Eyenovia Inc. has decided to halt its Phase III clinical trial evaluating a drug-device combination product for the treatment of pediatric myopia. The decision follows a recommendation from the trial's data monitoring committee, which concluded that the study was unlikely to meet its primary endpoint. This development has led Eyenovia to explore various strategic alternatives for the company.
The Phase III trial was designed to assess the efficacy and safety of a novel drug-device combination in slowing the progression of myopia in children. Myopia, or nearsightedness, is a growing global health concern, with increasing prevalence rates, particularly among children. The condition not only requires corrective lenses but can also increase the risk of serious eye conditions later in life. Current treatments include specialized contact lenses and atropine eye drops, but there remains a significant unmet need for more effective and convenient therapies.
Eyenovia's investigational product aimed to address this need by delivering a precise dose of medication via a proprietary device, potentially offering improved efficacy and compliance compared to existing treatments. However, the data monitoring committee's assessment indicated that the trial was not on track to demonstrate a statistically significant benefit.
"While we are disappointed with this outcome, we remain committed to advancing innovative solutions in ophthalmology," said a company spokesperson. "We are now evaluating all available strategic options to maximize value for our shareholders."
The company is now considering various paths forward, including potential partnerships, licensing agreements, or a shift in focus to other areas within ophthalmology. The termination of the Phase III trial represents a setback for Eyenovia's myopia program but also underscores the inherent risks and challenges in pharmaceutical research and development.
