Ocuphire Pharma (NASDAQ:OCUP) has initiated its VEGA-3 Phase 3 trial, evaluating Phentolamine Ophthalmic Solution 0.75% for presbyopia, with its first dose. Topline results are expected in the first half of 2025.
Participants are randomized 3:2 to receive one drop of either Phentolamine Ophthalmic Solution 0.75% or a placebo each evening, with the primary endpoint being a 15-letter improvement in photopic binocular distance-corrected near visual acuity by day eight.
Presbyopia, a progressive and common age-related decline in near-vision acuity, can manifest in the early to mid-40s, necessitating corrective measures such as reading glasses or bifocals. Phentolamine Ophthalmic Solution 0.75% is currently in development as a non-invasive alternative to these traditional interventions.
The company aims to use VEGA-3 data demonstrating the safety and efficacy of Phentolamine Ophthalmic Solution 0.75% as a potential treatment for presbyopia to support a supplemental NDA with the FDA.
“Our goal is to provide a safe, long-lasting, effective solution that restores near vision and enhances overall visual performance in people with presbyopia, under both daytime and nighttime conditions,” said George Magrath, M.D., M.B.A., M.S., Ocuphire’s Chief Executive Officer. “We are pleased to begin the VEGA-3 trial, building on the positive results generated in our prior presbyopia studies, which have shown a rapid onset of action, favorable safety profile, and sustained duration of effect that are promising at this stage.”
