NEW YORK--(BUSINESS WIRE)--Eyenovia Inc., a clinical-stage ophthalmic pharmaceutical company focused on the discovery, development, and commercialization of first-in-class microtherapeutics for the eye, announces positive results of its Phase II study of the safety and efficacy of its topical piezo-print microtherapeutic approach. The study validates the results of an earlier Phase II trial published in the October issue of the journal Therapeutic Delivery on the pharmacodynamic effect of topical microdosing for ophthalmic mydriasis. The study also provides additional understanding on the topical safety and systemic plasma levels and exposure of microtherapeutics compared to conventional topical dropper therapy.
- Eyenovia’s EYE 102 Phase II study demonstrates that Eyenovia’s proprietary microtherapeutic approach can reduce ocular side effects with an eight percent rate of ocular adverse events versus 66 percent for conventional topical treatment.
- High-precision piezo-formulated microdosing demonstrates superior pharmacologic effect and bioavailability over dose-equivalent dropper therapy.
“It is encouraging to see compelling data from this study of Eyenovia’s microtherapeutic approach which may provide a path to improve the therapeutic index of many eyedrops. This could have considerable impact as we grow the clinical application into chronic eye diseases such as glaucoma, dry eye and allergic eye disease, where the treatment paradigm has been hampered by overdose-related safety problems such as eye irritation, redness and even systemic cardiovascular and respiratory side effects,” said Robert N. Weinreb, MD, chairman and distinguished professor of ophthalmology at the University of California, San Diego, and director of the Shiley Eye Institute and the Hamilton Glaucoma Center.
“Microtherapeutics may be a viable solution to the topical preservative-related toxicity we see with many eye therapies. It could have categorical improvement of many classes of drugs such as prostaglandin analogues for glaucoma, where side effects like PGA-related periorbitopathy are dose related,” said Louis R. Pasquale, MD, professor of ophthalmology at Massachusetts Eye and Ear and Harvard Medical School.
About Eyenovia, Inc.
Eyenovia is a specialty biopharmaceutical company building a portfolio of next-generation topical eye treatments based on its proprietary delivery and formulation platform for microtherapeutics. Eyenovia’s pipeline is currently focused on the late-stage development of microtherapeutics for glaucoma and other eye diseases. For more information, visit www.eyenoviabio.com.