Formosa Pharmaceuticals and AimMax Therapeutics announce submission of NDA to FDA for APP13007

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Formosa Pharmaceuticals and AimMax Therapeutics have announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for APP13007.

According to a news release from Formosa Pharmaceuticals, APP13007 is 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 and enhanced drug penetration into ocular tissues.

APP13007 was previously evaluated in 2 pivotal Phase 3 trials in more than 60 sites across the United States. According to the release, 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.

Furthermore, treatment was conducted with one drop, twice daily for 14 days and 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.

Erick Co, PhD, Formosa Pharmaceuticals' President and Chief Executive Officer and AimMax Therapeutics' Founder and Chief Executive Officer, Laurene Wang, PhD, talked about the success of APP13007 and the trials in the release.

"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 Co.

"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 Wang.