US Gets A New Eye Care Solution: Formosa Pharma’s APP13007 Hits The Market

Formosa Pharmaceuticals has successfully dispatched its pioneering ophthalmic product, clobetasol propionate ophthalmic suspension 0.05% (APP13007), to the US, marking a significant step towards its market launch. This innovative drug, created with Formosa's advanced APNT nanotechnology platform, is the first ophthalmic solution approved by the US FDA that incorporates the highly potent corticosteroid clobetasol propionate.

Manufactured by Bora Pharmaceuticals Ophthalmic, APP13007 stands out with its convenient twice-daily dosing schedule, compared to the four doses per day required by other treatments. Eyenovia, Formosa Pharma's partner in the US, has already begun pre-launch preparations and is anticipated to commence the commercialization of APP13007 by the end of September 2024.

In 2023, Eyenovia secured exclusive licensing and commercialization rights for APP13007 in the US through an $86 million agreement with Formosa Pharmaceuticals. By August 2024, Formosa had received a drug export license from Taiwan's Food and Drug Administration, facilitating the first shipment of APP13007 to the US, a crucial move for its global commercialization strategy.

To meet anticipated US demand, Formosa is also working with partners in other regions to prepare for regulatory submissions, aiming to introduce APP13007 to international markets. Formosa Pharmaceuticals, with a focus on ophthalmology and oncology, leverages its APNT technology to improve the dissolution, bioavailability, and stability of active pharmaceutical ingredients, allowing for the effective use of poorly soluble or highly potent drugs.

Formosa Pharma president and CEO Dr Erick Co said in a statement, “This first shipment to Eyenovia for the much-anticipated commercial US launch is an exclamation point on our development of APP13007. We thank all our partners for making this journey with us and are eager to provide this formidable therapy to ocular surgery patients worldwide. We look forward to creating continued value for our stakeholders and shareholders.”