- Study met its primary and key secondary endpoints, demonstrating rapid and sustained improvement in near visual acuity
- Safety profile consistent with previous clinical trials and no treatment-related serious adverse events reported in the study
- No evidence of tachyphylaxis was observed in this study over the 6-week period
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RESEARCH TRIANGLE PARK, N.C., June 26, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (NASDAQ:IRD), a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders, today announced positive topline results from VEGA-3, its second pivotal Phase 3 trial evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia. Presbyopia is an ophthalmic disorder that involves the progressive loss of ability to focus on close objects that results in blurred near vision, difficulty seeing in dim light, and eye strain.
The VEGA-3 trial met its primary endpoint, with a statistically significant 27.2% of participants treated with Phentolamine Ophthalmic Solution 0.75% achieving a ≥15-letter improvement in binocular distance-corrected near visual acuity (DCNVA), with less than a 5-letter loss in binocular best-corrected distance visual acuity (BCDVA) at 12 hours post-dose on Day 8, compared to 11.5% of patients on placebo (p<0.0001). The trial also met key secondary efficacy endpoints, reinforcing the benefit observed.