On June 26, 2025, Opus Genetics, Inc. 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 a common ophthalmic disorder involving the progressive loss of near vision.
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) at 12 hours post-dose on Day 8, compared to 11.5% on placebo (p<0.0001). The trial also met key secondary efficacy endpoints.
These positive results from both the VEGA-2 and VEGA-3 trials support the submission of a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA), which the company plans to file in the second half of 2025. This represents a significant step towards offering a new treatment option for millions of adults affected by presbyopia.
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