Opus Genetics (IRD) said Thursday that its second pivotal phase 3 trial evaluating Phentolamine Ophthalmic Solution 0.75% for presbyopia met its primary endpoint.
The randomized, double-masked, placebo-controlled study enrolled 545 participants across 40 US sites. Patients received either the treatment or a placebo once daily in the evening. The results showed that 27.2% of patients achieved a 15-letter or more improvement in near visual acuity without significant loss in distance vision, compared with 11.5% in the placebo group.
The trial also met its secondary endpoints, with no serious adverse events or signs of tachyphylaxis over six weeks. The safety profile was consistent with earlier studies, the company said.
Opus CEO George Magrath said the company plans to file an application with the FDA in the second half of the year.
Opus Genetics shares were up over 11% in recent premarket activity on Thursday.
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