Presbia Coöperatief U.A. announced that it has received medical device registration approval in Israel for its solution for near vision loss. With this approval, the Flexivue Microlens(R), a safe, effective, reliable, and reversible treatment for presbyopia that eliminates dependence on reading glasses or contact lenses for seeing near objects, is now commercially available in more than 40 countries across Europe, Latin America and the Middle East. Presbia will be working with Dagesh Eyes, its medical device distributor in Israel, to promote the Flexivue Microlens(R), a 3mm in diameter implantable lens, to leading ophthalmologists across the country. More than 500 patients have received the Flexivue Microlens(R) and have reported a satisfaction rate of more than 90%, on average. Presbia's latest post-market surveillance results released last month showed that 78% of patients surveyed had near visual acuity between 20/16 to 20/25 nine months after receiving the implanted lens, with little to no change in their distance vision. Presbia's Flexivue Microlens(R) solution involves implanting a 3mm lens, approximately 15 microns in edge thickness, in the corneal stroma of the patient's non-dominant eye. Using Presbia's proprietary insertion tool, the lens is placed in a pocket created in the cornea by a femtosecond laser. The lens may stay in place permanently, or can be easily removed and/or replaced if the patient's presbyopia advances and a stronger prescription is required. The less than 10-minute procedure requires no general anesthesia and the patient's visual recovery takes only a couple of days. Since the Flexivue Microlens(R) solution utilizes standard equipment and requires minimal additional training; the procedure requires no significant capital investment by the surgeon's practice.
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