Amsterdam, The Netherlands—Presbia has received medical device registration approval in Brazil and Israel for a 3-mm lens designed to be a reversible treatment for presbyopia (Flexivue Microlens). Brazil and Israel join a list of more than 40 countries across Europe, Latin America, and the Middle East where the implant is commercially available.
The company has signed an exclusive agreement with ophthalmology products maker and distributor Mediphacos to oversee distribution of the lens in Brazil and is working with medical device distributer Dagesh Eyes to promote the lens in Israel. Both companies will recruit and train ophthalmologists to implant the device in patients.
Surgeons use a proprietary tool to insert the lens into the corneal stroma of a patient’s non-dominant eye; the lens is placed in a pocket created in the cornea by a femtosecond laser. The implant, about 15 µm in edge thickness, may stay in place permanently, or it can be removed or replaced if a patient’s presbyopia advances and a stronger prescription is required. The procedure takes less than 10 minutes and requires no general anesthesia, according to the company, and visual recovery takes a couple of days.
More than 500 patients have received the device and have reported a satisfaction rate of more than 90%, on average, according to Presbia. In the company’s latest post-market surveillance results, released in September, 78% of patients surveyed had near visual acuity between 20/16 and 20/25 9 months after receiving the implanted lens, with little to no change in their distance vision, according to the company.
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