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# Phase 3 Eye Study Terminated After Data Review
- URL: https://www.fdaweb.com/phase-3-eye-study-terminated-after-data-review/
- Published: 2024-11-15T12:00:00.000Z
- Updated: 2026-09-14T14:47:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158196

Eyenovia says it is terminating the Phase 3 CHAPERONE study evaluating its proprietary drug-device combination of low-dose atropine in the company’s Optejet dispensing platform as a potential treatment for pediatric progressive myopia. The action is based on an independent data review committee analysis that found the trial is not meeting its primary endpoint of a less than 0.5 diopter progression in visual acuity over three years, according to the company.

The committee reviewed the data from 252 evaluable patients and “found that the rate of myopia progression was not significantly different between the two active treatment arms (0.01% and 0.1% atropine ophthalmic metered spray) and placebo,” Eyenovia says. “In the safety analysis, all dosages and placebo appeared to be well-tolerated, with a mild and infrequent adverse event profile.”