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 Brazil for 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. This approval adds to the growing list of more than 40 countries across Europe, Latin America and the Middle East where the Flexivue is now commercially available.
In addition, Presbia announced that it has signed an exclusive distribution agreement with Mediphacos, a leading global ophthalmology products maker and distributor, to oversee the distribution of the Flexivue in Brazil. As part of the agreement, Mediphacos will recruit and train top ophthalmologists from across Brazil to implant the Flexivue Microlens® in patients affected by the common age-related loss of the ability to focus on near objects through its extensive network of laser surgery centers.
“We have been dedicated to researching, developing and promoting products that improve eyesight for patients in Brazil and around the world for more than 30 years, and the Flexivue is a welcomed addition to our line of products as it is a proven alternative to reading glasses as a treatment for presbyopia,” said Marcelo Soares, President of Mediphacos.
“By adding Brazil to our list of approved registrations and partnering with Mediphacos, the benefits of the Flexivue Microlens is now available to even more patients who are looking for a better option to treat their near vision problems,” said Zohar Loshitzer, CEO of Presbia. “Mediphacos has a long history of delivering innovative and quality vision solutions to patients around the world, and we are excited to have forged this partnership to offer our superior presbyopia solution across Brazil.”
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.
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.