Formosa Pharmaceuticals, Inc. and AimMax Therapeutics, Inc. announced the joint submission of a new drug application (NDA) to the FDA for APP13007, intended for the treatment of pain and inflammation after ocular surgery.
Give me some background on these companies.
Based in Taipei City, Taiwan, Formosa Pharmaceuticals is a clinical stage biopharmaceutical company within the ophthalmology, oncology, and anti-infective space.
It has a proprietary nanoparticle formulation platform technology referred to as APNT, which is designed for topical, oral, and inhaler administration.
The Durham, North Carolina-based AimMax Therapeutics is focused on the research and development of biopharmaceuticals, such as anti-infectives against resistant bacteria, fungi, and other microorganisms along with anti-inflammatory products.
Now talk about APP13007.
APP13007 is a novel aqueous nanosuspension formulation containing corticosteroid clobetasol propionate (0.05%).
The compound contains a proprietary homogeneous nanosuspension and solution-like appearance, and is designed to provide eye comfort and enhanced drug penetration into ocular tissues.
What else?
Outside of the U.S., Formosa has already entered into a licensing agreement with China Grand Pharmaceutical for APP13007 to target marked delivery in China, Hong Kong, and Macau.
Tell me more about this proprietary technology.
Formosa’s APNT nanoparticle formulation platform targets reducing particle sizes in order to improve dissolution and bioavailability—all with a lower risk of contamination.
Now the clinical studies.
Two randomized, double-masked, pivotal phase 3 trials (NCT04810962) assessed APP13007 versus a placebo in 60+ sites across the United States.
Nearly 750 patients following cataract surgery were followed in one study; 151 patients were assessed in a corneal endothelial cell safety substudy (all patients were age 18+).
How were patients evaluated?
Patients were treated with one drop of APP13007, twice a day, for 14 days, according to the companies.
Primary outcomes included anterior chamber cell (ACC) count; ocular pain grade; adverse events (AEs); best-corrected visual acuity (BCVA); ocular anatomy safety; corneal endothelial cell measurements; and intraocular pressure (IOP).
And the findings?
APP13007 met its primary endpoints by providing a rapid and sustained clearance of ocular inflammation and pain, of which were statistically and clinically superior to the placebo (p< 0.001), according to the company.
Further, it exhibited a similar safety profile to the placebo and was well tolerated.
What’s next?
The FDA has 60 days to determine whether to accept Formosa and AimMax’s NDA. If accepted, it will take 6 to 10 months to review APP13007 and set a potential Prescription Drug User Fee Act (PDUFA) date.