Opus Genetics' Presbyopia Drop Meets Primary Endpoint in VEGA-3 Phase 3 Trial

Opus Genetics announced positive topline results from VEGA-3, its second pivotal phase 3 trial evaluating phentolamine ophthalmic solution 0.75% for the treatment of presbyopia. The VEGA-3 trial met its primary endpoint, with a statistically significant 27.2% of participants treated with phentolamine ophthalmic solution 0.75% achieving a ≥15-letter improvement in binocular distance-corrected near visual acuity (DCNVA), with less than a 5-letter loss in binocular best-corrected distance visual acuity (BCDVA) at 12 hours post-dose on day 8, compared to 11.5% of patients on placebo (P<0.0001). The trial also met key secondary efficacy endpoints, reinforcing the benefit observed.

“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,” George Magrath, MD, CEO of Opus Genetics, said in a company news release. “The positive results from both our phase 3 VEGA-2 and VEGA-3 trials support the submission of an application to the US FDA, which we plan to file in the second half of 2025. I want to thank the participants and clinical teams who participated in VEGA-3 and who have helped us bring phentolamine ophthalmic solution 0.75% to this point in development.”

“These findings provide further validation of phentolamine ophthalmic solution 0.75% as a differentiated approach to managing presbyopia, reflected by its ability to improve near vision while preserving distance vision without compromising low contrast vision,” said Jay Pepose, MD, PhD, chief medical advisor of Opus Genetics.