Under the agreement, US-based Eyenovia has obtained the exclusive US rights to distribute and sell APP13007 in a deal worth up to $86m, with additional payments expected over the term of the agreement
Eyenovia acquires the US commercial rights to APP13007 from Formosa. (Credit: Kalea Jerielle on Unsplash)
Taiwan-based Formosa Pharmaceuticals has signed a licensing agreement with Eyenovia under which the latter will gain exclusive rights to commercialise APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) in the US for the treatment of pain and inflammation post ocular surgery.
As per the terms of the deal, Eyenovia will make payments to Formosa Pharmaceuticals in cash and shares of its common stock upon the signing of the agreement, upon FDA approval, transfer of the New Drug Application (NDA), and following the first commercial sale of APP13007.
Additionally, the Taiwanese pharma company will be eligible for payments related to the achievement of sales milestones by Eyenovia.
After including upfront payment and development and sales milestones, the total value of the arrangement is $86m, with additional payments expected to be made to the Taiwanese firm over the term of the agreement.
Formosa Pharmaceuticals president and CEO Erick Co said: “We are excited about Eyenovia’s bold and creative marketing strategies, and as a result are confident that APP13007 will realise its potential in providing a formidable choice for ophthalmologists and patients recovering from ocular surgery.
“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.”
APP13007 is the first product developed using the proprietary APNT nanoparticle formulation platform of Formosa Pharmaceuticals. It features clobetasol propionate, an ultra-potent corticosteroid, as its active component.
The formulation is said to allow an easy and simple dosing regimen to deliver rapid and sustained relief of inflammation and pain.
The investigational therapy has been found statistically and clinically superior to its matching placebo in Phase 3 trials.
APP13007 is presently under review by the US Food and Drug Administration (FDA). It has also received a Prescription Drug User Fee Act (PDUFA) date of 4 March 2024.
Eyenovia CEO Michael Rowe said: “If approved, APP13007 would be an attractive new treatment option for the aftereffects of ocular surgery, most notably inflammation and pain.
“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.”
Eyenovia is also focused on commercialising Mydcombi for mydriasis and the ongoing late-stage development of drugs in the Optejet device to treat presbyopia and myopia progression.