First subjects dosed in phase 3 trial of phentolamine ophthalmic solution for presbyopia
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Key takeaways:
- Phentolamine ophthalmic solution 0.75% will be evaluated in 545 participants with presbyopia.
- Topline data are expected in 2025.
Ocuphire Pharma has dosed the first participants in the VEGA-3 phase 3 clinical trial investigating phentolamine ophthalmic solution 0.75% for the treatment of presbyopia, according to a press release.
The randomized, double-masked, placebo-controlled, multicenter trial will investigate the efficacy and safety of phentolamine ophthalmic solution as a “noninvasive, convenient alternative to traditional corrective measures” for presbyopia in 545 participants. They will be randomly assigned 3:2 to receive phentolamine ophthalmic solution or placebo each evening, with follow-up for 48 weeks. The primary endpoint is the percentage of participants demonstrating a 15-letter improvement in photopic binocular distance corrected near visual acuity 8 days after their first visit, according to the release.
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The data will support a supplemental new drug application to the FDA for phentolamine ophthalmic solution 0.75% for presbyopia, with topline data expected in the first half of 2025.
“Our goal is to provide a safe, long-lasting, effective solution that restores near vision and enhances overall visual performance in people with presbyopia, under both daytime and nighttime conditions,” George Magrath, MD, MBA, MS, CEO of Ocuphire, said in the release. “We are pleased to begin the VEGA-3 trial, building on the positive results generated in our prior presbyopia studies, which have shown a rapid onset of action, favorable safety profile and sustained duration of effect that are promising at this stage.”
In addition, Ocuphire expects topline data from the LYNX-2 phase 3 study, which is evaluating phentolamine ophthalmic solution 0.75% in patients who reported glare, halos or starbursts and demonstrated low contrast visual acuity under mesopic light conditions after keratorefractive surgery, in the first quarter of 2025.
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