California medical device maker Bausch + Lomb announced today that it won FDA approval for its 1st-of-its-kind Trulign Toric intraocular lens.
The regulatory approval grants B+L permission to market the lens in the U.S. for treatment of astigmatism as well as improving vision across a natural range of focus without the use of glasses.
"The new Trulign Toric lens is the latest in a long line of innovations from Bausch + Lomb for cataract patients," chief medical officer and executive vice president Dr. Calvin Roberts said in prepared remarks. "Bausch + Lomb’s Trulign Toric intraocular lens represents a significant step forward in intraocular lens technology, providing predictable astigmatism correction combined with improved visual acuity for an active lifestyle."
The FDA approval follows last month’s recommendation by an FDA advisory panel who voted 10-1 with 1 abstention that the device’s benefits outweighs its risks.
The lens is designed for implantation the capsular bag of the eye in order to replace a surgically removed lens following cataract surgery and to correct post-operative refractive astigmatism. Bausch + Lomb claims that Trulign Toric provides "approximately 1 diopter of monocular accommodation, which allows for near, intermediate, and distance vision without spectacles."
Bausch + Lomb did not immediately respond to requests for comment.