Eyenovia, Inc. announced the U.S. commercial launch of clobetasol propionate ophthalmic suspension 0.05% (clobetasol propionate), FDA-approved and indicated to treat pain and inflammation following ocular surgery.
This news follows just two weeks after Taiwan-based Formosa Pharmaceuticals, Inc., a biopharmaceutical company, received clearance to begin shipping the suspension to the country.
Let’s back up for a moment. Start with this product.
Originally dubbed APP13007, the novel aqueous nanosuspension formulation contains corticosteroid clobetasol propionate (0.05%).
What it is: The compound is a proprietary homogeneous nanosuspension with a solution-like appearance and is designed to provide eye comfort and—potentially—enhance drug penetration into ocular tissues.
- The dosing schedule: twice daily (BID) for 14 days
And how does Formosa come into play with it?
In August 2023, Eyenovia purchased the U.S. exclusive rights from Formosa (which originally developed the suspension in partnership with AimMax Therapeutix, Inc.).
To note: Formosa’s proprietary active pharmaceutical nanoparticle technology (APNT) platform targets reducing particle sizes in order to potentially improve dissolution and bioavailability—all with a lower risk of contamination.
- Why this is important: It’s the basis for which clobetasol propionate was developed.
So when was the suspension FDA approved?
March 2024, in a deal potentially worth up to $86 million.
- See our coverage, including input from Eyenovia’s Norbert Lowe, vice president of Commercial Operation, on what makes the product unique.
- And check out its prescribing information.
And the clinical data on it?
To support its FDA approval, two randomized, double-masked, pivotal phase 3 trials (NCT04810962) assessed the suspension versus a placebo in nearly 700 patients at 60+ sites across the United States.
Those findings: Clobetasol propionate 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.
- The numbers: An estimated 80% of patients experienced complete pain relief four days after surgery (compared to 50% of patients after receiving other treatment forms, according to Eyenovia).
Any associated warnings and precautions?
A few … including:
- Intraocular pressure (IOP) increase
- IOP should be monitored if used for 10+ days
- Cataracts
- Delayed healing
- Corneal and scleral melting
- Bacterial infections
- Viral infections
- Fungal infections
And potential adverse reactions?
The product page noted that ocular adverse reactions occurred in ≥ 1% of clinical study participants. Such reactions included:
- Eye inflammation
- Corneal edema
- Anterior chamber inflammation
- Cystoid macular edema
- IOP elevation
- Photophobia
- Vitreous detachments
Keep in mind: Many of these reactions were noted as a direct result of the surgical procedure.
Any more recent data?
Sort of … along with its commercial launch announcement, Eyenovia also reported data from new market research that indicated a “strong level of interest from ophthalmic surgeons in clobetasol based upon their review of its prescribing information.”
- Research details: 100 ophthalmic surgeons surveyed across the United States
- The findings:
- Efficacy was ranked as the most important characteristic of a postop steroid
- Availability of clobetasol at a low fixed price (regardless of insurance status) was viewed as a positive way to eliminate insurance complications burning office staff
- Based only on a review of the solution’s approved label, a majority of surgeons demonstrated a high level of interest in prescribing it to their patients
- The findings:
And where can I order it?
According to the clobetasol propionate product site, physicians have two options:
- Purchasing via EyenoviaRx, a physician-direct ordering website
- Purchasing via Medvantx, a home delivery pharmacy partner
Good to know … now, isn’t the formulation in development for another indication?
Indeed it is—in yet another deal between Formosa and Eyenovia.
In August 2024, the companies announced they would co-develop clobetasol propionate for a new indication: dry eye disease (DED).
Key to this partnership: The use of Eyenovia’s Optejet delivery system (read about that here).