Ocuphire Posts Second Phase III Success In Reversing Pupil Dilation

Nyxol is almost set for an NDA filing for reversal of dilation during eye exams/surgery. The reformulation of phentolamine is also being studied in presbyopia, setting up possible competition with AbbVie’s Vuity.

Eye exam
Ocuphire hopes Nyxol will prove a popular option with eye exam patients • Source: Alamy

Ocuphire Pharma, Inc. reported statistical significance for its eye drop candidate Nyxol in a second pivotal Phase III study in reversal of pharmacologically induced mydriasis (or pupil dilation). Management told investors on a 29 March call that the company anticipates filing the candidate for approval at the US Food and Drug Administration later this year.

There is no approved drug therapy for eye dilation that is induced pharmacologically during a routine eye exam or eye surgery, but Ocuphire presented market research during its call indicating that roughly 80% of patients would request a dilation-reversal drop if one were available and that roughly 70% of ophthalmologists and optometrists would consider using such a product

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