Presbia Receives Registration Approval for Flexivue Microlens® in Israel
Treatment for Near Vision Loss Now Commercially Available in More Than 40 Countries Worldwide
AMSTERDAM--(BUSINESS WIRE)--Presbia, a medical device company and leader in near vision restoration, announced today that it has received medical device registration approval in Israel for its solution for near vision loss. With this approval, the Flexivue Microlens®, 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.
“Israel is a nation known for its technological advancement, and we believe the science of the Flexivue Microlens® will appeal to the growing adult population in Israel who want a solution that has delivered significant improvements in near vision for presbyopic patients.”
Presbia will be working with Dagesh Eyes, its medical device distributor in Israel, to promote the Flexivue Microlens®, a 3mm in diameter implantable lens, to leading ophthalmologists across the country.
“We are currently recruiting and training top ophthalmologists across Israel so that they can offer the Flexivue Microlens® solution to their patients that are seeking a better alternative to reading glasses to treat the common, age-related deterioration of their near vision,” said Sharon Guzman, Chief Executive Officer of Dagesh Eyes.
More than 500 patients have received the Flexivue Microlens® and have reported a satisfaction rate of more than 90 percent, on average. Presbia’s latest post-market surveillance results released last month showed that 78 percent 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.
“We are excited that our proven solution is now available in another country, as we continue to seek additional approvals across the globe,” said Zohar Loshitzer, Chief Executive Officer of Presbia. “Israel is a nation known for its technological advancement, and we believe the science of the Flexivue Microlens® will appeal to
the growing adult population in Israel who want a solution that has delivered significant improvements in near vision for presbyopic patients.”
About Presbia’s Flexivue Microlens®
Presbia’s Flexivue Microlens® 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® solution utilizes standard equipment and requires minimal additional training, the procedure requires no significant capital investment by the surgeon’s practice.
An animated video of the procedure is available at www.presbia.com.
“Israel is a nation known for its technological advancement, and we believe the science of the Flexivue Microlens® will appeal to the growing adult population in Israel who want a solution that has delivered significant improvements in near vision for presbyopic patients.”
ABOUT PRESBIA
Presbia is a leading ophthalmic-device company focused on the development of solutions for presbyopia, the age-related loss of the ability to read or focus on near objects. Chief among these approaches is the Presbia Flexivue Microlens®, a 3mm-diameter lens implanted using femtosecond laser technology. Further information is available at www.presbia.com.
Note: The Presbia Flexivue Microlens® and related medical procedures are not available in the United States and have not been evaluated or approved by the U.S. Food and Drug Administration.
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