Study of atropine-based myopia treatment fails to meet primary efficacy endpoint
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Eyenovia’s phase 3 CHAPERONE study evaluating low-dose atropine delivered via the company’s Optejet dispenser is not meeting its primary endpoint of a less than 0.50 D progression in visual acuity over 3 years, according to a press release.
“We are disappointed that the [Data Review Committee (DRC)] determined that the CHAPERONE study does not appear to be meeting its primary efficacy endpoint,” Michael Rowe, Eyenovia’s CEO, said in the release. “We plan to terminate the study, review the data more thoroughly and evaluate next steps.”
According to the release, the DRC reviewed data from 252 participants and found that the rate of myopia progression was not significantly different between groups treated with 0.01% and 0.1% atropine ophthalmic metered spray and placebo. However, all dosages and placebo were well-tolerated, with mild and infrequent adverse effects.
The company is now exploring options for the program, including a business combination, reverse merger or asset sales.
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