The FDA has cleared RxSight‘s implantable light adjustable intraocular lens and light delivery device.
The company’s RxSight IOL is designed from a UV light reactive material meant to be treated by a specific Light Delivery Device, intended for use 17 to 21 days post-procedure.
The lens is designed to be treated by 3-4 light treatments over 1 to 2 weeks in 40 to 150 second treatment periods, during which the patient must wear UV-protective glasses.
“Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery. This system provides a new option for certain patients that allows the physician to make small adjustments to the implanted lens during several in-office procedures after the initial surgery to improve visual acuity without glasses,” FDA Center for Devices and Radiological Health Division of Ophthalmic, and Ear, Nose and Throat director Dr. Malvina Eydelman said in a press release.
Approval came based off a 600 patient study of the system which aimed to evaluate the safety and effectiveness of the RxSight system, which reported an average improvement of one additional line down the vision chart after 6 months without glasses when compared to traditional IOLs.
A total of 75% of the patients in the trial reported a reduction in astigmatism as well, according to an FDA release.