Ocuphire Pharma Shares Rise After First Patients Enroll in Second Phase 3 Pivotal Trial for Nyxol

Nov 24, 2021 By MarketDepth

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Ocuphire Pharma, Inc. (NASDAQ: OCUP) shares jumped more than 30% after the biopharmaceutical company announced news regarding the first subjects have been enrolled in the MIRA-3 Phase 3 pivotal trial evaluating Nyxol® Eye Drops in the reversal of pharmacologically-induced mydriasis (dilation of the pupil). With 6 sites enrolling subjects within days of activation and 10 more sites expected to start screening shortly, top-line results from the MIRA-3 trial are expected in early 2022 (around the end of the first quarter).

“The safety and efficacy of Nyxol for reversal of mydriasis have been demonstrated in our prior MIRA-1 Phase 2b and MIRA-2 Phase 3 clinical trials. Both of these trials successfully met their primary and multiple secondary endpoints with statistical significance. We know that over half of patients take 6 hours or longer, sometimes 24 hours, to return to their normal pre-dilated pupil size. Our prior data on Nyxol showed that 50% of patients returned to baseline by 90 minutes and 80% by 3 hours. A positive outcome in MIRA-3 comparable to the results achieved in MIRA-2 will position us to submit an NDA for Nyxol for reversal of mydriasis in late 2022. Successful completion of MIRA-3, as well as our planned smaller pediatric safety study, will bring the total number of patients treated with Nyxol to over 500, out of over 900 study subjects.”

Mina Sooch, President and CEO of Ocuphire Pharma

Nyxol is a proprietary, preservative-free, ophthalmic formulation of phentolamine mesylate designed to reduce pupil size by inhibiting or relaxing the iris dilator muscle. MIRA-3 is a multi-center, randomized, parallel-arm, double-masked, placebo-controlled study of the safety and efficacy of Nyxol (0.75% phentolamine ophthalmic solution) to reverse pharmacologically-induced mydriasis in healthy subjects.

“Providing the best care to my patients is my top priority. Therefore, I am eager to adopt treatments that enhance the patient experience. As a retinal specialist, there is simply no substitute for dilation when it comes to disease management and treatment, including chronic intravitreal injections for wet AMD or DME. With the ability to return many patients safely to baseline pupil diameter within an hour or two, Nyxol can provide substantial benefit. We dilate almost all of our patients, and I would be excited to offer Nyxol to my patients following dilation in order to optimize their care.”

David Boyer, M.D., Vitreoretinal Surgeon, Retina-Vitreous Associates Medical Group