September 27, 2024 — Eyenovia Inc. announced the US launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%, approved by the FDA for the treatment of postoperative inflammation and pain following ocular surgery.
According to Michael Rowe, CEO of Eyenovia, “It is the first new ophthalmic steroid to be approved in more than 15 years, a meaningful advancement in the field of ocular surgery. With its efficacy and safety profile, convenient twice-a-day dosing regimen, and streamlined distribution that is designed to eliminate complications from insurance, we believe Clobetasol will generate strong interest among eye doctors,” he stated in a company press release.
In addition, Eyenovia says the results of its recently commissioned market research indicate a strong level of interest from ophthalmic surgeons in Clobetasol based upon their review of its prescribing information. According to the survey, of the 100 ophthalmic surgeons who participated, respondents ranked efficacy as the most important characteristic of a postoperative steroid. In clinical studies of Clobetasol, approximately 80% of patients had complete relief from pain as soon as 4 days post-surgery (vs approximately 50% for patients who had vehicle).
The survey also highlighted that the safety information specific to clobetasol was also of importance with clinical study results showing no single adverse event affected more than 2% of patients. In addition, managed care hurdles were cited by 53% of respondents as the most significant issue with prescribing ophthalmic steroids. Knowing that Clobetasol will be made available to patients at a low fixed price regardless of their insurance status was seen by surgeons as a positive way to eliminate insurance complications that burden office staff.