Bausch + Lomb Receives European CE Mark Approval for Preloaded LuxLife® Full Range of Vision Intraocular Lens
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VAUGHAN, Ontario — Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced CE Mark approval for the LuxLife full range of vision intraocular lens (IOL). The preloaded IOL provides patients with natural, continuous vision, from distance to near. Today's announcement reinforces Bausch + Lomb's commitment to equip cataract surgeons with choices to fit the right lens to the right patient following the recent launches of enVista ® Envy™ full range of vision lenses in the United States and Canada and enVista Aspire™ intermediate-optimized IOLs in Europe.
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'This platform has delivered both quality of vision and patient satisfaction since its introduction,' said Luc Bonnefoy, president, Surgical, Bausch + Lomb. 'LuxLife is an example of how we plan to build on that success by developing premium options designed to meet the evolving needs of surgeons and patients.'
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In a multicenter, comparative clinical study evaluating the LuxLife IOL versus the monofocal LuxGood ® IOL, patients experienced excellent binocular visual outcomes with LuxLife at all distances, near, intermediate and far. 1 The LuxLife lens also delivered a high level of patient satisfaction with 95.6% of patients reporting spectacle independence at intermediate distance and 89.5% at near. 1
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With Pure Refractive Optics (PRO) Technology, this non-diffractive IOL has an uninterrupted, continuous refractive surface across the entire optical diameter. LuxLife also features two unique Allied Ray Technology (ART) Zones which control and refocus light rays. Together, PRO Technology and ART Zones ensure LuxLife does not lose any light to the retina, unlike diffractive full range of vision IOLs.
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With a broad range of cylinders, from +0.75D to +6.00D, the LuxLife IOL enables surgeons to treat the 79.5% of patients with more than 0.5D of corneal astigmatism prior to cataract surgery. 2 During implantation, surgeons can easily select their preferred injection technique with the preloaded LuxLife lens' versatile dual injector system.
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'The LuxLife lens provides truly multifocal optical performance, offering an extensive range of clear vision from distance to near,' noted Francisco Javier Castro Alonso, MD, PhD, UFR-Miguel Servet University Hospital, Zaragoza, Spain, an investigator in the multicenter clinical study. 'I consider this lens a first-choice option for patients seeking freedom from glasses at all distances.'
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LuxLife IOLs will be commercially available in Europe in the coming weeks, followed closely by a toric version of the lens. Submissions for regulatory approvals in other countries are ongoing.
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About Bausch + Lomb
Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from birth through every phase of life. Its comprehensive portfolio of approximately 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,500 employees and a presence in approximately 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario, with corporate offices in Bridgewater, New Jersey. For more information, visit www.bausch.com and connect with us on X, LinkedIn, Facebook and Instagram.
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References:
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CE Mark study report CE2001_CIR_V2.0_20241220 (Multicentric Clinical Study to Determine Safety and Efficacy of a Hydrophobic Acrylic Trifocal Intraocular Lens (IOL) NCT04465344)
de Bernardo, M., Zeppa, L., Cennamo, M., Iaccarino, S., Zeppa, L., & Rosa, N. (2013). Prevalence of corneal astigmatism before cataract surgery in Caucasian patients. European Journal of Ophthalmology, 24 (4), 494–500. https://doi.org/10.5301/ejo.5000415
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