Study Intended to Support FDA Pre-Market Approval (PMA) Filing
BRIDGEWATER, N.J., June 4, 2018 – Bausch + Lomb, a leading global eye health company, announced today that it has enrolled the first patient in a clinical trial studying the efficacy and safety of an investigational trifocal intraocular lens (IOL), the enVista® MX60EF. The study is intended to support a Pre-Market Approval (PMA) application filing with the U.S. Food and Drug Administration (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,” said Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb. “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 six months and safety endpoints after 12 months based on post-surgical observation.
“As a cataract surgeon, I understand the increasing demand among patients for improved uncorrected near, intermediate and distance vision after surgery, and the desire to have options that can deliver on this outcome,” said Mark Packer, M.D., lead enVista MX60EF study investigator and ophthalmologist, Boulder, CO. “I look forward to participating in this study, as it’s an exciting opportunity to evaluate this new trifocal candidate.”
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 U.S.
About Bausch + Lomb
Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing, and restoring people’s eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. We develop, manufacture and market one of the most comprehensive product portfolios in our industry with products available in more than 100 countries.
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