Bausch + Lomb announced that it has enrolled the first patient in a clinical trial studying the efficacy and safety of an investigational trifocal IOL, the enVista MX60EF. The study is intended to support a premarket approval (PMA) application filing with the FDA.
The enVista MX60EF trifocal IOL is a single-piece, ultra-violet absorbing posterior chamber IOL being developed to replace the natural crystalline lens in adult patients in whom the cataractous lens has been removed and who desire improved uncorrected near, intermediate and distance vision. Like the enVista MX60E, the enVista MX60EF IOL will feature StableFlex technology for rapid optic recovery following delivery. The enVista MX60EF trifocal IOL will also feature AccuSet haptics, which provides an offset design and broad contact angle, as well as the SureEdge design, which offers a continuous 360-degree square edge design.
“The initiation of this trial is an important milestone for our organization and another example of our commitment to investing in research and innovation,” Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb, said in a company news release. “We look forward to providing surgeons with another next-generation posterior chamber intraocular lens designed to meet their rapidly evolving needs.”
The multicenter, randomized clinical study will include more than 500 subjects undergoing bilateral cataract surgery. Subjects will receive either MX60EF trifocal IOLs or MX60E (enVista monofocal) IOLs. Investigators will determine efficacy endpoints after 6 months and safety endpoints after 12 months based on post-surgical observation.
Upon approval, enVista MX60EF trifocal IOL would become the latest addition to Bausch + Lomb’s enVista family of IOLs. Currently, there are no FDA approved trifocal IOLs available in the United States.