Ocuphire announces beginning of Phase III trial of treatment for reversal of mydriasis (RM)

pharmafile | November 24, 2021 | News story | Research and Development  

Ocuphire Pharma, a clinical-stage ophthalmic biopharmaceutical company, announced that the first subjects have been enrolled in the MIRA-3 Phase III pivotal trial evluating Nyxol® Eye Drops in the reversal of pharmacologically-induced mydriasis (dilation of the pupil).

Top-line results from the trial are expected in early 2022, as six sites are enrolling subjects within days of activation and ten more sites are expected to start screening shortly.

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, randomised, placebo-controlled study of the safety and efficacy profile of Nyxol, to reverse pharmacologically-induced mydriasis in healthy subjects.

Mina Sooch, President and CEO of Ocuphire Pharma, said: “The safety and efficacy of Nyxol for reversal of mydriasis have been demonstrated in our prior MIRA-1 Phase 2b and MIRA-2 Phase III 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.”

Ocuphire is focused on the development and commercialisation of therapies for the treatment of numerous eye disorders. The company’s pipeline currently consists of two small-molecule product candidates targeting front and back of the eye indications.

Lina Adams

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