In the latest update for strategic partners Eyenovia, Inc. and Formosa Pharmaceuticals, Inc., the companies announced Formosa has received clearance to begin shipping clobetasol propionate ophthalmic solution 0.05% (APP13007; clobetasol propionate), a drug candidate intended to treat pain and inflammation following ocular surgery, to the United States for commercialization.
Give me a refresh on Formosa.
The Taiwan-based clinical-stage biopharmaceutical company specializes in the ophthalmology, oncology, and anti-infective spaces.
Key to its science: A proprietary nanoparticle formulation platform technology referred to as Active Pharmaceutical Nanoparticle Technology (APNT), designed for topical, oral, and intranasal administration.
- Specifically: The APNT nanoparticle formulation platform targets reducing particle sizes in order to potentially improve dissolution and bioavailability—all with a lower risk of contamination.
Alright, now let’s talk about this candidate.
Clobetasol propionate is a novel aqueous nanosuspension formulation of corticosteroid clobetasol propionate (0.05%).
Its intent: With a proprietary homogeneous nanosuspension and solution-like appearance, the formulation is designed to provide eye comfort and—potentially—enhance drug penetration into ocular tissues.
- Dosing regimen: Administered topically, twice daily (BID), for 14 days
- Note: Standard treatments typically require up to four doses per day, Eyenovia noted.
And what makes it unique for Formosa?
Most notably, this was the first product developed using the company’s APNT platform.
Wasn’t this FDA-approved?
Indeed it was … earlier this year (March 2024) for the treatment of postoperative inflammation and pain following ocular surgery.
- Check out its prescribing information.
Special note about that: The formulation was originally developed in partnership between Formosa and AimMax Therapeutix, Inc.
- However: Prior to this FDA approval, Eyenovia purchased its exclusive U.S. rights in a deal worth up to $86 million (pending certain criteria).
Hold up: Didn’t the companies also recently partner on another indication?
They did! Just last month, Eyenovia and Formosa agreed to co-develop clobetasol propionate for short-term dry eye disease (DED) relief.
See those details here.
Back to this indication; What’s the clinical data on it?
Two randomized, double-masked, pivotal phase 3 trials (NCT04810962) assessed clobetasol propionate versus a placebo in nearly 700 patients at 60+ sites across the United States.
- Those results: Not only did the study meet its primary endpoints, but the formulation also provided a rapid and sustained clearance of ocular inflammation and pain—statistically and clinically superior to the placebo—and was well-tolerated.
Give me some numbers.
By 2 weeks post-surgery, 9/10 patients were reported to be pain-free—and 99% of patients demonstrated no intraocular pressure (IOP) increase.
As for adverse events (AEs): 2% or fewer participants demonstrated the following within the 2 weeks post-surgery :
- Eye inflammation
- Corneal edema
- Anterior chamber inflammation
- Cystoid macular edema
- IOP elevation
- Photophobia
- Vitreous detachment
What’s significant about its efficacy?
Most notably, this is the first new ophthalmic steroid approved in the U.S. in 15+ years—with benefits to potentially make it a topic choice for postop care, according to Francis S. Mah, MD, a member of the Eyenovia Scientific Advisory Board.
Also critical is the clinical data reporting its ability to provide postop pain relief and inflammation—quickly.
“[Data has shown that] 80% of patients experienced rapid, complete relief from postsurgical pain within four days of the procedure, and 60% achieved total resolution of inflammation within 15 days after surgery,” stated Dr. Mah, director of the Cornea Service at Scripps Clinic in La Jolla, California.
Nice! Now to this upcoming launch.
Formosa was granted a Taiwan Export License that enables the company to ship clobetasol propionate to the United States as a commercial product.
The launch date: Commercialization is expected in late September.