On February 26, 2025, Opus Genetics, Inc. announced that the FDA granted Fast Track designation for Phentolamine Ophthalmic Solution 0.75%. This designation is for the treatment of significant chronic night driving impairment in keratorefractive patients with reduced mesopic vision and photic phenomena.
The company also reported the completion of enrollment in the VEGA-3 Phase 3 clinical trial, which is evaluating Phentolamine Ophthalmic Solution 0.75% for presbyopia. This trial enrolled 545 participants across 39 investigational sites in the U.S.
Enrollment in the LYNX-2 pivotal Phase 3 trial, evaluating the solution for visual loss in low light conditions after keratorefractive surgery, is well underway and expected to be completed in the first half of 2025. The Fast Track designation offers benefits such as more frequent FDA interactions and eligibility for Priority Review.
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