Following the FDA approval and transfer of the New Drug Application (NDA) to Eyenovia, Formosa will be eligible to receive a single-digit million-dollar payment, as per Eyenovia’s 16 August press release. Formosa will receive additional milestone-based payments totalling $86m, including the upfront payment.
Eyenovia plans to incorporate the drug with its drug delivery device Optejet for a drug-device therapeutic, with the company’s CEO Michael Rowe stating: “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.”
Eyenovia plans to market both products for surgical use. “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,” said Rowe.
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