Eyenovia has acquired the exclusive licencing and commercialisation rights for APP13007 (clobetasol steroid) in the US, from the Taiwan-based Formosa Pharmaceuticals for $86m.
The deal builds upon the existing partnership between the two companies to develop new eye therapies signed earlier this year.
APP13007 is a 0.05% clobetasol propionate ophthalmic nanosuspension developed using Formosa’s proprietary APNT nanoparticle formulation platform by Formosa and AimMax Therapeutics. It is a twice-daily topical corticosteroid that reduces pain and inflammation following eye surgery.
APP13007 is currently under review by the US Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) action date set for 4 March 2024.
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.”
Earlier this year, Eyenovia’s MydCombi (tropicamide and phenylephrine hydrochloride) was the first eye spray approved by the US FDA for pupil dilation. The spray can be used for pupillary dilation in multiple conditions including cataracts and other eye surgeries.
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.