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.
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
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