Eyenovia acquires US commercial rights to APP13007 from Formosa Pharmaceuticals

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Eyenovia Inc. announced it has entered into an agreement with Taiwan-based Formosa Pharmaceuticals to acquire the exclusive US rights to distribute and sell APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%), which is currently under review by the FDA.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date for APP13007 of March 4, 2024.

According to a news release, the agreement calls for Eyenovia to make single-digit, million-dollar payments to Formosa in cash and shares of Eyenovia common stock upon the signing of the deal, upon FDA approval of APP13007 and the transfer of the NDA to Eyenovia, and following the first commercial sale of APP13007.

The company also noted in its news release that Formosa will be eligible for payments related to the attainment of sales milestones by Eyenovia.

According to the company, clobetasol is a potent steroid not yet available in ophthalmology that, if approved, could 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.

APP13007, according to the company, is the first product developed using Formosa’s proprietary APNT nanoparticle formulation platform. The company noted that its 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.

The company also noted in its news release it is estimated that there are more than 7 million ocular surgeries in the US each year with topical ocular steroids and steroid combinations currently totaling $1.3 billion in sales.

Michael Rowe, CEO of Eyenovia, said in the news release his company was pleased with the prospects of working with Formosa Pharmaceuticals to acquire the US 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,” Rowe 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.”

Rowe added that alongside the company’s mydriasis product, Mydcombi, Eyenovia 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,” he added in the news release. “This agreement ushers in an exciting new chapter in Eyenovia’s emergence as a commercial ophthalmic company.”

Erick Co, president and CEO of Formosa Pharmaceuticals, said his company comes into the partnership with plenty of 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,” Co said in the news release. “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.”

William J. Flynn, MD, Research Director of R & R Eye Research in San Antonio, said he has a focus on new ophthalmic technologies, having worked on the clinical development of both Eyenovia’s Mydcombi and Formosa’s clobetasol ophthalmic nanosuspension, and in the news release offered his perspective on what represents in its respective indication.

“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,” he said.