Ocuphire Pharma doses first patient in phase 3 VEGA-3 clinical trial

Ocuphire Pharma announced it has dosed the first patient in its VEGA-3, phase 3 clinical trial (NCT06542497) of phentolamine ophthalmic solution 0.75% for the treatment of presbyopia.

The company noted in a press release¹ that phentolamine ophthalmic solution 0.75% is being developed to provide a non-invasive, convenient alternative to traditional corrective measures for presbyopia.

Ocuphire CEO, George Magrath, MD, MBA, MS, commented on the treatment in the press release from the company 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.”

Previous studies mentioned by Magrath include the VEGA-2 (NCT05646719) trial, which also evaluated phentolamine ophthalmic solution 0.75% for the treatment of presbyopia. The study was a randomized, double-masked, placebo-controlled, multi-center, phase 3 study. It evaluated the efficacy of phentolamine ophthalmic solution 0.75% alone and with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity (DCNVA). The study enrolled 333 men and women between the ages of 40 and 64 years. According to the company, the VEGA-2 Phase 3 study achieved a primary endpoint in presbyopia.^2,3

The ongoing VEGA-3 trial is a randomized, double-masked, placebo-controlled, multi-center, trial evaluating phentolamine ophthalmic solution 0.75% in 545 participants with presbyopia. Participants are randomized 3:2 to receive 1 drop of phentolamine ophthalmic solution 0.75% or placebo each evening. The primary endpoint is the percentage of participants with 15-letter improvement in photopic binocular DCNVA on the 8th day following their first visit.¹

Phentolamine ophthalmic solution 0.75% is a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, by blocking the alpha-1 receptors found on the radial iris dilator muscles. Aside for the treatment of presbyopia, it is also being developed for dim (mesopic) light vision disturbances after keratorefractive surgery.

Ocuphire stated it anticipates using data obtained from the VEGA-3 trial to support a supplemental New Drug Application with the U.S. Food and Drug Administration.¹

Top-line data from the phase 3 VEGA-3 trial are expected in 2025.¹

References:

1. Ocuphire Pharma Initiates VEGA-3 Phase 3 Trial Evaluating Phentolamine Ophthalmic Solution 0.75% for Presbyopia. Press Release; September 5, 2024. Accessed September 5, 2024. https://www.globenewswire.com/news-release/2024/09/05/2941295/0/en/Ocuphire-Pharma-Initiates-VEGA-3-Phase-3-Trial-Evaluating-Phentolamine-Ophthalmic-Solution-0-75-for-Presbyopia.html

2. VEGA-2 Pivotal Phase 3 Trial of Phentolamine Ophthalmic Solution 0.75% in Presbyopia. Ocuphire Pharma. Accessed September 5, 2024. https://www.ocuphire.com/clinical-trials/vega-2-pivotal-phase-3-trial-of-nyxol-in-presbyopia

3. Ocuphire Pharma Announces Financial Results for Fourth Quarter and Full Year 2023 and Provides Corporate Update. Ocuphire Pharma. Accessed September 5, 2024. https://www.ocuphire.com/news-media/press-releases/detail/431/ocuphire-pharma-announces-financial-results-for-fourth