Eyenovia acquires US commercial rights for APP13007 from Formosa
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Key takeaways:
- Eyenovia obtained the rights to distribute and sell APP13007 in the U.S.
- The Prescription Drug User Fee Act date for APP13007 is March 4, 2024.
Eyenovia has acquired the exclusive U.S. rights to distribute and sell APP13007, a potential treatment for inflammation and pain after ocular surgery, under an agreement with Formosa Pharmaceuticals, according to a press release.
Eyenovia will make single-digit million-dollar payments to Formosa in cash and shares of Eyenovia common stock upon the signing of the agreement, upon FDA approval of APP13007 (clobetasol propionate ophthalmic nanosuspension 0.05%) and transfer of the new drug application to Eyenovia, and after the first commercial sale of APP13007, the release said. Formosa will also be eligible for sales milestone payments.
APP13007 previously demonstrated positive results in the reduction of inflammation and pain after cataract surgery compared with placebo in a phase 3 clinical study.
APP13007 is under review by the FDA and has a Prescription Drug User Fee Act date of March 4, 2024.
“If approved, APP13007 would be an attractive new treatment option for the aftereffects of ocular surgery, most notably inflammation and pain,” Michael Rowe, CEO of Eyenovia, said in the release. “The acquisition of APP13007 is an opportunistic addition to our product portfolio and a new potential source of near-term revenue at what we believe are very favorable terms for both parties.”
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