Formosa Pharmaceuticals News

Formosa Pharmaceuticals Announce FDA Acceptance of NDA Filing for APP13007 for the Treatment of Post-Operative Inflammation and Pain following Ocular Surgery

July 5th, 2023

TAIPEI, Taiwan – Formosa Pharmaceuticals, Inc. (6838.TWO) announce the United States Food & Drug Administration (US FDA) acceptance of its New Drug Application for APP13007, a novel aqueous nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%), for the treatment of inflammation and pain following ocular surgery.  The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 4, 2024.

The NDA submission followed the successful evaluation of APP13007 in two pivotal Phase 3 trials conducted across the United States.  Both trials compared APP13007 to its matching placebo in nearly 750 subjects following cataract surgery, including 151 subjects in a substudy to assess corneal endothelial cell safety.  Treatment with one drop twice daily for 14 days met the primary endpoints of rapid and sustained clearance of ocular inflammation and relief of ocular pain which were statistically superior to placebo (p<0.001).  APP13007 was well-tolerated with a safety profile similar to that of placebo.

“With the acceptance of our NDA submission by the FDA for formal review, Formosa Pharma marches forward in anticipation of approval in the first quarter of 2024, and attaining our goal of providing a new option for ophthalmologists and patients undergoing ocular surgery.  We look forward to supporting the regulatory review with the continued strong alliance with AimMax Therapeutics”, said Erick Co, Ph.D., Formosa Pharmaceuticals’ President and Chief Executive Officer.


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. 


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