EYECARE Eyenovia Acquires U.S. Commercial Rights to Formosa Pharmaceuticals’ APP13007 for Treatment of Inflammation and Pain After Ocular Surgery By Staff Thursday, August 17, 2023 12:15 AM NEW YORK—Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, announced that it has entered into an agreement with Taiwan-based Formosa Pharmaceuticals whereby Eyenovia has acquired the exclusive U.S. rights to distribute and sell 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). 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. 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, pending 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 and tolerability while reducing the inflammation and pain associated with ocular surgery. “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 after effects 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,” he said. Rowe continued, “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.” “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.”