Formosa and AimMax Submit NDA to the FDA for APP13007 for Postoperative Inflammation and Pain After Ocular Surgery

Formosa Pharmaceuticals and AimMax Therapeutics announced the submission of a new drug application to the FDA for APP13007, a novel aqueous nanosuspension formulation of the corticosteroid, clobetasol propionate (0.05%), for the treatment of inflammation and pain following ocular surgery. This proprietary homogeneous nanosuspension has a solution-like appearance designed to offer 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, PhD, Formosa Pharmaceuticals' President and Chief Executive Officer.

"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 Chief Executive Officer, Laurene Wang, PhD.