NEW YORK—Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, has announced the U.S. 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. “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,” stated Michael Rowe, chief executive officer of Eyenovia.

“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,” Rowe said.

Dr. Erick Co, president and CEO of Formosa Pharma, said, “This commercial U.S. 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.”

Eyenovia also announced the results of its recently commissioned market research indicating a strong level of interest in Clobetasol from ophthalmic surgeons based upon their review of its prescribing information. Key highlights from the survey include:

  • Of the 100 ophthalmic surgeons surveyed, respondents ranked efficacy as the most important characteristic of a postoperative steroid. In clinical studies of Clobetasol, approximately 80 percent of patients had complete relief from pain as soon as four days post-surgery (versus approximately 50 percent for patients who had vehicle).

  • The safety information specific to clobetasol was also of importance with clinical study results, which showed no single adverse event affected more than 2 percent of patients.

  • Managed care hurdles were cited by 53 percent 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.

  • Based solely on a review of the approved label and the way it will be distributed, the majority of respondents indicated a high level of interest in prescribing Clobetasol.