BACKGROUND: Brimonidine tartrate ophthalmic solution 0.025% (Lumify®; BTOS) provides rapid ocular redness relief with very low risk of rebound redness or tachyphylaxis. Several marketed lubricant eye drops contain hyaluronic acid (HA). HA is a natural component in tears that helps to keep the eye moisturized and protects the eye from mechanical stress during blinking. A new BTOS formulation containing HA (BTOS-HA) has been developed.

METHOD: In this Phase 3, randomized, double-masked, active-controlled, parallel-group study at 11 US sites, adults with ocular redness (investigator-graded pre-instillation score >1 in both eyes on a 0–4 scale with half-unit increments) were randomized 1:1 to BTOS-HA or BTOS. Subjects received 1 drop in each eye 4 times daily for approximately 4 weeks. The primary endpoint was investigator-graded ocular redness on Day 1 at 5, 15, 30, 60, 90, 120, 180, and 240 minutes post-instillation. Noninferiority required the upper bound of the two-sided 95% confidence interval (BTOS-HA minus BTOS) to be ≤0.22 units at all 8 time points.

RESULTS: A total of 578 subjects were randomized to either BTOS-HA (N=289) or BTOS (N=289), with 575 receiving ≥1 dose. The mean (SD) pre-instillation redness score was 2.269 (0.5241) for BTOS-HA and 2.230 (0.5434) for BTOS. Post-instillation redness scores were low and similar between groups across all 8 time points on Day 1. Mean differences ranged from −0.007 to 0.025 units, with upper confidence limits ≤0.103, thereby meeting the primary endpoint of the study. Ocular and non-ocular treatment-emergent adverse event (TEAE) rates for BTOS-HA and BTOS were comparable. In the BTOS-HA group, instillation-site irritation (1.7%) was the only ocular TEAE reported in ≥1% of subjects. All ocular TEAEs in either group were mild or moderate. Serious TEAEs (BTOS-HA n=1; BTOS n=2) were non-ocular and unrelated to treatment.

CONCLUSION: BTOS-HA was noninferior to BTOS for Day 1 redness reduction through 4 hours and demonstrated a favorable safety and tolerability profile, offering a novel HA-containing formulation with comparable efficacy to BTOS.

BACKGROUND: Age-related macular degeneration (AMD) is driven in part by oxidative damage and inflammation, contributing to progressive dysfunction of the retinal pigment epithelium (RPE) and neurosensory retina. The AREDS and AREDS2 formulations provide antioxidant and micronutrient support to slow disease progression; however, the potential additive benefits of B vitamins on RPE protection have not been evaluated. B vitamins regulate mitochondrial metabolism, homocysteine balance, and oxidative stress, suggesting a possible complementary effect alongside current AREDS2 nutrients. This study compared the effects of AREDS2 components, B vitamins, and their combination on cytoprotection and gene expression in an iPSC-derived RPE AMD model.

METHOD: Human iPSC-derived RPE cells from donors carrying high-risk AMD alleles (ARMS2/HTRA1) were treated with A2E and blue light to model AMD after pretreatment with AREDS2 components, B vitamins, or their combination. Cell viability was evaluated using Calcein AM assays. Transcriptomic changes were assessed by bulk RNA sequencing, and differential expression (DESeq2) was analyzed for Gene Ontology (GO) and KEGG pathway enrichment.

RESULTS: Exposure to either AREDS2 components alone or the combination of AREDS2 components and B vitamins significantly improved RPE cell viability in the AMD model. Distinct gene expression profiles were observed following exposure to AREDS2 components versus the combined treatment, with the combination inducing additional pathways associated with antioxidant defense and overall RPE health, suggesting enhanced stress adaptation and cellular recovery capacity.

CONCLUSION: Although exposure to B vitamins alone did not significantly improve cell viability or drive major transcriptional changes, their combination with AREDS2 components was protective in an in vitro AMD model. The combined treatment also elicited additional gene expression responses related to oxidative stress and RPE survival pathways compared with AREDS2 components alone, indicating a potential additive or synergistic effect.

BACKGROUND: Vyzulta (latanoprostene bunod; LB) is a topical prostaglandin analog for intraocular pressure (IOP) reduction in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). This study assessed real-world LB use in patients with OAG or OHT.

METHODS: This retrospective, multicenter, cross-sectional case review and survey study included licensed ophthalmologists/optometrists (eye care practitioners; ECPs) with ≥3 years’ experience who prescribed on-label LB in ≥10 patients in the prior year. ECPs submitted deidentified cases via a case report form (CRF) and completed a retrospective survey. Outcomes included IOP, number of IOP-lowering medications, safety, utilization patterns, and ECP satisfaction.

RESULTS: This analysis included CRFs for 83 eyes of 55 patients across five US sites. Mean±standard deviation (SD) age was 68±15 years, and 56% were female; 70% (n=38/54; unknown, n=1) had ocular comorbidities. At baseline, mean±SD IOP (n=81 eyes) was 19.9±6.6 mmHg, with a mean±SD target IOP (n=76 eyes) of 14.6±2.4 mmHg. Median (interquartile range [IQR]) number of IOP-lowering medications (n=55 patients) was 1 (1–2). At most recent follow-up, 87% (n=48/55) of patients remained on LB, with a median (IQR) of 29 (17–52) weeks since treatment initiation. Mean±SD IOP (n=82 eyes) decreased by 32% to 13.5±3.8 mmHg; median (IQR) number of IOP-lowering medications (n=54 patients) was 1 (1–2). Of eleven adverse events in nine patients, decreased visual acuity was the most common. Five ECPs from five US practices completed the survey; all had ≥11 years’ experience and were mostly from medium-sized practices (11–50 ECPs). On average, ECPs prescribed LB as monotherapy in 184 patients and as combination therapy in 186 patients in the prior year, of whom 38% were diagnosed with OAG and 31% were diagnosed with normal-tension glaucoma. Mean ECP-reported effectiveness of LB (0 [very poor] to 10 [very good]) was 9.2 in patients with no prior treatment and 8.0 in patients with failed IOP-lowering drops and failed selective laser trabeculotomy and/or minimally invasive glaucoma surgery. Mean ECP-reported overall satisfaction with LB (0 [very dissatisfied] to 10 [very satisfied]) was 9.2.

CONCLUSION: LB is an effective IOP-lowering treatment in real-world practice, with good clinical outcomes and high levels of ECP satisfaction.

BACKGROUND: Latanoprostene bunod ophthalmic solution 0.024% (LBN) is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The IOP-lowering effects of LBN were demonstrated in randomized controlled trials, and the safety profile was consistent with that of topical prostaglandin analogs. The data reported here evaluated patient and/or provider satisfaction with LBN in clinical settings.

METHOD: Real-world evidence was evaluated in 2 studies: an observational study conducted in Canada and a multinational survey of eyecare providers. The observational study was a prospective, open-label, 6-week, postmarketing study that enrolled adults with elevated IOP and a diagnosis of open-angle glaucoma or ocular hypertension. Outcome measures included patient and physician satisfaction with treatment, rated independently on a scale from 0 (strongly dissatisfied) to 10 (strongly satisfied). The multinational study is a survey of licensed optometrists or ophthalmologists with at least 3 years’ experience who had prescribed LBN on-label to at least 10 patients in the previous 12 months.

RESULTS: The observational study included 59 ophthalmologists and 653 patients. At the 6-week follow-up visit, provider and patient satisfaction ratings were high: mean (SD) score of 7.8 (2.1) for physicians and 7.8 (2.3) for patients. No patients discontinued treatment during the follow-up period. Data collection in the multinational survey study is ongoing.

CONCLUSION: In a real-world patient population treated with LBN, high treatment satisfaction scores were reported by both ophthalmologists and patients. A multinational study assessing clinical practice parameters, LBN utilization patterns, and provider satisfaction is currently underway to determine the generalizability of these results.

PURPOSE: Lifitegrast ophthalmic solution, 5.0%, is an anti-inflammatory agent indicated for treatment of the signs and symptoms of dry eye disease (DED). This post hoc analysis used phase 3 pivotal data to evaluate patterns of response to treatment with lifitegrast in patients with DED.

METHODS: This was an exploratory analysis of data from two 12-week, randomized, placebo-controlled clinical trials: OPUS-2 (NCT01743729) and OPUS-3 (NCT02284516). Cluster analysis was performed using pooled data (lifitegrast treatment arm) to identify homogenous populations of patient response types based on percent 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 excluded from the analysis.

RESULTS: The analysis population included 638 patients who received lifitegrast. Mean (SD) age was 58.4 (14.1) years; most patients were female (77.4%) and White (80.1%). In the overall analysis population, mean (SD) EDS score at baseline was 69.4 (16.9). The cluster analysis identified 5 patterns of response to lifitegrast. The 5 patient subgroups were (1) early sustained responders with at least 60% EDS reduction at all time points (n=113; 17.7%); (2) steady responders with at least 20%, at least 40%, and at least 60% reduction at Days 14, 42, and 85 (n=113; 17.7%); (3) Day 84 response of at least 60% (n=127; 19.9%); (4) Day 84 response of 30% to 60% (n=119; 18.7%); and (5) Day 84 response of less than 30% (n=166; 26.0%). There were significant differences in mean symptom scores across the 5 patient subgroups (P<0.001), with numerically lower mean symptom scores for eye pain burning stinging foreign body sensation and photophobia at days 14 42 and 84 in the patients demonstrating an early sustained response.>

CONCLUSION: After 12 weeks of treatment with lifitegrast, most patients (353 of 638, 55.3%) had at least 60% reduction in their EDS. The group with rapid and sustained EDS reductions by week 2 tended to have lower symptom scores than the other subgroups across the treatment period, suggesting that early treatment may be beneficial for maximal response. Further studies to corroborate these findings are warranted.

BACKGROUND: Autoimmune diseases such as systemic lupus erythematosus (SLE), Sjögren’s syndrome (SS), and rheumatoid arthritis (RA) are strongly associated with dry eye disease (DED), often driven by ocular surface inflammation. Lifitegrast ophthalmic solution 5% (Xiidra®), a lymphocyte function-associated antigen-1 (LFA-1) antagonist, targets T-cell–mediated inflammation, a key mechanism in autoimmune-related DED. This analysis describes real-world characteristics of patients with autoimmune diseases initiating DED treatment with lifitegrast.

METHOD: This retrospective cohort study used the American Academy of Ophthalmology IRIS® Registry linked to pharmacy claims and identified adults with DED who initiated lifitegrast between January 1, 2017, and December 31, 2024. Subgroups included patients with comorbid SLE, SS, or RA diagnosed at or within 12 months prior to lifitegrast initiation. Demographics, comorbidities, and treatment patterns were assessed.

RESULTS: Among 143,005 patients with DED initiating lifitegrast, 2720 (2%) had SLE, 8651 (6%) had SS, and 8249 (6%) had RA. Mean ages were 57, 59, and 62 years, respectively; >90% were female across cohorts. Aqueous tear deficiency predominated (>90% across cohorts). Ocular comorbidities included cataract (37-45%) and glaucoma (6-9%). Nonocular comorbidities were common, including hypertension (44-57%) and other autoimmune conditions (eg, SS in SLE cohort: 38%; RA in SS cohort: 23%). Prior DED therapy included topical cyclosporine (14-19%) and punctal plugs (10-11%). Mean lifitegrast treatment duration ranged from 140 to 150 days.

CONCLUSION: Patients with autoimmune diseases and DED initiating lifitegrast in routine practice exhibited high inflammatory burden and frequent ocular comorbidities. These findings support lifitegrast as a targeted therapy for autoimmune-related DED in real-world settings.