Ocuphire Pharma Inc. (NASDAQ: OCUP) has announced the enrolment of the first participants in its third phase pivotal MIRA-3 study evaluating Nyxol Eye Drops in pharmacologically-induced mydriasis reversal. Six sites already have enrolled participants within days following activation, and ten additional sites are expected to begin screening soon. MIRA-3 study results will be out at the end of Q1 2022.
Safety and efficacy of Nyxol shown in MIRA-1 phase 2b study
CEO Mina Sooch 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 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.”
Nyxol potentially returns patients to baseline pupil diameter in an hour
“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,” commented Retina-Vitreous Associates Medical Group Vitreoretinal Surgeon David Boyer.