Formosa Pharmaceuticals Makes First Shipment of APP13007 (Clobetasol Propionate Ophthalmic Suspension, 0.05%) to the United States for Commercialization

PRNewswire 9-Sep-2024 3:00 AM

TAIPEI, Sept. 9, 2024 /PRNewswire/ -- Formosa Pharmaceuticals, Inc. (hereinafter referred to as "Formosa Pharma," 6838.TW) announced the successful first shipment to the United States of its new ophthalmic drug, Clobetasol Propionate Ophthalmic Suspension, 0.05% (APP13007), manufactured by Bora Pharmaceuticals Ophthalmic (hereinafter referred to as "Bora," 6472.TW). Formosa Pharma's U.S. partner, Eyenovia, Inc. (NASDAQ:EYEN), has initiated the pre-launch activities for APP13007 and is expected to begin commercialization in late September.

APP13007, developed through Formosa Pharma's proprietary APNT^® nanotechnology platform, is the first drug approved by the U.S. FDA for ophthalmic use utilizing the super-potent corticosteroid, clobetasol propionate. Almost 7 million ophthalmic surgeries are performed annually in the U.S., and the ophthalmic steroid and steroid-combination drug market is valued at USD $1.3 billion. According to a recent survey conducted by Eyenovia of 100 U.S. ophthalmic surgeons, efficacy and cost were identified as the most important factors when choosing a treatment for postoperative inflammation and pain. 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.

Having recently obtained the Drug Export License from Taiwan's Food and Drug Administration (TFDA) in late August, Formosa Pharma has coordinated its first US shipment, a milestone advancement toward global commercialization.

Dr. Erick Co, President & CEO of Formosa Pharma, said, "This first shipment to Eyenovia for the much-anticipated commercial U.S. 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."

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.

About Formosa Pharmaceuticals, Inc.

Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology.  The company's proprietary nanoparticle formulation technology (APNT^®), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration.  Resulting formulations have high uniformity, purity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in delivery and penetration to target tissues.  For more details about Formosa Pharma and APNT^®, visit www.formosapharma.com.

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SOURCE Formosa Pharmaceuticals Inc.,