Eyenovia Stock Shoots Higher on Positive MicroLine Data in Late-Stage Presbyopia Study

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  • Eyenovia Inc EYEN has announced topline data from its VISION-1 Phase 3 study evaluating MicroLine, for the temporary improvement of near vision in adults with presbyopia.
  • The results will be presented at a future ophthalmic-focused medical meeting.
  • The study met its primary endpoint with a statistically significant proportion of subjects treated with MicroLine showing a three-line or more improvement in distance corrected near visual acuity versus placebo in low light conditions at two hours post-treatment.
  • MicroLine was well-tolerated. All adverse events were mild, and there were no serious adverse events.
  • Presbyopia is the age-related, progressive hardening of the eye's lens.
  • "Along with plans for VISION-2 in the coming months, we continue to prepare for the potential FDA approval of MydCombi for mydriasis in the fourth quarter and full enrollment of the CHAPERONE study for pediatric myopia shortly thereafter," said Dr. Sean Ianchulev, CEO & Chief Medical Officer.
  • MicroLine is a proprietary micro-dosed formulation of pilocarpine that is delivered via the Company's Optejet dispenser.
  • MydCombi is a first-in-class fixed-combination micro-formulation product (tropicamide 1% - phenylephrine 2.5%) candidate for pharmacologic mydriasis (eye dilation).
  • Price Action: EYEN shares are up 9.85% at $5.13 during the market session on the last check Tuesday.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsPhase 3 Trialpresbyopia
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