The company completed enrollment ahead of schedule in a second Phase 3 FDA registration trial for Nyxol in RM with top-line results expected by the end of the first quarter.
Ocuphire Pharma Inc. today announced that it has completed enrollment in MIRA-3, the second Phase 3 FDA registration trial evaluating the safety and efficacy of Nyxol eye drops to reverse pharmacologically-induced mydriasis (RM).
According to Mina Sooch, MBA, CEO and founder, Ocuphire Pharma, the company has surpassed its target of 330 with 368 patients in the MIRA-3 trial and accomplished this milestone ahead of schedule in less than 3 months.
“This trial is part of the comprehensive MIRA clinical program to support a planned New Drug Application for Nyxol in RM later this year,” Sooch said. “There are no commercially available reversal drops for dilation, and Nyxol’s unique mechanism as an alpha-1 blocker has the potential to address an estimated $500 million RM market by providing therapeutic benefit to patients and utility for physicians in retinal, optometry and ophthalmology practices.”
Sooch also lauded the efforts of clinical investigators, their site staffs, and the study subjects for their participation in the company’s clinical trial.
“Separately, we continue to share new safety and efficacy data from our ongoing Nyxol and APX3330 studies with the ophthalmic community and look forward to our presentations at the two upcoming medical conferences,” Sooch concluded.
Enrollment has been completed in just 11 weeks in the MIRA-3 Phase 3 clinical trial investigating the safety and efficacy of Nyxol eye drops to reverse pharmacologically-induced mydriasis. The study, a randomly assigned, double-masked, placebo-controlled pivotal Phase 3 study recruiting healthy subjects aged 12 and older, has exceeded its target enrollment of 330 subjects. A total of 368 patients were successfully enrolled in MIRA-3 across 16 centers in the United States even with the challenging circumstances related to the COVID-19 pandemic.
Oculos Development Services, a clinical research organization, led the execution of the MIRA-3 trial. Top-line results are expected to read out soon in early 2022 (around the end of this quarter). If successful, Ocuphire anticipates submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Nyxol for RM in late 2022.