Eyenovia announces commercial availability of clobetasol propionate ophthalmic suspension 0.05% in US

(Image Credit: AdobeStock/Drazen)

Eyenovia has launched clobetasol propionate ophthalmic suspension 0.05% (Clobetasol) for the treatment of post-operative inflammation and pain following ocular surgery in the United States.

Clobetasol was approved by the US Food and Drug Administration (FDA) in March of 2024. Prior to the FDA approval, Eyenovia had acquired the commercial rights to Clobetasol from Formosa in August 2023. Formosa will be eligible for payments related to Eyenovia's attainment of sales milestones.

Michael Rowe, CEO of Eyenovia, commented on the commercial launch in a press release from the company stating,¹ “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. 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.”

Clobetasol is a potent steroid derived from Formosa Pharma's proprietary Active Pharmaceutical Nanoparticle Technology (APNT) formulation platform. Its twice-daily dosing regimen is a step away from most other post-surgical eye drops.

Eyenovia also conducted a survey in 100 ophthalmic surgeons to view their opinions on Clobetasol. According to the company,¹ results showed that efficacy was the most important characteristic of a post-operative steroid, and based solely on a review of the approved label and the way it will be distributed, majority of respondents indicated a high level of interest in prescribing Clobetasol.

Those surveyed also noted that the safety information of Clobetasol as well as the “low fixed price” were positives of the drop and something that would help them to consider prescribing the drug to patients.

References:

1. Eyenovia Announces Launch and Commercial Availability of Clobetasol Propionate Ophthalmic Suspension 0.05% for Post-Operative Inflammation and Pain Following Ocular Surgery. Press Release; September 26, 2024. Accessed September 30, 2024. https://ir.eyenovia.com/news-releases/news-release-details/eyenovia-announces-launch-and-commercial-availability-clobetasol