The US ophthalmic technology company’s stock dropped from $0.34 per share at market close on 14 November to a $0.10 at market close on 15 November. Credit: Shutterstock / Nicoleta Ionescu.

Eyenovia has seen its stock price plummet by more than two-thirds after a Phase III study of its drug-device combination for myopia failed to meet its primary endpoint.

The US ophthalmic technology company’s stock dropped from $0.34 per share at market close on 14 November to $0.10 at close on 15 November, following the announcement that the CHAPERONE study failed to meet its primary endpoint of a less than 0.5 dioptre progression in visual acuity over three years. The company will now terminate the study.

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The CHAPERONE trial (NCT03942419) examined the company’s combination of low-dose atropine using its Optejet dispensing platform as a potential treatment for paediatric progressive myopia. Efficacy data taken from 252 patients showed that the rate of myopia progression was not significantly different between the experimental and active comparator arms. All dosages and the placebo appeared to be well-tolerated, with the company claiming only mild and infrequent adverse events as part of the trial.

Eyenovia chief executive officer Michael Rowe said: “We are disappointed that the DRC determined that the CHAPERONE study does not appear to be meeting its primary efficacy endpoint. We plan to terminate the study, review the data more thoroughly, and evaluate the next steps.

“On behalf of the entire company, I would like to express my sincere appreciation to the children, parents, caregivers and healthcare professionals who participated in this trial, as well as all the Eyenovia team members for their exceptional work on this programme.”

The company has now confirmed that it has been forced to weigh up its strategic options, refusing to rule out a potential business combination, reverse merger, asset sales or a combination of those alternatives in hopes of preserving company value.

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The company’s Optejet medication dispensing platform is driven towards addressing front-of-the-eye diseases due to its ease of use for the treatment of conditions such as myopia, a condition that the US National Institutes of Health (NIH) estimates impacts around 41.6% of Americans.

Elsewhere in the field of myopia treatment, US competitor Vyluma has reported positive top-line data from the second stage of the Phase III Childhood Atropine for Myopia Progression (CHAMP) clinical study. Meanwhile, the US Food and Drug Administration (FDA) has approved Johnson & Johnson Vision’s ACUVUE Ability Overnight Therapeutic Lenses for managing myopia.