FDA agrees to LYNX-2 trial of phentolamine ophthalmic solution for poor night vision

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

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