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EyeYon Medical announces receiving of a FDA 510 (K) clearance

01
Aug
2016

August 14, 2016

Israeli company EyeYon Medical, has received US marketing authorization for its medical contact lens for the treatment of corneal edema. The product is already approved for marketing in Europe, and has been sold there since early 2016.

About two million people develop the corneal edema chronic disease annually. The treatment for advanced corneal edema involves corneal transplant; however, such a transplant requires finding a donor, leading to a prolonged wait. Only 200,000 corneal transplants are carried out annually, while 13 million people are waiting for the transplant. Meanwhile, the patients use eye drop treatments, which are not sufficiently effective for most of them.

EyeYon’s lenses are constructed in such a manner that they create a space above the eye where medical drops can be stored. This enables them to have extended contact with the eye, making them more effective. The product is undergoing clinical trials in both the US and Europe, although it already received authorization. The trials involve 100 patients. So far, the product has been field-tested on more than 1,000 patients, who reported a significant reduction in pain and immediate improvement in vision.

The product is currently sold with a doctor’s prescription and is purchased by patients, who have to pay $50 (or €50) for lenses for about two weeks out of their own pockets. In the future, the company hopes to receive some kind of indemnification from insurance companies worldwide, but it believes that the product will sell well even if patients have to pay for it directly.

Edema-treatment drops are the first application of this technology, with the medical agent here being salt water. In the future, this same technology could be used for various other kinds of treatment. The stored medicine could be antibiotics, steroids, anti-inflammatory agents, dry eye medicine and more. The company is currently holding clinical trials in Holland for the treatment of dry eye syndrome using the lens.

The company has also been developing another product, a silicone film attached to the posterior corneal surface, preventing transfer of fluids into the cornea and thereby preventing the formation of edema in the first place.

EyeYon was founded in 2011 by two ophthalmologists from Clalit Health Services: Dr. Ofer Daphna and Dr. Arie Marcovich and was commercialized via Mor Research Applications Ltd., the Clalit Health Services technology commercialization company. It emerged from the Van Leer incubator (today, VLX) with the support of contact lens company Sagam Optical Products. EyeYon’s first significant fund raising round was from Pontifax and Triventures; so far, it has raised $5 million. In about six months, it is expected to start another fund raising round. The company is managed by CEO Nahum Ferera.

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