OCUP - Ocuphire completes registrational study for lead asset ahead of schedule

Ocuphire Pharma (OCUP +3.4%) announced an earlier-than-expected completion in the recruitment of its second Phase 3 registration trial for Nyxol eye drops, which is designed to assess the alpha-1 blocker in the reversal of pharmacologically induced mydriasis (RM). Topline data from the study are expected in early 2022, around the end of this quarter, the company said on Tuesday, indicating a potential submission of a New Drug Application (NDA) later this year. A once-daily, eye drop formulation of phentolamine mesylate, Nyxol is Ocuphire’s lead product candidate, and it is targeted at an estimated $500M market in RM where there are no commercially available reversal drops for dilation.  “We are delighted to have surpassed our enrollment target of 330 with 368 patients in the MIRA-3 trial and accomplished this milestone ahead of schedule in less than 3 months,” CEO Mina Sooch noted. Last month, Ocuphire (NASDAQ:OCUP) announced its plans to commercially launch Nyxol

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Ocuphire completes registrational study for lead asset ahead of schedule