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EYN PG21 trial takes the pressure off
NEW YORK,—Today, Eyenovia, Inc. announced positive results of its EYN PG21 proof-of-concept study of microdose latanoprost for the lowering of intraocular pressure (IOP) and patient usability. Eyenovia is a specialty biopharmaceutical company developing a pipeline of ophthalmology products utilizing its patented piezo-print technology to deliver microdosed medications topically to the eye.
The EYN PG21 clinical study investigated the medication administration effectiveness and IOP lowering effect of microdose latanoprost 0.005% in 60 eyes of 30 healthy volunteers. Participants received once daily microdose treatment over 2 consecutive days and underwent diurnal IOP assessments. The primary outcome was success of microdose delivery, with additional outcomes evaluating diurnal IOP change each day.
The study results also demonstrated that, while reducing drug administration volume by 75% by delivering the microdose accurately and directly on the corneal surface, piezo-print micro-formulated latanoprost achieved a very robust reduction in diurnal IOP of up to 29% from baseline unmedicated IOP. This is consistent with the reported reduction of up to 26% achieved with the same concentration of standard latanoprost eye drops.
Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer commented, “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 programs 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.”
After a brief medication administration training session, investigators successfully administered high-precision piezo-print latanoprost with a single spray 95% of the time. A separate evaluation of patient self-administration showed an 88% success rate, following limited training. This is a substantive improvement from the 39%-47% success rate reported in the literature using a conventional eyedropper. In addition, each single medication administration was within 1 µL of the prescribed dose, and the tear capacity of the eye. This differs from traditional eyedropper administration, which may deliver as much as 300% more drug than the eye can hold, with high variability of dosing.
“Conventional eye drops may overdose the eye’s tear film capacity by as much as 300%, causing significant ocular and systemic side effects leading to hyperemia, sunken globe (peri-orbitopathy), pharmacologic dermatitis and bradycardia, and ultimately the poor compliance that plagues almost all front-of-the-eye treatments,” said Dr. Louis R. Pasquale, MD, FARVO, Professor of Ophthalmology at Harvard Medical School. “Microdosing has the potential to address all those problems by providing physiologic high-precision dosing to the eye that stays in the eye.”
“Following Eyenovia’s earlier studies, these data demonstrate that microdosing can open a new chapter in topical eye disease therapy with high-precision microdosing that dramatically improves the therapeutic index of many front-of-the-eye therapies. Eyenovia’s upcoming Phase III programs in myopia, glaucoma and mydriasis are first-in-class indications that have the potential to introduce a new wave of formulations with improved safety, tolerability and smart-compliance monitoring,” added Dr. Robert N. Weinreb, Chairman and Professor of Ophthalmology at the University of California, San Diego.