Biotech Values

[apljack]

EYEN-"Eyenovia Announces FDA Acceptance of IND Application for MicroPine to Reduce the Progression of Myopia"

NEW YORK, Feb. 06, 2019 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose therapeutics utilizing its patented piezo-print delivery technology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application to initiate the CHAPERONE study - the Company's Phase III registration trial of MicroPine to reduce the progression of myopia in children.

Currently, there are no FDA-approved therapies to slow the progression of myopia, a condition that, if uncontrolled, can in some cases be associated with major pathologic changes such as retinal atrophy, macular staphylomas, retinal detachment and visual impairment. It is estimated that approximately 9% of children in the United States have myopia resulting in a potential U.S. market for MicroPine of approximately $5 billion. Outside of the United States, we estimate the market potential for MicroPine is even larger – with up to approximately 80% of children starting out myopic in Asian markets. There is a growing body of evidence that supports the therapeutic effect of low dose atropine, potentially slowing myopia progression by 60-70%2-3.

(You can read more from this PR at: https://finance.yahoo.com/news/eyenovia-announces-fda-acceptance-ind-133000662.html

I posted on this little company about a month ago, with my heads up about their new microstat technology for eye drop delivery, their phase 3 trials for resolution of mydriasis and a general discussion of their potential pipeline. The company has since posted positive phase 3 results for use of their technology for inducing mydriasis in the clinic, and I expect that they will report on the resolution of clinic mydriasis in the next quarter. The above PR is icing as far as I'm concerned.

The basic investment premise, for me at least, is that their technology looks good, the applications for inducement and resolution of mydriasis in the clinic have a wide appeal, and there has been no development of similar technology or product in this space for some time. I have always been keen on the ophthalmology market (I have 3 contact lens patents) and know the space for having some of the highest margin products in healthcare. That said, this is a tiny "story" stock so far, with a very small float, no reported infrastructure for commercialization at this point, and will likely have to use a recently reported shelf registration to acquire the money to move towards commercialization. I'm in, take a closer look if you'll are interested in a ride.