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UPDATE – Ocuphire Pharma Initiates VEGA-3 Phase 3 Trial Evaluating Phentolamine Ophthalmic Solution 0.75% for Presbyopia
OCUPOcuphire Pharma(OCUP) GlobeNewswire News Room·2024-09-06 00:43

Core Insights - Ocuphire Pharma, Inc. is advancing its clinical trials for Phentolamine Ophthalmic Solution 0.75%, targeting presbyopia and visual disturbances under low light conditions [1][3][6] - The VEGA-3 Phase 3 trial has commenced, with top-line data expected in the first half of 2025, while the LYNX-2 Phase 3 trial is also ongoing, with data anticipated in the first quarter of 2025 [1][4][5] Company Overview - Ocuphire Pharma is a clinical-stage ophthalmic biopharmaceutical company focused on developing therapies for retinal and refractive eye disorders [11] - The company's lead product candidate, APX3330, is in development for diabetic retinopathy, alongside Phentolamine Ophthalmic Solution 0.75% for presbyopia and dim light vision disturbances [11] Product Development - Phentolamine Ophthalmic Solution 0.75% is designed as a non-invasive alternative to traditional corrective measures for presbyopia, which affects a significant portion of the aging population [2][9] - The solution works by reducing pupil size without the risks associated with other treatments, potentially improving visual function in low light conditions [6][8] Clinical Trials - The VEGA-3 trial involves 545 participants and aims to evaluate the efficacy of Phentolamine in improving near visual acuity [4] - The LYNX-2 trial is focused on participants who have undergone keratorefractive surgery and are experiencing visual disturbances, with a target enrollment of 200 participants [5] Market Potential - Presbyopia affects an estimated 128 million Americans and over 2 billion people globally, indicating a substantial market opportunity for effective treatments [9] - Currently, there are no FDA-approved treatments for visual disturbances under low light conditions, positioning Phentolamine as a potential first-in-class option [6]