Eyenovia ( NASDAQ: EYEN ) said its treatment MicroLine met the main goal of a phase 3 trial to treat presbyopia (farsightedness).
The study called VISION-2 enrolled 140 people and evaluated Eyenovia's 2% pilocarpine micro-array print (MAP) formulation, MicroLine, against placebo, all administered via the company's Optejet device.
Presbyopia is a gradual loss of the eyes' ability to focus on nearby objects.
The analysis of evaluable patients excluded a non-study related adverse event which impacted pupil size and reactivity (new onset anisocoria), the company said in a press release on Thursday.
Eyenovia noted that the trial met its main goal with a statistically significant proportion of people treated with MicroLine showing a 15-letter or more improvement in distance corrected near visual acuity (DCNVA) with less than a 5-letter loss in distance acuity, compared to placebo in low light conditions at two hours post-treatment.
The study also met all secondary goal at a statistically significant level, the company added.
Eyenovia said MicroLine (pilocarpine ophthalmic solution) was well tolerated and adverse events were reported in fewer than 3% of patients, all were mild and/or transient.
"We look forward to meeting with the FDA within our planned commercialization timeline in preparation for a potential new drug application (NDA) submission. MicroLine, if approved, would be the only option that is designed to provide the ease-of-use, convenience, and reduced exposure to drug and preservatives that we believe are significant benefits of the Optejet device," said Eyenovia CEO Michael Rowe.
EYEN +9.36% to $2.63 premarket Oct. 20
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Eyenovia stock jumps as MicroLine helps improve vision in phase 3 trial