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| Kamra Inlay with dimensions--Courtesy of AcuFocus |
The FDA just approved the first short-distance vision implant for patients who have not had cataract surgery via the stringent PMA pathway. AcuFocus' Kamra inlay is an opaque, ring-shaped device that improves vision in the eye in which it is implanted but does not affect the distance vision of both eyes working in combination, the FDA says.
Typically, patients with the age-related condition of presbyopia undergo cataract surgery to replace the faulty lens in the eye with an artificial one, such as an intraocular lens. The Kamra inlay is instead inserted with the assistance of a laser, which creates a pocket in the cornea where the device then implanted.
The approval came despite a close vote from the FDA's Ophthalmic Devices Advisory Panel in June. The group of experts voted that the device is not safe in the proposed indication, but ultimately said the benefits still outweigh the risks, in a 4-3 vote with one abstention.
Working the Kamra's favor was postmarket data from the 30+ countries outside the U.S. where it's already available, including European ones, where the inlay launched in 2010. Out of more 20,000 implantations, 362 inlays have had to be removed due to customer complaints.
According to the FDA, the final indication is for who adults aged 45 to 60 years who have not had cataract surgery and need reading glasses with a power of +1 to +2.50 diopters, but not contacts or glasses for long-distance vision. Significantly, the recommendation that the patients do not need assistance with long-distance vision was not in AcuFocus' proposed indication to the FDA. In addition, the Kamra is contraindicated for several conditions, including severe dry eye, uncontrolled glaucoma and uncontrolled diabetes.
The FDA says the Kamra improves short-distance vision by blocking unfocused, peripheral light rays, and allows central ones to pass through a small 1.6 millimeter opening, or aperture, in the center to device.
"Presbyopia is a natural part of aging and can make reading and performing close-up work difficult," said Dr. William Maisel, deputy center director for science in the FDA's device arm (CDRH). "The Kamra inlay provides a new option for correcting near vision in certain patients."
The Kamra inlay's pivotal trial found that 83% of the 478 subjects saw improvement in short-distance vision that enabled them to read text in newspapers and magazine.
Privately held AcuFocus is based in Irvine, CA. It also sells the CE marked IC-8 intraocular lens and AcuTarget HD Instrument to help doctors select the best eye treatment option. Medtronic was one of the investors in the company's $21 million funding round, held in 2014.
The FDA decision comes on the heels of another PMA approval for Alcon's AcrySof IQ ReSTOR +2.5 Diopter Intraocular Lens.
- read the FDA's release