Ocuphire Pharma has submitted an NDA for phentolamine ophthalmic solution 0.75% (Nyxol) for the reversal of pharmacologically induced mydriasis produced by adrenergic agonist (eg, phenylephrine) or parasympatholytic (eg, tropicamide) agents, or a combination thereof.
What is Nyxol?
It’s a proprietary, preservative-free, investigational eye drop formulation of phentolamine mesylate designed to reduce pupil size by inhibiting contraction of the iris dilator muscle.
How quickly does this reversal work?
Studies show that dilated eyes return to their baseline pupil diameter as early as 60 to 90 minutes.
When will we hear more?
No word on the PDUFA date yet, but likely by the end of 2023. (via)