Formosa Pharmaceuticals makes first shipment of APP13007 to US for commercialization

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Formosa Pharmaceuticals Inc. has made its first shipment of APP13007 (clobetasol propionate ophthalmic suspension, 0.05%) to the United States.

According to a news release, the drug is manufactured by Bora Pharmaceuticals Ophthalmic. Formosa Pharma's US partner, Eyenovia, Inc., has initiated the pre-launch activities for APP13007 and is expected to begin commercialization in late September.¹

“This first shipment to Eyenovia for the much-anticipated commercial US launch is an exclamation point on our development of APP13007,” said Eric Co, PhD, president and CEO of Formosa Pharma. “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."

Eyenovia acquired US commercial rights of the drug from Formosa in August, 2023.²

APP13007, according to the company, is the first product developed using Formosa’s proprietary APNT nanoparticle formulation platform. The company noted that its APNT platform reduces an active pharmaceutical ingredient’s particle size with high uniformity and purity, thereby allowing penetration to relevant compartments in the eye, and ultimately enhancing bioavailability.

According to the company, clobetasol is a potent steroid not yet available in ophthalmology that ultimately could have an advantageous profile in dosing frequency (2x/day versus 4x/day for most other post-surgical eye drops) and tolerability while reducing the inflammation and pain associated with ocular surgery.

Almost 7 million ophthalmic surgeries are performed annually in the United States, and the ophthalmic steroid and steroid-combination drug market is valued at $1.3 billion. According to a recent survey conducted by Eyenovia of 100 US ophthalmic surgeons, efficacy and cost were identified as the most important factors when choosing a treatment for postoperative inflammation and pain.

The companies maintain that APP13007 offers a more convenient dosing regimen with its proven efficacy, requiring only twice-daily administration compared to other treatments that require up to four doses per day.

After securing the Drug Export License from Taiwan's Food and Drug Administration (TFDA) in August, Formosa Pharma initiated the coordination of its first US shipment as it moves toward global commercialization.

In addition to meeting demands for the U.S. market, Formosa Pharma is actively working with partners in other regions to prepare for regulatory submissions for APP13007, aiming to supply various international markets in the future.¹

References:

1. Formosa Pharmaceuticals Inc. Formosa Pharmaceuticals Makes First Shipment of APP13007 (Clobetasol Propionate Ophthalmic Suspension, 0.05%) to the United States for Commercialization. Prnewswire.com. Published September 9, 2024. Accessed September 9, 2024. https://www.prnewswire.com/news-releases/formosa-pharmaceuticals-makes-first-shipment-of-app13007-clobetasol-propionate-ophthalmic-suspension-0-05-to-the-united-states-for-commercialization-302241470.html

2. Pharmaceuticals F. Formosa Pharmaceuticals and AimMax Therapeutics Receive FDA Approval for Clobetasol Propionate Ophthalmic Suspension 0.05%, for the Treatment of Post-Operative Inflammation and Pain Following Ocular Surgery. www.prnewswire.com. Accessed March 5, 2024.