Eyenovia announced positive results from the MicroStat Phase 3 MIST-1 study, which examined the safety and efficacy of the companyâ€™s first-in-class, MicroStat fixed-combination formulation for Mydriasis.
The study was a US-based, randomized, double-masked, superiority trial that enrolled 64 subjects, in whom both eyes were treated on separate days with Eyenovia’s proprietary MicroStat fixed combination formulation of phenylephrine 2.5% – tropicamide 1%. MicroStat was compared against each component formulation of tropicamide and phenylephrine, respectively. All treatments were administered using Eyenoviaâ€™s OpteJet technology.
For the primary efficacy outcome of mean pupil dilation at 35 minutes post-administration, the MicroStat group demonstrated a statistically and clinically superior mydriatic effect as compared to either component formulation. Additional outcomes demonstrated 94% of eyes achieved 6 mm or greater pupil dilation at 35 minutes post-administration.Â This compared with 78% and 1.6% for the tropicamide-only and phenylephrine-only groups, respectively. At 20 minutes, 57% of the MicroStat-treated eyes achieved 6 mm dilation or greater versus 38% of the tropicamide treated eyes and none in the phenylephrine treated eyes.
â€śWe are excited with the results of the phase 3 MIST-1 study. The MicroStat fixed-combination administered with the OpteJet delivered strong efficacy and was well tolerated by all subjects,” Sean Ianchulev, MD, MPH, Eyenoviaâ€™s Chief Executive Officer and Chief Medical Officer, said in a company news release. “We believe this is the first time in a phase 3 FDA registration program that drugs have been delivered to the ocular surface using a smart microdose eyedropper-free delivery systemâ€”a meaningful step forward as we try to modernize the legacy eyedropper paradigm. These data from a well-controlled FDA registration study further validate our microdose technology platform and support our extensive clinical development pipeline for other microdosed ophthalmic solutions. We look forward to announcing topline data from our MIST-2 study in short order.â€ť
â€śThere are an estimated 80 million in-office exams performed each year in the United States requiring mydriasis, an integral part of comprehensive eye exams. Eyenoviaâ€™s MIST-1 study results demonstrate that not only does MicroStat successfully induce significant pupil dilation, but it does so rapidly,” David Wirta, MD, principal investigator of the MIST-1 study, said in the news release. “We believe that having a fixed combination option to achieve mydriasis has the potential to streamline the in-office examination process, potentially increasing physician efficiency and patient through-put volume.â€ť
The company expects to present the detailed results from the MIST-1 trial in a forthcoming scientific forum.