Formosa Pharmaceuticals, Inc. and AimMax Therapeutix, Inc. have received FDA approval for clobetasol propionate ophthalmic suspension 0.05% (APP13007) to treat postoperative inflammation and pain following ocular surgery.
Updated March 22, 2024: Glance President Jaclyn Garlich, OD, FAAO, spoke with Eyenovia's Norbert Lowe, vice president of Commercial Operations, on what makes this solution unique.
First, a quick refresh on these companies.
The Taipei City, Taiwan-based Formosa Pharmaceuticals is a clinical stage biopharmaceutical company within the ophthalmology, oncology, and anti-infective space.
Its proprietary nanoparticle formulation platform technology (APNT) is designed for topical, oral, and inhaler administration (See below for more info on this platform).
AimMax Therapeutics, operating out of Durham, North Carolina, is focused on researching and developing biopharmaceuticals such as anti-infectives against resistant bacteria, fungi, and other microorganisms, along with anti-inflammatory products.
Now give me more on Formosa’s 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.
Click here to watch a video on this.
Gotcha. Now tell me about this suspension.
APP13007 is a novel aqueous nanosuspension formulation containing corticosteroid clobetasol propionate (0.05%).
Per Formosa, the compound was:
- Developed using its APNT platform
- Formulated with a proprietary homogeneous nanosuspension and solution-like appearance
- Designed to provide eye comfort and possibly enhance drug penetration into ocular tissues
Dosing schedule: the formulation is intended to be dosed twice daily (BID) for 14 days.
Its purpose: to resolve inflammation and pain following ocular surgery in a rapid and sustained manner, complete with a safety profile comparable to placebo and other marketed corticosteroids for similar indications.
What’s the clinical data on it?
The approval is based on two randomized, double-masked, pivotal phase 3 trials that examined APP12007 vs placebo in over 60 clinical sites across the U.S.
- CPN-301 (NCT04739709)
- CPN-302 (NCT04810962)
- Included a corneal endothelial cell sub-study
Per Formosa, the studies included a total of nearly 750 study participants (aged 18+) who underwent cataract surgery; 151 of these patients were assessed in a corneal endothelial cell safety substudy.
And those findings?
APP13007 met its primary endpoints by providing a rapid and sustained clearance of ocular inflammation and pain, of which both were statistically and clinically superior to the placebo (p< 0.001), according to the company.
Further, it also exhibited a similar safety profile to the placebo and was well tolerated.
Nice! What else should I know about this eye drop?
Who owns its U.S. rights. Or, more specifically, who doesn’t (the answer: Formosa).
Explain, please.
In August 2023, Eyenovia, Inc. purchased the exclusive U.S. rights to APP13007. (Read our coverage here.)
The deal (worth up to a potential $86 million) included Eyenovia making payments* to Formosa at the following time points:
- Upon agreement signing
- Following FDA approval of APP1300
- After first commercial sale
*In the form of cash and common stock shares
Note: Formosa is also eligible for milestone payment sales.
So what are Eyenovia’s immediate plans?
Per CEO Michael Rowe, the company is already working toward a mid-2024 launch.
“We believe that, given its more favorable [dosing schedule] and profile compared to other post-surgical steroid options, “ he stated, “it has the potential to capture a significant share of an estimated $1.3 billion annual market opportunity.”
And the overall significance?
The approval marks Formosa’s entry into the global marketplace, according to Formosa President and CEO Erick Co.
Lastly, the company noted that this formulation marks the first FDA-approved ophthalmic clobetasol propionate product as well as the first new steroid in 15+ years on the ophthalmic market.