Formosa Pharmaceuticals, Inc. announced that Eyenovia, Inc. has purchased the exclusive U.S rights to APP13007, a drug candidate intended to treat pain and inflammation following ocular surgery.
Refresh me on Formosa.
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 intranasal administration.
Tell me more about this proprietary technology.
Formosa’s APNT nanoparticle formulation platform targets reducing particle sizes in order to potentially improve dissolution and bioavailability—all with a lower risk of contamination.
Gotcha. Now 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 possibly enhance drug penetration into ocular tissues.
What’s the dosing schedule?
The formulation is intended to be dose twice daily for 14 days.
And the clinical data on it?
Two randomized, double-masked, pivotal phase 3 trials (NCT04810962) assessed APP13007 versus a placebo in nearly 700 patients at 60+ sites across the United States.
APP13007 met its primary endpoints by providing a rapid and sustained clearance of ocular inflammation and pain—statistically and clinically superior to the placebo—and was well-tolerated.
How far in the US development process is it?
In May 2023, a new drug application (NDA) for the candidate was jointly submitted by Formosa and Aimax Therapeutics, Inc. (a North Carolina-based biopharmaceutical company).
Read the rundown here.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) Date of March 4, 2024.
Gotcha. So about this deal…
The entire package could be worth up to $86 million, with Eyenovia to make single-digit payments to Formosa (in the form of cash and common stock shares) at the following points:
- Upon agreement signing
- After FDA approval of APP13007
- Following first commercial sale
Additionally, Formosa will be eligible for milestone payment sales.
So where else is APP13007 in development?
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.
Noted. Lastly … what else has Eyenovia been up to?
This acquisition follows the May 2023 FDA approval of the company’s Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1% / 2.5% for mydriasis.
Read here for more details.