Formosa Pharmaceuticals News

Formosa Pharmaceuticals, completes successful pre-NDA Meeting with the US FDA and plans for NDA submission of APP13007

November 8th, 2022

Taipei, Taiwan – Formosa Pharmaceuticals, Inc. (TWO.6838) and development partner, AimMax Therapeutics, Inc. (US), announced the completion of a pre-NDA meeting with the US FDA for its lead program, APP13007, a 14-day, twice-daily eyedrop for the treatment of inflammation and pain after ocular surgery.  The favorable outcome of the meeting lays the path toward the company’s planned NDA submission in 2023.

APP13007 is a novel nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%).  Earlier this year, Formosa Pharmaceuticals announced their two pivotal Phase 3 clinical trials (CPN-301 and CPN-302) successfully achieved the endpoints of rapid and sustained clearance of ocular inflammation and cure of ocular pain with statistical significance (p<0.001) and superiority over placebo.  Both randomized, double-masked, placebo-controlled clinical trials involved a total of 748 subjects across more than 60 sites in the United States.

APP13007 is derived from Formosa Pharmaceuticals’ proprietary APNT Nanoparticle Formulation Technology, which reduces the particle size of clobetasol propionate under mild operating conditions using GRAS (Generally Recognized as Safe) excipients. The resulting low-dose formulation enhances distribution and delivery into relevant eye compartments, providing rapid relief of ocular inflammation and pain with a safety profile comparable to placebo.

Dr. Erick Co, Chief Executive Officer of Formosa Pharmaceuticals, said, “The current standards of care with regard to steroid-based eye drops face challenges in meeting the high expectations of efficacy, safety, treatment compliance, and comfort.  APP13007 is well positioned to address all of these aspects effectively, and is expected to offer an exciting new option to physicians and patients following ophthalmic surgery.  We express immense gratitude to our clinical colleagues at AimMax Therapeutics for their guidance and diligence throughout the development pathway.”

According to Market Scope, 7.5 million ocular surgeries were performed in the United States in 2021, of which more than half were cataract-related.  Conservative estimates forecast that annual ocular surgeries will grow to more than 9 million by 2029.

 

About Formosa Pharmaceuticals, Inc.:

Formosa Pharmaceuticals is a clinical phase biotech company focused primarily 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.

Formosa Pharmaceuticals’ advanced programs are:

  • APP13007:  Corticosteroid eye drop for the treatment of inflammation and pain after ocular surgery.  NDA submission is planned in 2023.
  • TSY-0110:  Biosimilar of ado-trastuzumab emtansine (Kadcyla®).  Phase 1 trials are expected to commence in 2023.

 

About AimMax Therapeutics, Inc.:

AimMax Therapeutics, Inc., located in Research Triangle Park, North Carolina, United States, engages in the research and development of biopharmaceuticals at various stages of development through its own research/discovery or by co-development with strategic partners, primarily in the anti-inflammatory and anti-infective therapeutic areas.  The company’s R&D strengths derive from extensive and synergistic experience in basic and nonclincal research, translational medicine, clinical trial design, and regulatory and commercial strategy.

For more information about AimMax Therapeutics, please visit www.aimmaxrx.com.

 

Contact person:
Formosa Pharmaceuticals, Inc.
Wayne Wei, Director of Business Development
waynewei@formosapharma.com
+886-2-2755-7659

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