Eyenovia, Inc. has announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% (Clobetasol) for the treatment of post-operative inflammation and pain following ocular surgery. The FDA approved Clobetasol in March 2024, and Eyenovia acquired the commercial rights from Formosa Pharmaceuticals in August 2023.
Clinical Efficacy and Safety
The approval and launch are supported by data from a Phase 3 study (CPN-302), which demonstrated significant and rapid relief from inflammation and pain compared to placebo. According to Eyenovia, the study results, presented at the American Academy of Ophthalmology (AAO) 2024 Expo, showed improvement in visual acuity and a favorable safety profile. In clinical studies of Clobetasol, approximately 80% of patients had complete relief from pain as soon as four days post-surgery, versus approximately 50% for patients who had vehicle.
Convenient Dosing and Distribution
Clobetasol features a twice-daily dosing regimen, a departure from many other post-surgical eye drops that require more frequent administration. Michael Rowe, CEO of Eyenovia, highlighted the convenience and streamlined distribution model, designed to minimize insurance complications, as key factors expected to drive strong interest among eye doctors.
Surgeon Perspectives
A survey of 100 ophthalmic surgeons indicated that efficacy is the most important characteristic of a post-operative steroid. The survey also revealed that the safety information of Clobetasol and its low fixed price, regardless of insurance status, were viewed positively, potentially increasing its adoption among surgeons.
Future Development
Eyenovia and Formosa Pharma are also exploring the development of Clobetasol as a treatment for dry eye, utilizing Eyenovia's Optejet platform technology.
