Bausch and Lomb’s Intraocular Lenses One Step Closer to Market

On April 8, a U.S. Food and Drug Administration (FDA) ophthalmic devices panel convened to evaluate Bausch & Lomb Inc.’s Trulign Toric accommodating intraocular lenses (IOL). The implantable lenses are designed to reduce vision distortion and improve focus on both near and distant objects, especially after cataract surgery. The panel decided by a unanimous vote of 10-0 that the lenses are safe; 10-1 that the device is effective; and 10-1 that its benefits outweigh its risks. There were two panel members absent for the vote.

FDA reviewers had earlier said the study had 401 protocol deviations, 24 of which impacted data analysis, which could cast doubt on the study’s ability to demonstrate that the benefit from the lens outweighed the risk. However, the vote demonstrated that the panel deemed these deviations to be insignificant to the benefits of the lens.

STAAR Surgical Co. and Novartis unit Alcon lab Inc. (a Novartis unit) both market implantable lenses that correct astigmatism after cataract surgeries. If the Toric lens is granted FDA approval, it will be the first implantable lens to correct astigmatism while also allowing patients to automatically focus on objects. Trulign Toric is a modification to the currently approved Crystalens Five-O IOL, with the only difference being that Trulign is an incorporated toroidal (donut shaped) posterior optic surface, according to the agency.

Bausch & Lomb, which makes eye health products and is based in Rochester, N.Y., already has an implantable lens in the market, which uses the eye muscles to focus on objects.

According to FDA, “Trulign Toric provides approximately 1 diopter of monocular accommodation, which allows for near, intermediate, and distance vision without spectacles.”

“The vast majority of available IOLs are monofocal,” reads the Trulign Toric patient information brochure from the FDA. “It is a technology that has been used successfully for decades. Monofocal toric IOLs are one option for correcting corneal astigmatism and distance vision after cataract surgery to provide clear vision at one focal point, usually distance vision. In most cases, however, the patient still needs to wear glasses or contact lenses to see images within their near field of vision and sometimes for those in the intermediate field of vision, as well. There are other IOLs to choose from for distance vision, but some are not designed to correct astigmatism.”

The clinical study for the lens included 229 patients, 227 of whom received a lens implant in one eye. According to the FDA brochure, 85 percent of the cases involving astigmatism that the surgeon intended to correct were remedied; 100 percent of patients implanted with Trulign Toric IOL could pass a drivers’ test without glasses whereas only 75 percent of patients who were implanted with a non-toric lens could pass a drivers’ test.