease mgd. an additional cohort of hyperosmolar subjects were measured for osi at screening baseline and 5 10 15 and 30 minutes following instillation of 0.18 sodium hyaluronate ha.>

RESULTS: Thirty-one eyes of 31 patients were included in the analysis. In the group with cataract nuclear opacity ≥3 (n=21), there was a significant difference in postoperative OSI variation when comparing patients with or without hyperosmolarity post-surgery (0.65±0.30 [n=11] vs 0.33±0.11 [n=10], p=0.005), with variations in the order of 2–3 OSI in hyperosmolar eyes. These changes were not significant when patients were stratified using standard measurements, i.e., staining (p=0.891), TBUT (p=0.749), symptoms (p=0.719), or MGD status (p=0.852). In the hyperosmolar group (n=10), instillation of HA reduced OSI at 10, 15, and 30 minutes (p<0.001).>

CONCLUSIONS: Hyperosmolar eyes exhibited increased light scatter variation following cataract surgery compared with normal osmolarity eyes, which results in a 7-fold increase in post-surgical dissatisfaction. Therefore, hyperosmolarity may represent a key factor to address in order to improve patient outcomes and overall satisfaction after cataract surgery.

PURPOSE: Brimonidine tartrate ophthalmic solution (0.025%; BTOS) contains benzalkonium chloride (BAK), the most used preservative in ophthalmic pharmaceuticals. Exposure of the ocular surface to BAK can induce/exacerbate irritation. A preservative-free formulation of BTOS (BTOS-PF) has been developed and the two formulations are evaluated in this study.

METHODS: This was a multicenter, double-masked, randomized, active-controlled, parallel-group study in healthy adults (>18 years) with ocular redness, conducted at 6 US sites. The study occurred over 5 weeks out to Visit 4 (Day 36 + 1 day). After the initial in-office dose at Visit 1, 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) at Visit 1.

RESULTS: 380 participants were randomized 1:1 to receive BTOS-PF or BTOS and formed the ITT population. 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 (TEAEs) were reported by 37/188 (19.7%) subjects in the BTOS-PF group and 61 TEAEs reported by 39/190 (20.5%) subjects in the BTOS group.

CONCLUSION: 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 favourable and similar to that of BTOS.

PURPOSE: To explore cataract surgeons' real-world experience with an intraocular lens (IOL), enVista ASPIRE™ (EA) and/or enVista ASPIRE™ toric (ETA), including healthcare provider (HCP) satisfaction and IOL utilization patterns.

METHODS: This retrospective, cross-sectional, multicenter study included US cataract surgeons with ≥3 years' experience conducting cataract surgery with monofocal and/or toric IOLs, including EA/ETA IOL implantation on ≥5 patients. Participants completed a retrospective user-experience survey about their initial experience with EA and/or ETA. The study protocol received exemption from a central institutional review board. Survey outcomes included baseline characteristics, patient outcomes, and HCP satisfaction with EA and ETA. A standardized case report form was used to collect clinical and adverse outcomes. This abstract presents the findings from the retrospective user-experience survey.

RESULTS: Survey responses from 6 HCPs were included in the analysis. They performed a mean±SE of 1950±585 cataract surgeries a year, and had previously implanted a mean±SE total of 84±35 EA and 38±18 ETA IOLs. Of the patients treated in the last year, the most commonly implanted IOL (mean±SE, 37.8±10.6%) was full range of vision. Toric IOLs were used in a mean±SE 42.5±12.6% of cases. On a scale of 0 (very dissatisfied) to 10 (very satisfied), 83% and 100% of surgeons rated their satisfaction with the overall performance of the EA and ETA IOL, respectively, as ≥9. Similar ratings were obtained for individual lens qualities and outcomes (e.g., centration, rate of visual disturbances, visual outcomes).

CONCLUSION: This retrospective multicenter study provides important insights into real-world IOL utilization patterns. HCPs reported high satisfaction overall and across key lens qualities and outcomes with EA and ETA IOLs.

PURPOSE: Ocular surgery procedures can exacerbate or induce dry eye. Nutritional supplementation can support eye health and help mitigate pre- and post-surgical issues. NutriTears (NT) is an oral supplement containing lutein & zeaxanthin isomers, curcuminoids, and vitamin D3. This study evaluated the efficacy and safety of NT in participants with dry eye.

METHODS: This randomized, double-blind, placebo (PBO)-controlled study was conducted at 4 US study centers. Participants were required to meet the following criteria in ≥1 eye: (1) Schirmer's test without anesthesia ≤10 mm; and (2) Ocular Surface Disease Index (OSDI) test symptoms 12–40. Participants were also required to have in ≥1 eye: (1) Tear film break-up time ≤10 seconds; (2) Tear osmolarity ≥316 mOsm/L; or (3) Fluorescein corneal staining ≥1 and <3. the study involved 5 visits with follow-up out to day 56 3 days. participants consumed one soft gel capsule per day with breakfast.>

RESULTS: Of 155 randomized participants, 116 (NT=57; PBO=59) completed the study. A significant group-by-time interaction was detected for OSDI Total Score as well as the subscale domains for Symptoms, Vision and Environmental (p<0.001 for all. values for the osdi total score symptoms and vision domains were significantly lower in the nt group vs pbo at days 14 p><0.05), 28 p><0.05) and 56 p><0.001). schirmers test mean standard deviation of both eyes was 7.3 3.29 mm for nt and 7.61 2.37 mm for pbo at baseline 11.6 3.89 mm for nt and 8.22 2.44 mm for pbo at end of treatment p><0.001). one subject from each group reported 1 adverse event no serious adverse events were reported.>

CONCLUSION: The administration of one NT soft gel capsule per day for 8 weeks was effective at improving dry eye symptoms across OSDI domains and tear volume as measured by Schirmer's test compared with PBO. Given the potential impact of pre- and post-surgery dry eye symptoms on outcomes, NT may be a viable surgical adjunct.

PURPOSE: To evaluate the real-world safety, refractive outcomes, and visual acuities in cataract surgery patients implanted with an enhanced monofocal IOL (enVista Aspire, Bausch and Lomb) optimized for intermediate vision.

METHODS: Retrospective, single-site study of 400 eyes that underwent implantation of an enhanced monofocal plus IOL between October 2023 to October 2024. Outcome measures included uncorrected and corrected distance visual acuity (UDVA and CDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA), manifest refraction spherical equivalent (MRSE), and postoperative complications. Current data of 94 postoperative eyes included 77 eyes targeted for emmetropia and 17 eyes with a myopic offset of >-0.75 D (near-targeted eyes).

RESULTS: In emmetropia-targeted eyes, mean postoperative UDVA, CDVA, UIVA, and UNVA were 0.15±0.12, 0.03±0.08, 0.17±0.09, and 0.32±0.12 logMAR respectively. With a mean MRSE of 0.38±0.38 D, UDVA, and UIVA of 20/30 or better were achieved in 77.9% and 79.2% of eyes, respectively, and UNVA of 20/40 or better in 50.6% of eyes. In near-targeted eyes, the mean postoperative UDVA, CDVA, UIVA, and UNVA were 0.46±0.25, 0.07±0.07, 0.02±0.08, 0.14±0.15 logMAR respectively. With a mean MRSE of -1.47±1.01 D, UDVA and UNVA of 20/40 or better were achieved in 41.2% and 88.2% of eyes respectively, and UIVA of 20/30 or better in 100% of eyes. The overall incidence of YAG capsulotomy was 4.3%.

CONCLUSION: The intermediate-optimized monofocal plus IOL yielded good visual and refractive outcomes with acceptable safety profile. Patients targeted for emmetropia achieved commendable distance, usable intermediate, and functional near vision. With a myopic offset, the intermediate and near vision outcomes improved further.

PURPOSE: To identify the prevalence of hyperosmolar tear film in a pre-surgical (pre-Sx) cataract and 30-day post-surgical (post-Sx) patient population.

METHOD: This was a prospective, observational cohort study at the Cincinnati Eye Institute, Cincinnati, Ohio. Subjects presenting for pre-Sx cataract evaluations were selected randomly. Tear fluid osmolarity was measured bilaterally at pre-Sx evaluation and at the 30-days post-Sx visit using the ScoutPro Osmolarity System (Bausch & Lomb, New Jersey). The higher of the two eyes was used for clinical assessment at each time point. A cut-off of ≥ 315 mOsm/L was selected to define cohorts with visually significant ocular surface disease (OSD) per the American Society of Cataract and Refractive Surgery algorithm for preoperative diagnosis and treatment of ocular surface disease.

RESULTS: 71 subjects were tested (mean age 63.1±14.8; 45 Females, 26 Males), of which 31 subjects (44%) exhibited elevated osmolarity ≥ 315 mOsm/L. At the 30-day post-surgical visit, 59 of the original 71 subjects followed up. 31% of the pre-Sx normal (is normal < 308 or less than 315?) subjects became hyperosmolar post-surgery. Only 50% of the pre-Sx hyperosmolar patients normalized despite topical corticosteroid, NSAID, anti-bacterial and artificial tear treatment during the post operative period.

CONCLUSION: Hyperosmolarity is common 30 days following cataract surgery suggesting an impact on the ocular surface unresolved by standard therapeutic routine. Risk of elevated light-scatter and visually significant sequelae from a hyperosmolar tear film may lead to poor patient satisfaction and visual quality requiring additional targeted therapy.

PURPOSE: Many patients have some degree of corneal astigmatism; even mild amounts of astigmatism can impact post-operative visual outcomes following cataract surgery. This case series aims to present real-world clinical outcomes of patients implanted with a low-powered toric (1.25D) enVista ASPIRE™ IOL (ETA) to correct for mild corneal astigmatism.

METHODS: This retrospective case series includes a single surgeon's experience implanting ETA between 23 January and 23 April 2024. All eyes were implanted with a low-powered ETA lens (1.25D) to correct for mild corneal astigmatism. Outcome measures included spherical equivalent refractive (SEQ) outcomes, best-corrected distance visual acuity (BCDVA), uncorrected VA (distance and intermediate), delta Ks, and refractive residual cylinder. The study protocol received exemption from a central institutional review board.

RESULTS: ETA 1.25D was implanted in 9 eyes of 8 pts (4 OD, 3 OS, 1 OU); 4 pts underwent bilateral implantation with an ETA lens >1.25D in their fellow eye. At baseline, mean±SE delta K and SEQ target were 0.78±0.09 and 0.03±0.09 (N=9 eyes). At follow-up, mean±SE SEQ outcome and difference were 0.01±0.15 and -0.01±0.08, respectively; mean±SE refractive and corneal residual cylinder were 0.35±0.14 and 0.84±0.14, respectively (N=9 eyes). At follow-up, 89% of eyes achieved 20/20 or better and 100% of eyes achieved 20/25 or better BCDVA; 89% of eyes achieved 20/25 or better UCDVA; 78% of eyes achieved 20/32 or better UCIVA (N=9 eyes). For eyes implanted bilaterally, 100% achieved 20/20 BCDVA OU (N=5 pts).

CONCLUSION: This single surgeon case series demonstrates good vision outcomes for patients with mild corneal astigmatism implanted with this low-powered toric monofocal IOL. Further data are required to understand how this single-surgeon's experience is reflected more broadly in real-world clinical practice.

PURPOSE: To evaluate the safety and effectiveness of laser-assisted in situ keratomileusis (LASIK) performed with Teneo 317 Model 2 using the latest laser ablation algorithm (Proscan 1.28 SW) for the correction of high myopia (-6.0 D or higher).

METHODS: This prospective, multicenter, open-label, non-randomized, single-arm study included 158 eyes that underwent LASIK with the Teneo 317 Model 2 (version 1.28 US SW, Bausch & Lomb) for the correction of high myopia (-6.0 D or higher). Inclusion criteria were eyes with preoperative best-corrected distance visual acuity (CDVA) of 20/25 or better, manifest refraction spherical equivalent (MRSE) between -6.0 D and -11.50 D with or without astigmatism (cylinder between 0.0 D and -3.0 D). Outcome measures were uncorrected and corrected distance visual acuity (UDVA, CDVA), MRSE and astigmatic outcomes, 9 months postoperatively.

RESULTS: At postoperative 9 months, 94.8% of eyes achieved UDVA of 20/25 or better, and 100% achieved 20/40 or better. While 67.1% of the eyes showed no change in the lines of CDVA, 32.2% of the eyes gained 1 or more lines of CDVA. Mean MRSE improved from -7.96 ± 1.22 D preoperatively to -0.07 ± 0.39 D postoperatively with 87.7% and 98.1% of eyes achieving residual refractive error within ±0.50 D and ±1.00 D, respectively. The percentage of eyes with a residual refractive cylinder of ≤0.50 D and ≤1.00 D were 90.3% and 99.4%, respectively. Refractive outcomes were stable from postoperative 3 to 9 months.

CONCLUSION: LASIK performed with the Teneo 317 Model 2 excimer laser is safe and effective for correcting high myopia (with or without astigmatism), resulting in good visual and refractive outcomes that were stable through the last follow-up at 9 months.

PURPOSE: Relief of post-surgical ocular redness can be achieved with topical ophthalmic vasoconstrictors. Adverse events (AEs) associated with sustained use of α-adrenergic receptor (AR) agonists include tachyphylaxis and rebound redness. Here we investigate whether brimonidine tartrate ophthalmic solution (0.025%; BTOS) is associated with such AEs.

METHODS: BTOS is a selective α2-AR agonist, with a relative binding affinity for α2 vs α1 of ~1000:1, exhibiting potent vasoconstrictor activity at concentrations as low as 0.025%. In contrast, other approved topical ophthalmic vasoconstrictors are either α1-AR agonists (e.g., tetrahydrozoline) or mixed α1/α2-AR agonists (e.g., naphazoline/oxymetazoline), with α2:α1 binding affinities of around 2:1 or 5:1, respectively. We reviewed pharmacovigilance data for BTOS covering a period (05/2018–12/2022) when 49.9 million units were sold. AE reports that may be associated with overuse and subsequent increased redness (dependent on MedDRA coding) were noted.

RESULTS: In total, there have been 341 reports of ocular hyperaemia, 60 reports of rebound effect and 9 reports of symptom recurrence. In addition, there were 503 reports of drug ineffective (and 6 of drug effect less than expected), 423 reports of therapeutic product effect incomplete, 71 reports of effect decreased and 1 report of effect shortened. While it is important to note that reports of AEs do not establish causality, and the voluntary nature of self-reporting can result in an underestimation of the true incidence, this post-marketing real-world AE profile provides insight into the longer-term safety of BTOS, with few reports of tachyphylaxis and rebound redness.

CONCLUSION: The specific action of brimonidine on α2-ARs is hypothesised to reduce the potential for AEs associated with overuse and contribute to a distinct safety profile.

PURPOSE: To evaluate initial clinical outcomes of laser-assisted in-situ keratomileusis (LASIK) performed with the latest excimer laser (Technolas Teneo 317, Model 2) using an aspheric ablation profile for correcting myopia and myopic astigmatism.

METHODS: This retrospective study included patients who underwent LASIK performed using the new Technolas Teneo 317 Model 2 excimer laser (version 1.28 US SW) by Bausch and Lomb, using the latest aspheric ablation profile. No nomogram adjustments were made, and the patient's manifest refraction was used for the laser treatment. Study parameters included uncorrected and corrected distance visual acuity (UDVA and CDVA), manifest refraction spherical equivalent (MRSE), and astigmatism.

RESULTS: Data from 47 eyes were analyzed. The mean age of 25 patients was 33.4±7.9 years. There were 44% males and 56% females. The mean preoperative CDVA was -0.05±0.09 logMAR and all (100%) eyes had CDVA of 20/30 or better preoperatively. At postoperative 1 month, the uncorrected visual acuity was -0.07±0.07 logMAR, with 100% of eyes achieving UDVA of 20/25 or better. The mean postoperative MRSE was -0.16±0.37 D, with 89.4% and 97.9% of eyes achieving postoperative MRSE within 0.50 D and 1.00 D, respectively. The mean postoperative cylinder was 0.18±0.23 D and 93.6% of eyes showed refractive astigmatism within 0.50 D.

CONCLUSION: LASIK performed with the Teneo 317 Model 2 excimer laser using an aspheric ablation profile for correcting myopia and myopic astigmatism yielded excellent visual and refractive outcomes. These outcomes were achieved using the patient's manifest refraction with no nomogram adjustments.

PURPOSE: Perfluorohexyloctane ophthalmic solution (PFHO; MIEBO) is indicated for the treatment of signs and symptoms of dry eye disease (DED). This study evaluated patient-reported symptoms early in treatment with PFHO.

METHODS: This prospective, multicenter, open-label, phase 4 study (NCT06309953) enrolled adults with a history of DED for ≥6 months. PFHO was instilled in both eyes 4 times daily for 14 days. Patients completed early outcome surveys during 4 clinic visits (baseline and days 3, 7, and 14). The primary outcome (symptom severity) is presented separately. Secondary outcomes included patient-reported frequency (percentage of time experiencing) of the most bothersome symptom, awareness of dry eye symptoms, and fluctuations in quality of vision.

RESULTS: The "most bothersome" symptom at baseline (n=99 patients) was eye dryness (28.3%), blurred vision (17.2%), eye irritation (14.1%), light sensitivity (13.1%), eye tiredness (12.1%), burning/stinging (11.1%), or eye itching (4.0%). Mean frequency (percentage of time) experiencing the most bothersome symptom decreased significantly (P<0.0001) from 77.9 at baseline to 46.7 at day 3 41.3 at day 7 and 34.7 at day 14. significant p><0.0001) decreases were also observed in mean frequency of awareness of dry eye symptoms 77.6 at baseline 39.7 at day 3 32.6 at day 7 27.6 at day 14 and fluctuations in quality of vision 62.8 at baseline 29.8 at day 3 24.5 at day 7 19.4 at day 14.>

CONCLUSIONS: Early in the course of treatment with PFHO, patients with DED experienced significant reductions in the frequency of dry eye symptoms, including the patient-specific most bothersome symptom.

PURPOSE: Chord Mu is a new reference marker to predict outcomes after multifocal intraocular lens (IOL) implantation. The relationship of chord mu with distance-corrected near visual acuity (DCNVA), the incidence of halos and glare, and patient satisfaction was assessed with near vision in patients implanted with a novel Full Range of Vision (FRoV) IOL.

METHODS: This study included 110 patients who underwent cataract surgery and FRoV IOL implantation (enVista Envy MX60EFH, Bausch and Lomb). The value of chord Mu was measured using IOLMaster (Zeiss). Data were divided into two groups based on the chord Mu threshold of 0.6 mm: Group 1 included eyes in which the Chord Mu was ≤0.6 mm and Group 2 included those in which the Chord Mu was >0.6 mm. The relationships of chord Mu with DCNVA and frequency, severity, and bothersomeness of glare and halo and satisfaction with near vision were assessed.

RESULTS: The data of 218 eyes were available for analysis. The GEE model demonstrated no statistically significant relationship between Chord Mu and DCNVA (p=0.7325). There were no differences in the frequency, severity, and bothersomeness with halos or glare between the two groups (all p>0.05). Logistic regression found that Chord Mu is not a predictor of severe response to frequency, severity, and bothersomeness of glare (odds ratio (OR)=0.016, p=0.3704) or halos (OR=1.393, p=0.8414). For patient satisfaction with near vision, the model suggested that subjects with a larger chord Mu are less likely to report poor satisfaction on the Near Activity Visual Questionnaire (odds ratio=0.003, p=0.0221).

CONCLUSION: Longer Chord Mu has been associated with poorer near-vision outcomes with multifocal IOL implantation. In the present study, however, we found no effect of chord mu on the distance-corrected near visual acuity outcomes, patient-reported frequency, severity, and bothersomeness of glare and halos, or satisfaction with near vision.

PURPOSE: Perfluorohexyloctane ophthalmic solution (PFHO; MIEBO), 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 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. Eligible patients had linkage to the IQVIA Professional Fee Claims database and a 12-month pre-initiation period ("baseline") for sample characterization. For patients initiating treatment in September or October 2023, 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%). Nearly 100 ocular surface disease ICD-10-CM codes were used to understand DED recording for claims. 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. CsA 0.05% (21.8%) and lifitegrast (17.1%) were most commonly used. The 60-day refill rate for PFHO was 67.3% versus 26.2% for CsA 0.05% initiators (n=75,871).

CONCLUSIONS: Overall, early adopters of PFHO were consistent with the epidemiology of DED. DED may be under-coded in claims, given that only <40% of patients had ded claims. the higher refill rate for pfho versus csa 0.05 suggests a higher degree of patient satisfaction and clinical benefit with this new first-in-class treatment for ded.>