Opus Genetics gets Fast Track designation for phentolamine ophthalmic solution

Opus Genetics (IRD) announced completion of enrollment in the VEGA-3 Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% for presbyopia. Opus also announced that enrollment in the LYNX-2 pivotal Phase 3 trial, evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of visual loss in low light conditions associated with keratorefractive surgery, is well-underway with anticipated completion of enrollment in the first half of 2025. In addition, the FDA has granted Fast Track designation for Phentolamine Ophthalmic Solution 0.75% as treatment of significant chronic night driving impairment with concomitant increased risk of motor vehicle accidents and debilitating loss of best spectacle corrected mesopic vision in keratorefractive patients with photic phenomena. Fast track status is designated to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.