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Zorica Nastasic/E+ through Getty Photos
Eyenovia (NASDAQ:EYEN) stated its remedy MicroLine met the primary objective of a section 3 trial to deal with presbyopia (farsightedness).
The examine known as VISION-2 enrolled 140 individuals and evaluated Eyenovia’s 2% pilocarpine micro-array print (MAP) formulation, MicroLine, towards placebo, all administered through the corporate’s Optejet system.
Presbyopia is a gradual lack of the eyes’ means to deal with close by objects.
The evaluation of evaluable sufferers excluded a non-study associated adversarial occasion which impacted pupil dimension and reactivity (new onset anisocoria), the corporate stated in a press launch on Thursday.
Eyenovia famous that the trial met its fundamental objective with a statistically vital proportion of individuals handled with MicroLine exhibiting a 15-letter or extra enchancment in distance corrected close to visible acuity (DCNVA) with lower than a 5-letter loss in distance acuity, in comparison with placebo in low gentle circumstances at two hours post-treatment.
The examine additionally met all secondary objective at a statistically vital degree, the corporate added.
Eyenovia stated MicroLine (pilocarpine ophthalmic resolution) was nicely tolerated and adversarial occasions have been reported in fewer than 3% of sufferers, all have been gentle and/or transient.
“We stay up for assembly with the FDA inside our deliberate commercialization timeline in preparation for a possible new drug software (NDA) submission. MicroLine, if permitted, could be the one choice that’s designed to offer the ease-of-use, comfort, and diminished publicity to drug and preservatives that we imagine are vital advantages of the Optejet system,” stated Eyenovia CEO Michael Rowe.
EYEN +9.36% to $2.63 premarket Oct. 20
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