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New exclusive license agreement gives Ocuphire rights to develop, commercialize Nyxol

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Ocuphire Pharma has entered into a global license agreement with FamyGen Life Sciences (Famy) for the exclusive rights to develop and commercialize Nyxol [NICKS-saul] eye drops.

Wait a second … wasn’t Famy just purchased?

It was! The ophthalmic drug development-focused company was acquired—along with Oyster Point Pharma—by Viatris in a deal worth an estimated $700 to 750 million. (via)

Remind me about Nyxol.

Nyxol (phentolamine ophthalmic solution) is a preservative-free eye drop designed to be administered once a day to reduce pupil dilation in patients with three indications: dim light vision disturbances, presbyopia, and reversal of mydriasis.

It was granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) by the FDA for a New Drug Application (NDA) in September 2022. (via)

Tell me more.

Ocuphire will have the exclusive rights to Nyxol across global markets including the U.S., Europe, Japan, India, and China. Famy will continue funding the development of Nyxol through FDA approvals, as well as all activities mandated for FDA approvals of all three Nyxol indications. It will also take on development of Nyxol in the non-U.S. markets.

What will this mean for Ocuphire?

A pending Q4 new drug application (NDA) submission for reversal of mydriasis has the potential for Ocuphrie to receive a $10 million milestone payment following FDA approval in 2023 as well as additional regulatory milestones for presbyopia and NVD. (via)