Opus Genetics (Nasdaq: IRD) has achieved significant milestones in the development of its Phentolamine Ophthalmic Solution 0.75%, securing FDA Fast Track designation for treating night vision impairment in post-surgical patients while making substantial progress in two pivotal Phase 3 trials.
FDA Fast Track Designation Details
The FDA granted Fast Track status to Phentolamine Ophthalmic Solution 0.75% specifically for treating significant chronic night driving impairment in keratorefractive patients experiencing reduced mesopic vision and photic phenomena. This designation acknowledges the serious unmet medical need and provides benefits including more frequent FDA interactions, potential Priority Review, and rolling review of the New Drug Application (NDA).
Advanced Progress in Clinical Trials
The VEGA-3 trial, focusing on presbyopia treatment, has completed enrollment with 545 participants across 39 U.S. research sites. This randomized, double-masked, placebo-controlled study aims to evaluate the solution's efficacy in improving near vision without compromising nighttime distance vision. The primary endpoint measures the percentage of participants achieving a 15-letter improvement in photopic binocular distance-corrected near visual acuity by day eight.
The LYNX-2 Phase 3 trial, now 95% enrolled toward its 200-subject target, evaluates the treatment in patients with decreased visual acuity following keratorefractive surgery. Operating under a Special Protocol Assessment with the FDA, the study's primary endpoint seeks a three-line improvement in distance vision under low light conditions after 15 days of treatment.
Mechanism of Action and Market Potential
"Presbyopia affects millions of people and represents a daily challenge that can diminish independence and quality of life," stated Dr. Jay Pepose, Chief Medical Advisor at Opus Genetics. The company's solution works by selectively blocking alpha-1 receptors on radial iris dilator muscles, providing pupil size reduction without affecting the ciliary muscle.
The market opportunity is substantial, with an estimated 128 million Americans and over 2 billion people worldwide affected by presbyopia. The condition typically impacts individuals over 40, causing difficulty with near vision tasks such as reading and using digital devices.
Post-Surgical Application
For post-keratorefractive surgery patients, the treatment addresses a common complication where decreased low contrast visual acuity under dim conditions affects night driving and creates visual disturbances such as glare and halos. Currently, no FDA-approved treatments exist for this condition, highlighting the potential significance of Phentolamine Ophthalmic Solution 0.75% in addressing this unmet need.
The company anticipates completing LYNX-2 trial enrollment in the first half of 2025, marking another step toward potentially transforming the management of both presbyopia and post-surgical vision impairment.
