RxSight announced that the FDA has approved the RxSight Light Adjustable Lens and the Light Delivery Device for patients with pre-existing astigmatism of ≥0.75 D undergoing cataract surgery. This action ushers in a new era in the treatment of cataracts, as RxSight’s Light Adjustable Lens is the first and only FDA approved IOL that can be adjusted postoperatively to improve uncorrected visual acuity.
"Predictable and accurate refractive outcomes are essential to ensure patients are happy with their vision following cataract surgery,” Vance Thompson, MD, of Vance Thompson Vision in Sioux Falls, South Dakota, said in a company news release. “Until my work as an investigator in the phase 3 study of the Light Adjustable Lens, I had never encountered an IOL that consistently delivered the refractive accuracy that my premium cataract patients demand."
"Unfortunately, no matter what we do preoperatively with our measurements and mathematical calculations, the implant power is rarely perfect because of the variables of incision healing and the final effective lens position," Dr. Thompson said. "With the Light Adjustable Lens, we can address these limitations for the first time ever and more predictably deliver the results patients desire. Light adjustable implants will change the way we do cataract surgery forever, and I am thrilled that I will be able to finally deliver this level of care to my patients."
FDA approval was based on results of a U.S. randomized, pivotal study comparing the Light Adjustable Lens to a commercially available monofocal lens in 600 patients with pre-existing astigmatism at 17 investigational sites. Patients receiving the Light Adjustable Lens, followed by light treatment with the Light Delivery Device, achieved UCVA of 20/20 or better at 6 months postoperatively at approximately twice the rate of patients receiving a monofocal lens.
RxSight said that 91.8% of Light Adjustable Lens patients also achieved a result that was within 0.50 D of target manifest refraction spherical equivalent, which is similar to the refractive accuracy seen in recent LASIK studies. Study safety parameters were based on a comparison to the safety and performance endpoints for IOLs (ISO 11979 - 7), and results showed that 100% of study eyes had a best corrected visual acuity of 20/40 or better at the 6-month postoperative visit. The approved device allows correction of up to 2 D of postoperative sphere and/or -0.75 D to -2 D of residual postoperative refractive cylinder.
“We are extremely pleased to have successfully reached this milestone with the world’s first postoperative adjustable IOL," Eric Weinberg, Chief Commercial Officer, said in the news release. “This is an exciting opportunity for patients, surgeons and referring optometrists who have been awaiting a true breakthrough in refractive IOL technology. We are very grateful to all of those who have been involved in this effort, including the outstanding clinical coordinators, study investigators and their staff who facilitated the study, as well as the RxSight and FDA personnel who prepared and reviewed the regulatory submission."
RxSight has also received its CE mark for an expanded cylinder range (-0.5 to -3.00 D).
"In the near term, RxSight will focus on its post-market study, additional indications, platform improvements and building scalable infrastructure,” Mr. Weinberg said.