Ocuphire Pharma announced that the VEGA-3 Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% for presbyopia has dosed its first participants. Phentolamine Ophthalmic Solution 0.75% is being developed to provide a non-invasive, convenient alternative to traditional corrective measures, the company said in a press release. 

Ocuphire says it anticipates using data obtained from the VEGA-3 trial demonstrating the efficacy and safety of Phentolamine Ophthalmic Solution 0.75% as a potential treatment for presbyopia to support a supplemental new drug application with the FDA.

According to the company, VEGA-3 is a randomized, double-masked, placebo-controlled, multi-center, Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% in 545 participants with presbyopia. Participants are randomized 3:2 to receive one 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 distance-corrected near visual acuity (DCNVA) on the eighth day following their first visit. The improvement in binocular DCNVA for each participant will be relative to their own baseline value. Participants will be followed a total of 48 weeks to collect chronic safety data. Recruitment will take place at up to 40 investigational sites in the United States. 

In addition to the VEGA-3 Phase 3 clinical trial, the company is enrolling patients for the LYNX-2 Phase 3 trial that is designed to evaluate the safety and efficacy of Phentolamine Ophthalmic Solution 0.75% compared to placebo in participants who underwent keratorefractive surgery and then reported glare, halos or starbursts and demonstrated low contrast visual acuity under mesopic (low) light conditions. According to Ocuphire, the LYNX-2 trial is being conducted under conditions of a Special Protocol Assessment (SPA) with the FDA. The trial is expected to enroll 200 participants. The primary endpoint, agreed with the FDA under the SPA, will be a gain of 3 lines (or 15 letters) or more of distance vision improvement on a low contrast chart in low light conditions after 15 days of dosing. Top-line data are expected in the first quarter of 2025. 

With a mechanism of action that moderately reduces pupil size without the increased risks of retinal tears or detachment associated with parasympathomimetic miotics that engage the ciliary muscle, the company says Phentolamine Ophthalmic Solution 0.75% eyedrops have the potential to be a treatment option that could improve patients’ ability to see and function in low light following keratorefractive surgery.