United States: Eyenovia announced it will discontinue its late-stage trial testing a drug-device combination aimed at treating myopia in children, after it showed no significant difference in slowing disease progression compared to a placebo. The company was investigating a low-dose atropine solution delivered via Optejet, its investigational drug delivery system, targeting children aged 3 to 12 years with progressive myopia, as reported by Reuters.
Study Results Show No Difference
The trial, which involved 252 participants, had to be stopped early after an independent safety and efficacy committee determined that myopia progression in treated eyes wasn’t different from that of the control group receiving placebo. Despite the fact that the adverse effects were mild and rare, insufficient therapeutic effect meant the continuation of the trial was not possible.
Optejet Delivery System Shows Safety
The Optejet system, designed to administer the drug in micro quantities, was noted for reducing the risk of overdose compared to traditional eyedrop dispensers. However, the results of the trial have raised questions about the future of the treatment in addressing progressive myopia.
Company Plans to Reassess Strategy and Explore Options
In light of the disappointing results, Eyenovia stated it would analyze the data further and evaluate potential next steps, including business combinations, reverse mergers, or asset sales. Despite the setback, the company continues to market its FDA-approved eye drops for managing pain and inflammation in post-eye surgery patients, as well as its pupil-dilating spray, Mydcombi, used with Optejet during eye tests, as reported by Reuters.