Eyenovia (NASDAQ:EYEN) entered an agreement with Taiwan-based Formosa Pharmaceuticals (TWO:6838) to acquire the exclusive U.S. rights to distribute and sell Formosa’s APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%), which is currently under review by the FDA.
The agency has assigned a PDUFA action date for APP13007 of March 4, 2024.
Under the accord, Eyenovia will make single-digit million-dollar payments to Formosa in cash and shares of Eyenovia common stock on signing of the agreement and on FDA approval of APP13007 and the transfer of the NDA to Eyenovia, and following the first commercial sale of APP13007. In addition, Formosa will be eligible for payments related to the attainment of sales milestones by Eyenovia.
Clobetasol is a potent steroid not yet available in ophthalmology that, if approved, may have an advantageous profile in dosing frequency of two times a day versus four times a day for most other post-surgical eye drops, and tolerability, while reducing the inflammation and pain associated with ocular surgery.
It is estimated that there are more than seven million ocular surgeries in the U.S. each year, with topical ocular steroids and steroid combinations currently totaling $1.3-billion in sales.
“We will also be discussing with the FDA the opportunity to develop novel clobetasol formulations as a late-stage asset for use with the Optejet as a potential treatment for dry eye, a market estimated to be worth over $3.6-billion, Michael Rowe, CEO of Eyenovia, said in a statement.
“This agreement ushers in an exciting new chapter in Eyenovia’s emergence as a commercial ophthalmic company,” Mr. Rowe concluded.
