- APP13007, if approved, may have an advantageous profile in dosing frequency and side effects while reducing the inflammation and pain associated with ocular surgery
- Further leverages Eyenovia’s Mydcombi sales force and represents additional near-term potential revenue source
- Eyenovia plans to evaluate novel clobetasol formulations in its proprietary Optejet® dispensing platform as a potential treatment for dry eye, estimated to be a $3.6 billion market in the U.S.
Eyenovia, Inc. has secured exclusive U.S. rights from Formosa Pharmaceuticals to distribute and sell APP13007, a clobetasol propionate ophthalmic nanosuspension currently under FDA review for post-ocular surgery inflammation and pain relief. Eyenovia will pay Formosa in cash and shares for signing, FDA approval, and initial sales milestones. This potential treatment offers advantages in dosing frequency and tolerability, addressing the aftereffects of ocular surgery. Eyenovia intends to further explore novel clobetasol formulations for dry eye treatment using its Optejet device. The partnership is seen as a strategic alliance between the two companies, aiming to enhance patient care.
Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis and developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that it has entered into an agreement with Taiwan-based Formosa Pharmaceuticals (TWO:6838) whereby Eyenovia has acquired the exclusive U.S. rights to distribute and sell APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%), which is currently under review by the U.S. Food and Drug Administration (FDA). The agency has assigned a Prescription Drug User Fee Act (PDUFA) action date for APP13007 of March 4, 2024.
Per the terms of the agreement, 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 and the transfer of the NDA to Eyenovia, and following the first commercial sale of APP13007. Additionally, 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 (2x/day versus 4x/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.
Want to publish your own articles on DistilINFO Publications?
Send us an email, we will get in touch with you.
“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, chief executive officer 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 additional 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.”
“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. This agreement ushers in an exciting new chapter in Eyenovia’s emergence as a commercial ophthalmic company,” Mr. Rowe concluded.
“Formosa Pharma enters this partnership with Eyenovia with great enthusiasm. The complementarity of each company’s products, as well as corporate strategies, lay the foundation for a long-term and rewarding alliance for all stakeholders,” said Erick Co, President and CEO of Formosa Pharmaceuticals. “With Eyenovia’s bold and creative marketing strategies, we are confident that APP13007 will realize its potential in providing a formidable choice for ophthalmologists and patients for the relief of inflammation and pain following ocular surgery.”
“Given my focus on new ophthalmic technologies, having worked on the clinical development of both Eyenovia’s Mydcombi and Formosa’s clobetasol ophthalmic nanosuspension, I can speak directly to the significant advancements that each represents in its respective indication,” stated William J. Flynn, M.D., Research Director of R & R Eye Research in San Antonio. “I look forward to the potential of prescribing APP13007 in the first half of next year and intend to incorporate it and Mydcombi into my practice as soon as possible.”
APP13007 is the first product developed using Formosa’s proprietary APNT™ nanoparticle formulation platform. Formosa’s APNT™ platform reduces an active pharmaceutical ingredient’s particle size with high uniformity and purity, thereby allowing penetration to relevant compartments in the eye, and ultimately enhancing bioavailability.
Source: Biospace