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August 16, 2018

Eyenovia announces positive results of EYN PG21 clinical trial

Eyenovia, a company developing a pipeline of ophthalmology products using its patented piezo-print technology, has announced positive results of its EYN PG21 clinical trial of microdose latanoprost for reducing intraocular pressure (IOP) and patient usability.

Eyenovia, a company developing a pipeline of ophthalmology products using its patented piezo-print technology, has announced positive results of its EYN PG21 clinical trial of microdose latanoprost for reducing intraocular pressure (IOP) and patient usability.

The EYN PG21 clinical trial probed the medication administration effectiveness and IOP lowering effect of microdose latanoprost 0.005% in 60 eyes of 30 healthy participants..

The volunteers received once-daily microdose treatment over two consecutive days and then underwent diurnal IOP assessments four times per day.

According to the firm, the primary outcome had seen successful microdose delivery, with additional outcomes evaluating diurnal IOP change every day.

During the trial, after a brief medication administration training session, investigators administered high-precision piezo-print latanoprost with a single spray 95% of the time.

Another analysis of patient self-administration showed an 88% success rate following limited training.

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This improvement from the 39%-47% success rate was reported using a traditional eyedropper.

“We believe these compelling results further validate Eyenovia’s high-precision microdosing smart technology and build on the positive results from our Phase II mydriasis study.”

Furthermore, every single medication administration was within 1µL of the prescribed dose and the tear capacity of the eye.

This differs from the conventional eyedropper administration, which may provide as much as 300% more drug than the eye can hold with high variability in dosing.

The trial results also indicated lowering drug administration volume by 75% by delivering the microdose precisely and directly on the corneal surface. Piezo-print micro-formulated latanoprost achieved a reduction in diurnal IOP of up to 29% from baseline unmedicated IOP.

This is in line with the reported reduction of up to 26% achieved with the same focus of standard latanoprost eye drops.

Eyenovia chief executive officer and chief medical officer Dr. Sean Ianchulev said: “We believe these compelling results further validate Eyenovia’s high-precision microdosing smart technology and build on the positive results from our Phase II mydriasis study.

“These data are very informative for all of our upcoming Phase III programmes in prevention of myopia progression, chronic angle closure glaucoma and mydriasis by demonstrating that medications applied with our piezo-print technology are both effective and easy for patients to use.”

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