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Ocuphire Pharma, Inc. (Nasdaq:OCUP), a clinical-stage biopharmaceutical company specializing in ophthalmic treatments, has announced the commencement of its VEGA-3 Phase 3 clinical trial. The trial is evaluating Phentolamine Ophthalmic Solution 0.75% as a treatment for presbyopia, a common age-related condition characterized by the gradual loss of near vision.
Presbyopia typically becomes noticeable in individuals in their early to mid-40s, leading to reliance on reading glasses or bifocals for near tasks. Ocuphire’s Phentolamine Ophthalmic Solution 0.75% is being developed as a non-invasive, convenient alternative to traditional corrective measures, aiming to restore near vision and enhance overall visual performance.
George Magrath, M.D., M.B.A., M.S., Chief Executive Officer of Ocuphire Pharma, expressed enthusiasm about the trial’s initiation, stating, “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. 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.”
The VEGA-3 trial will assess the efficacy and safety of Phentolamine Ophthalmic Solution 0.75% in a randomized, double-masked, placebo-controlled, multi-center study involving 545 participants with presbyopia. Participants will be randomly assigned to receive either one drop of Phentolamine Ophthalmic Solution 0.75% or a placebo each evening. The primary endpoint of the trial is the percentage of participants who experience a 15-letter improvement in photopic binocular distance-corrected near visual acuity (DCNVA) by the eighth day following their first dose. Participants will be monitored for a total of 48 weeks to gather chronic safety data, with recruitment occurring at up to 40 investigational sites across the U.S.
Ocuphire plans to use the data from the VEGA-3 trial to support a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) if the results demonstrate the efficacy and safety of the treatment.
In addition to the VEGA-3 trial, Ocuphire is progressing with the LYNX-2 trial, with top-line data expected in the first quarter of 2025, contingent on continued enrollment. Dr. Magrath highlighted the team's efforts, noting, “I’m very proud of the work our team and partners have put into the execution of this study.”
The VEGA-3 trial represents a significant step for Ocuphire Pharma as it advances its mission to offer innovative solutions for retinal and refractive eye disorders.
