FDA Approves RxSight’s Light Adjustable Lens, Opening New Treatment Protocol for Cataracts

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ALISO VIEJO, Calif.—RxSight Inc. reported this week that the FDA has approved its Light Adjustable Lens and the Light Delivery Device (LDD) for treating certain patients post-cataract surgery.

According to the FDA’s approval announcement, this is “the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.”

RxSight noted that the FDA’s approval “ushers in a new era in the treatment of cataracts,” since its Light Adjustable Lens is the first and only FDA-approved intraocular lens (IOL) “that can be adjusted post-operatively to improve uncorrected visual acuity.”

“Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery,” Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat at the FDA’s Center for Devices and Radiological Health, stated in the FDA’s approval notice. “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.”

According to the FDA, the RxSight IOL is made of a unique material that reacts to UV light, which is delivered by the Light Delivery Device, 17 to 21 days after surgery. Patients receive three or four light treatments over a period of 1 to 2 weeks, each lasting about 40 to 150 seconds, depending upon the amount of adjustment needed. The patient must wear special eyeglasses for UV protection from the time of the cataract surgery to the end of the light treatments to protect the new lens from UV light in the environment.

“We are extremely pleased to have successfully reached this milestone with the world’s first post-operative adjustable IOL,” Eric Weinberg, chief commercial officer at RxSight, said in the company’s statement. “This is an exciting opportunity for patients, surgeons and referring optometrists who have been awaiting a true breakthrough in refractive IOL technology.”

Vance Thompson, MD, of Vance Thompson Vision in Sioux Falls, S.D., and an investigator in the Phase III study, said in the announcement: “Predictable and accurate refractive outcomes are essential to ensure patients are happy with their vision following cataract surgery. Until my work as an investigator in the Phase III study of the Light Adjustable Lens, I had never encountered an IOL that consistently delivered the refractive accuracy that my premium cataract patients demand.”