Ocuphire Initiates VEGA-3 Phase 3 Trial Evaluating Phentolamine Ophthalmic Solution 0.75% for Presbyopia

Ocuphire Pharma announced the first dosing of participants in its VEGA-3 phase 3 clinical trial evaluating phentolamine ophthalmic solution 0.75% for the treatment of presbyopia.

Ocuphire’s phentolamine ophthalmic solution 0.75% is being developed as a potential alternative to corrective eyewear, offering convenience and ease of use.

"Our goal is to provide a safe, long-lasting, and effective solution that restores near vision and enhances overall visual performance, both during the day and at night," George Magrath, MD, Ocuphire’s CEO, said in a company news release. "We are pleased to begin the VEGA-3 trial, building on positive outcomes from previous studies that demonstrated rapid onset of action, a favorable safety profile, and sustained efficacy."

The company plans to use data from VEGA-3 to support a supplemental new drug application (sNDA) with the FDA.

VEGA-3 Phase 3 Pivotal Trial Overview

The VEGA-3 trial is a randomized, double-masked, placebo-controlled, multicenter study involving 545 participants with presbyopia. Participants are randomized to receive either phentolamine ophthalmic solution 0.75% or placebo once daily. The primary endpoint is the percentage of participants who achieve a 15-letter improvement in photopic binocular distance-corrected near visual acuity (DCNVA) on day 8 compared to their baseline measurements. Participants will be monitored for 48 weeks to gather comprehensive safety data.

Up to 40 investigational sites across the US are conducting the trial.

Alongside the VEGA-3 trial, Ocuphire is continuing its enrollment for the LYNX-2 phase 3 trial, which is designed to assess phentolamine ophthalmic solution 0.75% in patients who have undergone keratorefractive surgery and experience visual disturbances such as glare, halos, or starbursts in low-light conditions. The study’s primary endpoint is an improvement of three lines (or 15 letters) of distance vision on a low contrast chart under mesopic (low-light) conditions after 15 days of treatment.

Topline data from LYNX-2 are expected in the first quarter of 2025. The trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA, further highlighting the importance of this research.

For more information, visit ClinicalTrials.gov (NCT06542497 and NCT06349759).