FDA agrees to LYNX-2 trial of phentolamine ophthalmic solution for poor night vision
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Ocuphire Pharma has received agreement from the FDA under a special protocol assessment for its LYNX-2 phase 3 trial, a study of phentolamine ophthalmic solution for treatment of reduced visual acuity under low light conditions.
According to a company press release, the FDA agreed that the clinical trial protocol and planned statistical analysis could adequately address objectives supporting regulatory submission and future marketing application.
“The SPA agreement with the FDA provides a clear regulatory path for phentolamine ophthalmic solution in patients with poor night vision after keratorefractive surgery,” Ocuphire CEO George Magrath, MD, MBA, MS, said in the release. “Preparations for the LYNX-2 phase 3 trial have begun, and we anticipate patient enrollment to begin in the first quarter of 2024.”
The multicenter, randomized, double-masked, placebo-controlled trial will investigate the safety and efficacy of phentolamine ophthalmic solution in up to 200 patients in the U.S. The primary outcome of interest is a gain of at least three lines, or 15 letters, of distance vision improvement on a low contrast chart in dim light conditions after 15 days of treatment.
“Currently, there are no FDA-approved pharmacologic therapies to treat this condition that is routinely presented in our clinics,” Marguerite McDonald, MD, FACS, clinical professor of ophthalmology at NYU’s Langone Medical Center and Tulane University Health Sciences Center, said in the release. “A distinct attribute of phentolamine ophthalmic solution compared to other miotics in the class is that it does not make the pupil too small, which can decrease contrast and degrade vision.”
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