Formosa Pharma supplies ophthalmic drug APP13007 to the USA

Eyenovia has begun preparatory activities and expects to begin commercialization of APP13007 in late September 2024. Image credit: Formosa Pharmaceuticals Inc.

Formosa Pharmaceuticals announced the first shipment of its ophthalmic drug clobetasol propionate eye drops 0.05% (APP13007) to the United States to facilitate commercialization.

Developed using Formosa's APNT nanotechnology platform, the drug is the first U.S. Food and Drug Administration (FDA)-approved ophthalmic solution containing the highly potent corticosteroid clobetasol propionate.

Bora Pharmaceuticals Ophthalmic has manufactured the supply of APP13007, which allows for twice-daily dosing, which is more convenient than the four doses per day required by other treatments.

Eyenovia, Formosa Pharma's US partner, has started preparatory activities and is expected to begin commercializing APP13007 in late September 2024.

In 2023, Eyenovia acquired exclusive licensing and commercialization rights to APP13007 in the United States from Formosa Pharmaceuticals in an $86 million deal.

In August 2024, Formosa received a drug export license from the Taiwanese Food and Drug Administration.

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The license enabled the company to coordinate its first shipment to the United States, an important step in its global commercialization strategy.

In anticipation of demand in the U.S. market, Formosa is also working with partners in other regions to prepare for regulatory submissions.

The goal is to make APP13007 available in international markets and expand its reach beyond the United States.

Formosa Pharmaceuticals focuses primarily on ophthalmology and oncology.

APNT technology improves the dissolution, bioavailability and stability of pharmaceutical active ingredients, enabling the use of poorly soluble or highly potent drugs.

Dr. Erick Co, President and CEO of Formosa Pharma, said: “This first shipment to Eyenovia for the highly anticipated U.S. launch is an exclamation point for our development of APP13007.

“We thank all of our partners who have been on this journey with us and look forward to bringing this outstanding therapy to eye surgery patients worldwide. We look forward to continuing to create value for our stakeholders and shareholders.”