Ocuphire Pharma Starts VEGA-3 Phase 3 Trial for Phentolamine Ophthalmic Solution 0.75% in Presbyopia

Ocuphire Pharma, Inc., a clinical-stage ophthalmic biopharmaceutical company, has commenced the VEGA-3 Phase 3 clinical trial to evaluate Phentolamine Ophthalmic Solution 0.75% for treating presbyopia. Presbyopia, a common age-related condition that impairs the ability to focus on close objects, typically becomes apparent in individuals in their early to mid-40s, leading many to rely on reading glasses or bifocals. Ocuphire aims to develop a non-invasive, convenient solution to address this issue.

Phentolamine Ophthalmic Solution 0.75% is being designed to offer a safe, long-lasting, and effective alternative for restoring near vision and improving overall visual performance in people with presbyopia. According to George Magrath, M.D., M.B.A., M.S., Ocuphire’s Chief Executive Officer, the commencement of the VEGA-3 trial builds on previous positive results, showing rapid onset, favorable safety, and sustained effect.

Ocuphire plans to utilize the data from the VEGA-3 trial, which will assess the efficacy and safety of Phentolamine Ophthalmic Solution 0.75%, to support a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA). Additionally, the company is making progress in its LYNX-2 trial, with top-line data expected in the first quarter of 2025 if enrollment progresses as anticipated.

The VEGA-3 Phase 3 trial involves 545 participants with presbyopia and is a randomized, double-masked, placebo-controlled, multi-center study. Participants are divided in a 3:2 ratio to receive either Phentolamine Ophthalmic Solution 0.75% or a placebo each evening. The primary endpoint is the proportion of participants achieving a 15-letter improvement in photopic binocular distance-corrected near visual acuity (DCNVA) on the eighth day after their initial visit. This improvement is compared to each participant's baseline value. The study will also collect chronic safety data over 48 weeks. Recruitment will occur at up to 40 sites across the U.S.

The LYNX-2 Phase 3 trial is another significant study for Ocuphire. This randomized, double-masked, placebo-controlled trial evaluates the safety and efficacy of Phentolamine Ophthalmic Solution 0.75% for patients who have undergone keratorefractive surgery and experience visual disturbances such as glare, halos, or starbursts under low light conditions. The trial, conducted under a Special Protocol Assessment (SPA) with the FDA, aims to enroll 200 participants. The primary endpoint is a gain of 3 lines 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.

Currently, there are no FDA-approved treatments for visual disturbances under low light conditions. Phentolamine Ophthalmic Solution 0.75% offers a potential treatment option that reduces pupil size without the risk of retinal tears or detachment associated with other treatments, thereby improving patients’ ability to see and function in low light following keratorefractive surgery.

Ocuphire is overseeing the management of both the VEGA-3 and LYNX-2 trials. Under a License Agreement, Ocuphire’s partner will cover budgeted costs related to the development of Phentolamine Ophthalmic Solution 0.75% through FDA approval and share costs above a certain threshold.

Phentolamine Ophthalmic Solution 0.75% is a late-stage product candidate from Ocuphire, designed to reduce pupil size by blocking alpha-1 receptors on the iris dilator muscles. It is being developed for both presbyopia and visual disturbances under dim light conditions after keratorefractive surgery, with Phase 2 and 3 trials achieving their primary endpoints.

Presbyopia affects over 2 billion people globally, leading to blurred near vision, difficulty seeing in dim light, and eye strain. Similarly, dim light visual disturbances are characterized by peripheral corneal imperfections causing unfocused light when the pupil dilates in low light, resulting in decreased visual acuity and issues like glare and halos.

Ocuphire Pharma focuses on developing therapies for retinal and refractive eye disorders. Its lead product candidate, APX3330, targets diabetic retinopathy, while Phentolamine Ophthalmic Solution 0.75% is being developed for presbyopia and dim light visual disturbances.

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