Formosa Pharmaceuticals, Inc. and AimMax Therapeutics, Inc. announced the submission of a new drug application (NDA) to the United States Food & Drug Administration (US FDA) 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.
This proprietary homogeneous nanosuspension has a solution-like appearance which offers great comfort to the eyes and enhanced drug penetration into ocular tissues.
APP13007 was evaluated in two pivotal phase 3 trials in more than 60 sites across the United States. Both trials were randomized, double-masked studies comparing APP13007 to its matching placebo in nearly 750 subjects following cataract surgery, and included 151 subjects in a corneal endothelial cell safety substudy.
Treatment with “one drop twice daily” for 14 days met the primary endpoints by producing rapid and sustained clearance of ocular inflammation and relief of ocular pain which were statistically and clinically superior to placebo (p<0.001). APP13007 was well-tolerated with a safety profile similar to that of placebo.
“Formosa Pharma is delighted to attain this significant milestone, while taking a step closer to providing a formidable option for ophthalmologists and patients undergoing ocular surgery. We credit the guidance and expertise of our co-development partners at AimMax Therapeutics in working together to realize this corporate achievement”, said Erick Co, Ph.D., Formosa Pharmaceuticals’ president and CEO.
“We are excited to see this novel formulation of Formosa Pharma approaching the healthcare community to offer greater convenience, potency and comfort, and importantly, improvement of patient’s quality of life via fast relief of pain and rapid regain of visual acuity post ocular surgery”, said AimMax Therapeutics’ founder and CEO, Laurene Wang, PhD.
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.
About AimMax Therapeutics, Inc.
AimMax Therapeutics, Inc., engages in the research and development of pharmaceuticals at various stages of development through its discovery or by co-development with strategic partners. The company’s R&D strengths derive from extensive and synergistic experience in basic and nonclinical research, translational medicine, clinical trial design, and regulatory and commercial strategy.