FDA accepts IND for Eyenovia’s microdosed presbyopia formulation
The FDA has accepted an investigational new drug application for Eyenovia’s MicroLine intended for symptomatic treatment of near vision due to presbyopia, according to a press release.
MicroLine is a proprietary pilocarpine formulation delivered via Eyenovia’s Optejet dispenser.
"Eyenovia delivers its proprietary microdose array print formulation in a way that is radically different from traditional eyedroppers, ensuring a more targeted and consistent dose," Sean Ianchulev, MD, MPH, CEO and chief medical officer of Eyenovia told Healio/OSN. "In our CHAPERONE study, which we are in the process of transferring over to Bausch Health as part of the recent licensing announcement, we know that the vast majority of children in that study, some as young as 6 years old, are self-instilling their medication using the Optajet dispenser. Throughout our phase 3 programs we have measured the ability to properly instill medication using the Optejet and it has been consistently easier and more reliable than what has been historically reported for eye drops."
The acceptance clears the way for Eyenovia to initiate the phase 3 VISION program, beginning with VISION-1, a double-masked, placebo-controlled, crossover, superiority trial, whose primary endpoint is binocular distance-corrected near visual acuity. Persons aged 40 to 60 years will be enrolled, the release said.
“We are on track to initiate the VISION-1 phase 3 trial by year end, subject to any impacts of COVID-19.” Ianchulev, said in the release. “We believe the VISION studies could confirm that our approach to presbyopia is a well-tolerated, effective, on-demand complement to reading glasses for those situations when wearing glasses is less than ideal.”
The VISION trials can be completed with fewer than 100 patients, Ianchulev said. Eyenovia anticipates having results in the first half of 2021.
Editor's note: On Dec. 4, 2020, this article was updated to include additional comments from Sean Ianchulev, MD, MPH.