Taiwan-based Formosa Pharmaceuticals announced that the company has entered into a licensing agreement with Eyenovia, Inc., whereby Eyenovia obtains exclusive U.S. rights for the commercialization of APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) for the treatment of inflammation and pain following ocular surgery. APP13007 is currently under review by the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) date of March 4, 2024.
The total deal package, including upfront payment and development and sales milestones, has a value of $86 million dollars, with additional considerations throughout the term of the agreement.
APP13007’s active ingredient is the superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma’s proprietary APNT nanoparticle formulation platform.
The novel formulation enables a convenient and straightforward dosing regimen (twice daily for 14 days) while providing rapid and sustained relief of inflammation and pain, which in phase 3 trials proved statistically and clinically superior to its matching placebo (p<0.001). If approved, APP13007 will enter a $1.3 billion dollar market for topical ophthalmic steroids and steroid combinations, driven by an estimated seven million ocular surgeries annually in the U.S.
“Formosa Pharma enters this partnership with Eyenovia with great enthusiasm. We are excited about Eyenovia’s bold and creative marketing strategies, and as a result are confident that APP13007 will realize its potential in providing a formidable choice for ophthalmologists and patients recovering from ocular surgery,” said Erick Co, president and CEO of Formosa Pharmaceuticals. “The complementarity of each company’s products, as well as corporate strategies, lays the foundation for a long-term and rewarding alliance benefiting our stakeholders.”
“We also acknowledge and thank our development colleagues at AimMax Therapeutics, for their expert guidance and enabling the program’s progress,” Dr. Co added.
“We are pleased to have entered into this agreement with our development partner, Formosa Pharmaceuticals, to acquire the U.S. commercial rights to APP13007. If approved, APP13007 would be an attractive new treatment option for the aftereffects of ocular surgery, most notably inflammation and pain,” stated Michael Rowe, CEO of Eyenovia. “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. Alongside our mydriasis product, Mydcombi, we can bring synergistic value to ophthalmic surgeons and their patients through the use of MydCombi™ for pre-operative dilation and APP13007 post-operatively, both supported by a single dedicated sales force.”