Ocuphire Pharma Begins VEGA-3 Phase 3 Trial for Presbyopia Treatment

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. This study focuses on evaluating the efficacy and safety of Phentolamine Ophthalmic Solution 0.75% as a treatment for presbyopia, a common age-related condition that hampers near vision. The VEGA-3 trial has successfully dosed its initial participants.

Presbyopia typically affects individuals in their early to mid-40s, causing difficulties in focusing on close objects and often leading to the widespread use of reading glasses. Ocuphire aims to offer a non-invasive and convenient alternative to these traditional corrective measures through Phentolamine Ophthalmic Solution 0.75%.

George Magrath, M.D., M.B.A., M.S., CEO of Ocuphire, expressed the company's commitment to providing a safe and effective solution for restoring near vision in presbyopia patients. The ongoing VEGA-3 trial builds on promising results from previous studies, which highlighted the rapid onset, favorable safety profile, and sustained effectiveness of Phentolamine Ophthalmic Solution 0.75%.

The VEGA-3 trial is a randomized, double-masked, placebo-controlled study involving 545 participants with presbyopia. Participants are assigned to receive either the Phentolamine solution or a placebo each evening, with the primary endpoint being a 15-letter improvement in photopic binocular distance-corrected near visual acuity (DCNVA) by the eighth day. The improvement will be measured against each participant's baseline value, and safety data will be collected over a 48-week period. The trial is being conducted across up to 40 sites in the U.S.

Additionally, Ocuphire is progressing with the LYNX-2 Phase 3 clinical trial, which aims to address visual disturbances under low light conditions following keratorefractive surgery. The LYNX-2 trial is designed to assess the safety and efficacy of Phentolamine Ophthalmic Solution 0.75% in improving low contrast visual acuity and reducing glare, halos, and starbursts experienced by patients. This study is being conducted under a Special Protocol Assessment (SPA) with the FDA and is expected to enroll 200 participants. The primary endpoint is a gain of 3 lines (or 15 letters) of distance vision improvement in low light conditions after 15 days of dosing. Top-line data from this trial are anticipated in the first quarter of 2025.

Phentolamine Ophthalmic Solution 0.75% is recognized for its unique action of reducing pupil size by blocking alpha-1 receptors on the radial iris dilator muscles. This mechanism does not involve the ciliary muscle, reducing the risk of retinal complications associated with other treatments. The solution is being developed for both presbyopia and dim light vision disturbances.

Ocuphire manages both the VEGA-3 and LYNX-2 trials, with a partner covering development costs up to a specified amount. Phentolamine Ophthalmic Solution 0.75% is already approved and marketed by the partner as RYZUMVI™ for treating pharmacologically induced mydriasis.

Presbyopia affects an estimated 128 million Americans and over 2 billion people worldwide, with these numbers expected to rise as the population ages. Patients with presbyopia experience blurred near vision, difficulty seeing in dim light, and eye strain. Similarly, decreased visual acuity under low light conditions (DLD) manifests as peripheral corneal imperfections causing unfocused light and reduced low contrast visual acuity, coupled with symptoms like glare, halos, and starbursts.

Ocuphire Pharma is dedicated to developing innovative therapies for retinal and refractive eye disorders, with its lead product candidate, APX3330, being developed for diabetic retinopathy. The company continues to advance its late-stage product candidate Phentolamine Ophthalmic Solution 0.75%, aiming to provide effective treatment options for presbyopia and DLD.

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