Eyenovia Announces Presentation of Successful Phase 3 Studies at the ASCRS
Eyenovia announced the safety and efficacy results from the company’s two phase 3 trials, MIST-1 and MIST-2, for pharmacologic mydriasis (pupil dilation). The results were presented by David Wirta, MD, from the podium during the joint ASCRS-ASOA annual meeting, on May 5, 2019 in San Diego.
The MIST-1 study enrolled 64 subjects, in whom both eyes were treated on separate days with MicroStat, Eyenovia’s proprietary fixed combination, microdosed ophthalmic solution and with each component formulation (i.e. tropicamide and phenylephrine). The MIST-2 study enrolled 70 subjects, in whom both eyes were treated on separate days with MicroStat and a placebo solution. All treatments in the MIST-1 and MIST-2 trials were administered using Eyenovia’s Optejet dispenser that allows for dosing of approximately 8 microliters, which is less than 25% of the dose volume typically administered with eye dropper bottles.
In each trial, MicroStat was shown to be safe and effective for pharmacologic mydriasis achieving clinically and statistically superior mean pupil dilation. Collective results show approximately 94% of treated eyes achieved pupil dilation of at least 6mm at 35 minutes post-instillation. Dilation was rapid in most patients, with up to 64% of fixed-combination treated eyes achieving 6mm or greater dilation as early as 20 minutes post-installation. Adverse events were infrequent (~3% of subjects), transient, and generally mild in nature.
“We believe these outcomes further validate ocular microdosing and demonstrate that less can be more – less preservative and medication exposure still delivers a compelling ocular biologic effect while sparing the ocular surface from the toxicity associated with preservatives and some topical medications,” Dr. Wirta, principal investigator of the MIST-1 study, said in a company news release.
“The conclusion of our two phase 3 registration studies for MicroStat mark significant progress in Eyenovia’s pipeline,” Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer, said in the news release. “They validate the experience from our prior micro-dosing phase 2 studies and are informative and enabling for our forthcoming phase 3 trials in myopic progression and glaucoma. We believe the Optejet high-precision piezo-print delivery platform can improve the therapeutic index and tolerability of many ophthalmic therapies – unlocking the potential of ocular microdosing.”
Terry Kim, MD, member of Eyenovia’s Scientific Advisory Board and ASCRS Treasurer, said “In addition to quick and reliable efficacy and an excellent safety profile, MicroStat may offer additional benefits, including the potential to minimize cross-contamination seen with dropper bottles because its unique dispenser has a non-protruding nozzle for no-touch spray application. I am excited for the potential of this innovative product to enhance my clinic’s efficiency and improve my patients’ experience.”