Core Insights - Opus Genetics announced positive topline results from the VEGA-3 trial, which evaluated Phentolamine Ophthalmic Solution 0.75% for treating presbyopia, showing significant improvement in near vision for participants [1][2][3] Group 1: Trial Results - The VEGA-3 trial met its primary endpoint, with 27.2% of participants achieving a ≥15-letter improvement in binocular distance-corrected near visual acuity (DCNVA) compared to 11.5% in the placebo group (p<0.0001) [2][7] - Key secondary efficacy endpoints were also met, indicating rapid and sustained improvement in near visual acuity [6] - Significant patient-reported functional benefits were observed, with satisfaction in near vision reported upon awakening (p<0.0001) [7] Group 2: Study Design - VEGA-3 is a multicenter, randomized, double-masked, placebo-controlled Phase 3 study that enrolled 545 participants across 40 sites in the United States [4] - Participants were randomized in a 3:2 ratio to receive either Phentolamine Ophthalmic Solution 0.75% or placebo, administered once daily in the evening [4] Group 3: Safety Profile - The safety profile of Phentolamine Ophthalmic Solution 0.75% was consistent with previous clinical trials, with no treatment-related serious adverse events reported [6][15] - Common treatment-emergent adverse events included conjunctival hyperemia, instillation site irritation, and dysgeusia, all predominantly mild [15] Group 4: Future Plans - The positive results from the VEGA-3 trial support the submission of an application to the U.S. Food and Drug Administration (FDA), planned for the second half of 2025 [3] - Opus Genetics is also advancing Phentolamine Ophthalmic Solution 0.75% in two Phase 3 programs for presbyopia and dim light vision disturbances [11][13]
Opus Genetics Announces VEGA-3 Phase 3 Trial Met its Primary Endpoint for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia