Formosa Pharmaceuticals Launches APP13007 for U.S. Market
Formosa Pharmaceuticals Unveils APP13007 for U.S. Market
Formosa Pharmaceuticals, Inc. has made a significant leap in the realm of ophthalmic medication with the announcement of its successful first shipment of APP13007, also known as Clobetasol Propionate Ophthalmic Suspension, 0.05%. This new drug is prepared for commercialization in the United States. Made by Bora Pharmaceuticals Ophthalmic, this shipment signifies a pivotal moment in Formosa Pharma's journey.
Innovative Drug Development Underpins Commercialization
Using its proprietary APNT® nanotechnology platform, Formosa Pharma has developed APP13007, which has received FDA approval for ophthalmic use. The application of clobetasol propionate—a super-potent corticosteroid—marks a groundbreaking achievement, particularly as nearly 7 million ophthalmic surgeries occur yearly within the United States. Notably, the ophthalmic steroid market is robust, estimated at USD 1.3 billion, highlighting the importance of this development.
Understanding Market Needs
A recent survey conducted by Eyenovia among 100 U.S. ophthalmic surgeons reaffirmed a common insight: efficacy and cost play pivotal roles in selecting treatments for postoperative inflammation and pain. APP13007 has a notably simpler dosing regimen, requiring administration only twice a day, which distinguishes it from other treatments that may necessitate four doses daily.
Significant Milestones on the Path to Global Reach
In late August, Formosa Pharma secured a Drug Export License from Taiwan's Food and Drug Administration, paving the way for its first shipment to the United States. Dr. Erick Co, President & CEO of Formosa Pharma, expressed enthusiasm regarding this milestone. He emphasized the significance of this initial shipment to Eyenovia, marking a high point in the development of APP13007. The company remains committed to delivering valuable therapies to ocular surgery patients globally.
Expanding Opportunities Beyond the U.S.
While the U.S. market holds immense potential, Formosa Pharma is also engaged in discussions with partners across various regions to prepare for future regulatory submissions for APP13007. The company's objective is to make this innovative drug accessible in diverse international markets, expanding its reach and impact.
About Formosa Pharmaceuticals, Inc.
Formosa Pharmaceuticals, Inc. is recognized as a clinical-stage biotechnology company focused primarily on ophthalmology and oncology. The company leverages its proprietary nanoparticle formulation technology, known as APNT®, to enhance the dissolution and bioavailability of active pharmaceutical ingredients (APIs) designated for topical, oral, and inhaler use. As a result, their formulations exhibit remarkable uniformity, purity, and stability, enabling the successful delivery of poorly soluble or extremely potent drug agents that traditionally face significant delivery challenges.
Frequently Asked Questions
What is APP13007?
APP13007 is Clobetasol Propionate Ophthalmic Suspension, 0.05%, developed by Formosa Pharmaceuticals for treating postoperative inflammation and pain in ophthalmic surgeries.
How does APP13007 differ from other treatments?
Unlike many treatments that require multiple daily doses, APP13007 only necessitates administration twice daily, providing a more convenient option for patients.
What milestone did Formosa Pharmaceuticals recently achieve?
The company successfully completed its first shipment of APP13007 to the U.S. market after obtaining a Drug Export License.
Who is the company's U.S. partner for APP13007?
Eyenovia, Inc. is Formosa Pharma's partner in the United States, and they have started pre-launch activities for the product.
What technology does Formosa Pharmaceuticals utilize?
Formosa Pharmaceuticals employs its proprietary APNT® nanotechnology platform to enhance drug formulation and delivery processes.
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