Core Insights - The FDA has granted Fast Track designation for Phentolamine Ophthalmic Solution 0.75% to treat significant chronic night driving impairment in keratorefractive patients with reduced mesopic vision [1][7] - Enrollment in the VEGA-3 Phase 3 trial for presbyopia is complete, while the LYNX-2 trial is expected to complete enrollment in the first half of 2025 [1][2] - Phentolamine Ophthalmic Solution 0.75% aims to provide a non-invasive treatment option for presbyopia and low light vision disturbances post-keratorefractive surgery [2][10] VEGA-3 Phase 3 Program - The VEGA-3 trial involves 545 participants and is designed to assess the improvement in near visual acuity after treatment with Phentolamine Ophthalmic Solution 0.75% [3] - The primary endpoint is a 15-letter improvement in distance-corrected near visual acuity on day eight post-treatment [3] LYNX-2 Phase 3 Program - The LYNX-2 trial targets 200 subjects who have experienced decreased visual acuity in low light conditions after keratorefractive surgery, with over 95% enrollment achieved [5] - The primary endpoint is a gain of 3 lines (or 15 letters) in distance vision improvement on a low contrast chart after 15 days of dosing [5] About Phentolamine Ophthalmic Solution 0.75% - This solution is a non-selective alpha-1 and alpha-2 adrenergic antagonist that reduces pupil size, potentially improving vision in low light conditions [10] - It is being developed as a treatment for both presbyopia and visual disturbances following keratorefractive surgery [10] Company Overview - Opus Genetics is a clinical-stage ophthalmic biotechnology company focused on gene therapies for inherited retinal diseases and other ophthalmic disorders [11] - The company is advancing multiple programs, including Phentolamine Ophthalmic Solution 0.75% and gene therapies targeting specific genetic mutations associated with retinal diseases [11]
Opus Genetics Announces FDA Fast Track and Enrollment Updates for Phentolamine Ophthalmic Solution 0.75% Programs