Ocuphire initiates Global License Agreement for Nyxol eye drops across 3 indications

On November 7, 2022, Ocuphire Pharma announced plans to execute an exclusive license agreement with FamyGen Life Sciences, Inc. (Famy) for the development and commercialization of Nyxol for the reversal of mydriasis, presbyopia and night vision disturbances. Together with Viatris Inc., the group plans to bring the eye drop to market in US, Europe, Japan, India, China and additional global markets not yet specified.

“Famy and Ocuphire have been engaging for several months, in a collaborative spirit, to conclude this agreement. This partnership provides a clear pathway to completing development and regulatory activities and executing a successful US and global commercial launch of Nyxol through Viatris,” said Mina Sooch, MBA, founder and CEO of Ocuphire, in a press release.

The license agreement, under which Ocuphire will receive $35 million upfront, requires Famy to fund Nyxol development—including clinical, manufacturing, and regulatory activities—through FDA approval for all indications, including Nyxol+Low-Dose Pilocarpine.

Following the NDA submission for the indication of reversal of mydriasis, which is expected this quarter, Ocuphire could receive a $10 million milestone payment upon FDA approval in 2023. Additional regulatory milestones for presbyopia and night vision disturbances indications may also result in a payout. Furthermore, Ocuphire is expected to receive tiered double-digit royalties on global net sales though 2040; the company is also eligible for sales milestone payments dependent on annual sales thresholds.

In addition to funding the development of Nyxol in the US, Famy is responsible for development in global markets.

“With its strategic commitment to ophthalmics and its global commercial infrastructure, we believe Viatris provides a great opportunity for all of the Nyxol indications to realize their full commercial potential in their respective markets,” Sooch continued. “In addition, the upfront payment and development funding provided by this transaction markedly improve our cash position into 2025, allowing us to expedite the registration trials for presbyopia and night vision disturbances and to execute our late-stage development strategy for the APX3330 retina program.”