Formosa Pharmaceuticals Announces Licensing Agreement with Eyenovia, Inc., for the Commercialization of APP13007 for the Treatment of Inflammation and Pain Following Ocular Surgery

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Formosa Pharmaceuticals (6838.TWO) has entered into a licensing agreement with Eyenovia, Inc. (NASDAQ: EYEN) for the exclusive U.S. rights to commercialize APP13007, a treatment for inflammation and pain following ocular surgery. The deal is worth $86 million and includes upfront payment, development and sales milestones. APP13007 is currently under FDA review and has a PDUFA date of March 4, 2024. If approved, it will enter a $1.3 billion market for topical ophthalmic steroids and steroid combinations.

TAIPEI, Aug. 16, 2023 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TWO) announced today that the company has entered into a licensing agreement with Eyenovia, Inc. ("Eyenovia", NASDAQ: EYEN), 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, 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 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."

About Formosa Pharmaceuticals, Inc.

Formosa Pharmaceuticals, Inc. (6838.TWO) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology.  The company's proprietary nanoparticle formulation technology (APNT™), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration.  Resulting formulations have high uniformity, purity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in delivery and penetration to target tissues.  For more details about Formosa Pharma and APNT™, visit www.formosapharma.com.

About Eyenovia, Inc.

Eyenovia, Inc. (NASDAQ: EYEN) is a commercial stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the commercialization of Mydcombi™ for mydriasis, as well as the ongoing late-stage development of medications in the Optejet^® device for presbyopia and myopia progression. For more information, visit Eyenovia.com.

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SOURCE Formosa Pharmaceuticals Inc.

FAQ

What is the licensing agreement between Formosa Pharmaceuticals and Eyenovia about?

The licensing agreement grants Eyenovia exclusive U.S. rights to commercialize APP13007, a treatment for inflammation and pain following ocular surgery, developed by Formosa Pharmaceuticals.

What is the value of the deal between Formosa Pharmaceuticals and Eyenovia?

The deal is worth $86 million, including upfront payment, development and sales milestones.

What is the current status of APP13007?

APP13007 is currently under review by the U.S. Food and Drug Administration (FDA) and has a Prescription Drug User Fee Act (PDUFA) date of March 4, 2024.

What is the market potential for APP13007?

If approved, APP13007 will enter a $1.3 billion market for topical ophthalmic steroids and steroid combinations, driven by an estimated seven million ocular surgeries annually in the U.S.

What is the active ingredient in APP13007?

The active ingredient in APP13007 is clobetasol propionate, a superpotent corticosteroid derived from Formosa Pharma's proprietary APNT™ nanoparticle formulation platform.

What are the advantages of APP13007?

APP13007 offers a convenient and straightforward dosing regimen, providing rapid and sustained relief of inflammation and pain. Phase 3 trials showed it to be statistically and clinically superior to its matching placebo (p<0.001).

What is the significance of the partnership between Formosa Pharmaceuticals and Eyenovia?

The partnership between Formosa Pharmaceuticals and Eyenovia lays the foundation for a long-term and rewarding alliance, benefiting stakeholders of both companies.

What is the role of AimMax Therapeutics in the development of APP13007?

AimMax Therapeutics provided expert guidance and enabled the progress of APP13007's development.

How does Eyenovia view the acquisition of APP13007?

Eyenovia sees the acquisition of APP13007 as an attractive new treatment option for the aftereffects of ocular surgery, with potential near-term revenue and favorable terms for both parties.

What other product does Eyenovia offer alongside APP13007?

Eyenovia offers Mydcombi™, a mydriasis product, which can bring synergistic value to ophthalmic surgeons and their patients when used in combination with APP13007.