Formosa Pharma sends APP13007 eye drug to US

Eyenovia has begun pre-launch activities and is expected to start the commercialisation of APP13007 by late September 2024. Credit: Formosa Pharmaceuticals Inc. Formosa Pharmaceuticals has announced the initial shipment of its ophthalmic product, clobetasol propionate ophthalmic suspension 0.05% (APP13007), to the United States to facilitate its commercialisation.

Developed using Formosa’s APNT nanotechnology platform, APP13007 is the first ophthalmic solution approved by the US Food and Drug Administration (FDA) to feature the highly potent corticosteroid clobetasol propionate. The shipment of APP13007 has been manufactured by Bora Pharmaceuticals Ophthalmic. This product offers a dosing regimen of twice daily, which is more convenient compared to the four doses per day required by other treatments.

Eyenovia, Formosa Pharma’s partner in the US, has started pre-launch activities and is anticipated to begin the commercialisation of APP13007 by late September 2024. In 2023, Eyenovia secured exclusive licensing and commercialisation rights for APP13007 in the US from Formosa Pharmaceuticals through a deal valued at $86 million.

In August 2024, Formosa obtained a drug export licence from Taiwan’s Food and Drug Administration. This licence has facilitated the company to coordinate its first shipment to the US, marking a significant step in its global commercialisation strategy. Foreseeing the demand in the US market, Formosa is also partnering with entities in other regions to prepare for regulatory submissions. The objective is to make APP13007 available in international markets, broadening its reach beyond the US.

Formosa Pharmaceuticals primarily focuses on ophthalmology and oncology. Its APNT technology enhances the dissolution, bioavailability, and stability of active pharmaceutical ingredients, enabling the use of poorly soluble or highly potent drug agents. Dr Erick Co, president and CEO of Formosa Pharma, stated, “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.”