FDA Issues Approval for Bausch + Lomb's Multifocal Contact Lens for Astigmatism


BRIDGEWATER, N.J.—Bausch + Lomb, a global eye health company, said Wednesday that the Food and Drug Administration (FDA) has issued 510(k) clearance for Bausch + Lomb Ultra Multifocal for Astigmatism contact lenses. This is the first multifocal toric lens to be available as a standard offering in the eyecare professional's fit set, according to the announcement. The lens is the “most advanced soft contact lens design in the history of Bausch + Lomb,” according to the announcement, and the monthly silicone hydrogel lens “builds upon the success of Bausch + Lomb Ultra for Presbyopia and Bausch + Lomb Ultra for Astigmatism lenses.”

Bausch + Lomb is a wholly owned subsidiary of Bausch Health Companies Inc. (NYSE/TSX: BHC).

“Eyecare professionals have routinely stressed the need to have a readily available contact lens that addresses both presbyopia and astigmatism, underscoring the critical vision needs of this growing patient population,” Joe Gordon, U.S. president, Bausch + Lomb, said in the announcement. “Our in-house team of scientists and contact lens designers developed Bausch + Lomb Ultra Multifocal for Astigmatism to provide patients a lens with excellent comfort and vision that can be fit during the initial contact lens exam.”

The news lens will be available to ECPs and their patients by mid-2019, Gordon added.

The vast majority of all adults ages 40 or older currently wear some type of vision correction, with nearly one-third of those being astigmatic, according to the announcement. Previously, ECPs who decided to move forward with a multifocal toric lens fitting for these patients were unable to do so during the initial visit, and they were required to special order the lenses and schedule a follow-up appointment for a fitting, the company noted.

With this new lens, ECPs will have the ability to immediately fit patients with these lenses as a standard offering in the fitting set, the company said.

Gina Wesley, OD, of Complete Eye Care of Medina, Minn., said that as the population of astigmatic patients with presbyopia grows, the availability of a comfortable and convenient option to help this population of patients is critical. “I believe these new Bausch + Lomb Ultra Multifocal for Astigmatism lenses will not only deliver on these benefits by providing these patients a same-day fitting option that addresses their presbyopia and astigmatism, but also offer a unique differentiator in my practice with the reliability of a trusted brand,” Wesley said in the announcement.