latanoprost, a glaucoma drug. The Eyenovia formulation would be used to treat patients with chronic acute-angle closure glaucoma (CACG), a form of the disease in which the intraocular pressure builds up gradually. The company says there are no FDA-approved treatments for this form of glaucoma, which accounts for 10 percent of the glaucoma diagnoses in the U.S. and 50 percent of the diagnoses in China. Eyenovia projects the market for this application of the technology to top $700 million in the U.S.
The company’s other treatment, Microstat, is a formulation of phenylephrine and tropicamide, drugs that are used to dilate the pupils for eye exams. Eyenovia says that many ophthalmologists and optometrists use the same drug bottles on multiple patients, which increases the risk of contamination and spreading infection. Because Eyenovia’s device does not touch the eye, the company says it can reduce infection risks. Eyenovia estimates the U.S. market for eye dilation exceeds $150 million.
Phase 3 testing for the glaucoma and eye dilation applications of the Eyenovia technology is expected to start in the second half of the year. Eyenovia is also developing MicroTears, an over-the-counter use of the technology as a treatment for dry eye. A fourth product, MicroPine for myopia, is expected to start Phase 3 studies in 2019.
The Eyenovia technology was initially developed by Raleigh, NC, startup Corinthian Ophthalmic. According to the IPO filing, Eyenovia acquired Corinthian’s assets in 2014 in exchange for an equity stake in the New York company. That deal is now the subject of a lawsuit by a Corinthian shareholder who claims the transfer was fraudulent, according to the IPO filing. Eyenovia says its insurance protects the company for up to $10 million but adds that the unpredictability of the lawsuit may affect the company. The litigation is ongoing.
Eyenovia has been led from its start by CEO and chief medical officer Tsontcho Ianchulev. Before joining Eyenovia, Ianchulev was chief medical officer and head of technology and business development for Transcend Medical, which was acquired by Alcon, the eye care division of Novartis (NYSE: [[ticker:NVS]]). Ianchulev’s experience also includes five years at Genentech, where he headed the company’s ophthalmology research group and worked on the wet age-related macular degeneration drug ranizumab (Lucentis), which the FDA approved in 2006.
As of Sept. 30, 2017, Eyenovia had $7.4 million in cash. The company says it will use $12 million of the IPO proceeds to complete the Phase 3 study in glaucoma, and $2 million to complete the eye dilation study. An estimated $6.5 million would be earmarked for engineering and in-house manufacturing of products for clinical trials, as well as related regulatory work. Eyenovia expects the IPO proceeds will last two years.
Photo by the National Eye Institute.
