Opus Genetics Announces Positive Phase III Results for Phentolamine 0.75% in Presbyopia
Opus Genetics has released top-line results from its VEGA‑3 Phase III trial of phentolamine ophthalmic solution 0.75% as a potential treatment for presbyopia.
Trial Design & Efficacy Highlights
The VEGA-3 study was a multicenter, randomized, double-masked, placebo-controlled Phase III clinical trial that enrolled 545 participants across 40 sites in the United States. Patients were randomized in a 3:2 ratio to receive either phentolamine ophthalmic solution 0.75% or placebo, administered once daily in the evening. The clinical trial is registered under the identifier NCT06542497.
Primary Endpoint (Day 8, 12 hours post-dose)
• ≥15-letter improvement in binocular distance-corrected near visual acuity (DCNVA) with ≤5-letter loss in best-corrected distance visual acuity (BCDVA)
• Result: 27.2% of phentolamine patients achieved the endpoint vs 11.5% with placebo (p < 0.0001)
Early Onset of Efficacy (Day 1, 1-hour post-dose)
• 20.6% of phentolamine-treated patients achieved ≥15-letter gain in DCNVA vs 6.1% with placebo (p = 0.0002)
• No evidence of tachyphylaxis was observed after 6 weeks compared to day 8 results
• Long-term safety monitoring will continue for 48 weeks
Mechanism & Regulatory Plans
Phentolamine Ophthalmic Solution 0.75% is a non-selective alpha-1 and alpha-2 adrenergic antagonist that reduces pupil size, administered as an eye drop. It is currently being evaluated in two Phase III programs under:
• LYNX—for presbyopia with dim (mesopic) light vision disturbances post-keratorefractive surgery
• VEGA—for presbyopia
Data from VEGA‑2 and VEGA‑3 will support a planned FDA application in the second half of 2025.
Leadership Commentary
George Magrath, MD, CEO of Opus Genetics, said:
“The results of the VEGA‑3 trial reinforce our belief that Phentolamine Ophthalmic Solution 0.75% could offer an option to improve near vision for millions of adults affected by presbyopia.”
