Ocuphire’s pupil dilation treatment shows promising Phase III trial results
pharmafile | March 15, 2021 | News story | Sales and Marketing | Ocuphire, eye treatment, nyxol
Ocuphire Pharma’s Nyxol treatment for pharmacologically-induced pupil dilation (mydriasis) has met its primary and secondary endpoints in its Phase III trial.
The treatment was found to show significant efficacy in participants’ pupils more rapidly returning to normal size, after the pupils had been deliberately dilated for eye exams.
The randomised, placebo-controlled MIRA-2 study enrolled 185 participants, and showed that 49% of subjects treated with Nyxol returned to less than 0.2mm of their baseline pupil diameter at 90 minutes, compared to 7% of those administered with a placebo.
As well as this, a clinically meaningful higher number of Nyxol-treated subjects returned to baseline pupil diameter at 60 minutes compared to placebo, and every subsequent time point up to six hours after receiving their dose.
Ocuphire is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercialising therapies for the treatment of several eye disorders.
Mina Sooch, President and CEO of Ocuphire, said: “The successful outcome of this Phase III MIRA-2 FDA registration trial is a major milestone for Ocuphire and we are thrilled to announce these positive and clinically meaningful results.
“Nyxol showed a statistically significant improvement on the primary as well as multiple secondary endpoints, demonstrating its ability to more rapidly return pupil diameter back to normal baselines over multiple timepoints, breadth of iris colors, and dilating agents that work on one or both iris muscles that control pupil size.”
Dr Jay S Pepose PhD, Professor of Clinical Ophthalmology at the Washington University School of Medicine, and Ocuphire Medical Advisory Board member, added: “Nyxol is unique as the only alpha-1/2 antagonist in clinical trials. Nyxol has the potential to address an unmet medical need as there are no commercial treatments currently available for reversal of mydriasis.
“If approved for marketing by the FDA, Nyxol may provide substantial benefit to patients after dilation, and may even increase the compliance with standard of care guidance for dilated examinations during visits to eye care specialists and thereby improve overall eye health.”
Jack Goddard
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