Posted by Michael Wonder on 07 Dec 2022
Ocuphire Pharma announces submission of new drug application to FDA for Nyxol eye drops for reversal of mydriasis
6 December 2022 - NDA supported by positive Phase 3 data demonstrating rapid reversal of dilated eyes and favourable safety profile in paediatric and adult subjects.
Ocuphire Pharma today announced the submission of a new drug application to the US FDA for phentolamine ophthalmic solution 0.75% (Nyxol) for the reversal of pharmacologically-induced mydriasis produced by adrenergic agonist (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents, or a combination thereof.
