Eyenovia Launches Clobetasol Propionate Ophthalmic Suspension for Post-Op Inflammation and Pain

Eyenovia, Inc., a company specializing in ophthalmic technology, has announced the U.S. launch and commercial availability of Clobetasol Propionate Ophthalmic Suspension 0.05% ("Clobetasol"). Approved by the FDA, Clobetasol is intended for treating post-operative inflammation and pain after ocular surgery. This new steroid is the first ophthalmic steroid approved in the last 15 years, marking a significant advancement in the field.

Michael Rowe, CEO of Eyenovia, expressed pride in this milestone, emphasizing Clobetasol's efficacy, safety profile, and convenient twice-daily dosing. He believes these features will make it highly appealing to eye doctors. The streamlined distribution model of Clobetasol is designed to eliminate insurance complications, further increasing its attractiveness to healthcare providers.

Dr. Erick Co, President and CEO of Formosa Pharma, also shared his enthusiasm for the U.S. launch. He highlighted the anticipation surrounding this product and the collaboration with Eyenovia to bring effective therapy options to patients. Dr. Co also mentioned future plans to develop Clobetasol as a treatment for dry eye using Eyenovia's Optejet® platform technology.

Recent market research commissioned by Eyenovia reflects a strong interest among ophthalmic surgeons in Clobetasol. Key findings from the survey of 100 ophthalmic surgeons include:

1. **Efficacy**: Surgeons ranked efficacy as the most critical characteristic of a post-operative steroid. In clinical trials, about 80% of patients reported complete pain relief within four days post-surgery, compared to approximately 50% for those given a placebo.

2. **Safety**: The safety of Clobetasol was another vital factor, with clinical study results showing that no single adverse event affected more than 2% of patients.

3. **Managed Care Hurdles**: Over half of the respondents (53%) identified managed care obstacles as significant challenges in prescribing ophthalmic steroids. The fixed, low pricing of Clobetasol, irrespective of insurance status, was seen as a beneficial approach to overcoming these hurdles.

4. **Interest in Prescribing**: A majority of the surgeons showed a high level of interest in prescribing Clobetasol based on its approved label and distribution method.

Eyenovia, Inc. focuses on developing microdose array print therapeutics using its Optejet® platform technology. The company is currently commercializing MYDCOMBI® for mydriasis and Clobetasol for post-operative inflammation and pain. Additionally, Eyenovia is working on late-stage development of treatments for pediatric progressive myopia and exploring out-licensing opportunities for other indications.