Eyenovia Launches Clobetasol for Postoperative Ocular Surgery Pain and Inflammation
Eyenovia announced the US launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%, which is designed to address postoperative inflammation and pain following ocular surgeries. The FDA approval and launch marks the first new ophthalmic steroid to be approved in over 15 years.
“The commercial launch of clobetasol represents a significant milestone for our company, and as the first new ophthalmic steroid to be approved in more than 15 years, a meaningful advancement in the field of ocular surgery," Michael Rowe, Chief Executive Officer of Eyenovia, said in a company news release. "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.”
The FDA approval of clobetasol is based on clinical trial results demonstrating its effectiveness in reducing inflammation and pain following surgery. Approximately 80% of patients experienced complete relief from pain as early as 4 days after surgery, significantly outperforming other treatments, where only 50% of patients saw similar results, according to Eyenovia.
Clobetasol’s distribution method bypasses the complications often associated with managed care and insurance, ensuring that patients can access the medication at a low fixed price, regardless of their insurance coverage, Eyenovia stated in a news release.
In collaboration with Eyenovia, Formosa Pharma has been instrumental in the development of clobetasol.
“This commercial US launch of clobetasol has been much anticipated and we are excited to provide this formidable therapy to ocular surgery patients in the U.S. with our partner, Eyenovia. We also look forward to further collaborating with Eyenovia to develop clobetasol as a treatment for dry eye utilizing its Optejet platform technology," said Dr. Erick Co, President and CEO of Formosa Pharma.