Bausch + Lomb Secures CE Mark Approval for LuxLife Full Range of Vision Intraocular Lens in Europe
核心洞察
Bausch + Lomb (搜索) has received European CE Mark approval for its LuxLife (搜索) full range of vision intraocular lens (搜索), providing patients with natural, continuous vision from distance to near following cataract (搜索) surgery.
Clinical studies demonstrated excellent visual outcomes with 95.6% of patients reporting spectacle independence at intermediate distance and 89.5% at near, positioning LuxLife (搜索) as a premium option for cataract (搜索) patients.
The non-diffractive IOL features Pure Refractive Optics (搜索) Technology and Allied Ray Technology (搜索) Zones, with a broad range of cylinders to treat the 79.5% of patients with corneal astigmatism (搜索) prior to cataract (搜索) surgery.
Bausch + Lomb (搜索) Corporation (NYSE/TSX: BLCO) announced today it has received European CE Mark approval for its LuxLife (搜索) full range of vision intraocular lens (搜索) (IOL). The preloaded IOL is designed to provide patients with natural, continuous vision from distance to near following cataract (搜索) surgery.
The approval strengthens Bausch + Lomb (搜索)'s expanding portfolio of premium IOL options, following the recent launches of enVista Envy (搜索) full range of vision lenses in the United States and Canada, and enVista Aspire (搜索) intermediate-optimized IOLs in Europe.
"This platform has delivered both quality of vision and patient satisfaction since its introduction," said Luc Bonnefoy, president, Surgical, Bausch + Lomb (搜索). "LuxLife (搜索) 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."
Clinical Performance and Patient Satisfaction
A multicenter, comparative clinical study evaluated the LuxLife (搜索) IOL against the monofocal LuxGood (搜索) IOL. Results demonstrated that patients experienced excellent binocular visual outcomes with LuxLife at all distances—near, intermediate, and far. The lens also achieved high patient satisfaction rates, with 95.6% of patients reporting spectacle independence at intermediate distance and 89.5% at near.
Francisco Javier Castro Alonso, MD, PhD, from UFR-Miguel Servet University Hospital in Zaragoza, Spain, who served as an investigator in the multicenter clinical study, noted: "The LuxLife (搜索) lens provides truly multifocal optical performance, offering an extensive range of clear vision from distance to near. I consider this lens a first-choice option for patients seeking freedom from glasses at all distances."
Advanced Optical Technology
The LuxLife (搜索) IOL incorporates several innovative technologies that distinguish it from traditional options:
- Pure Refractive Optics (PRO) Technology: This non-diffractive IOL features an uninterrupted, continuous refractive surface across the entire optical diameter.
- Allied Ray Technology (ART) Zones: Two unique zones control and refocus light rays.
- Light Efficiency: The combination of PRO Technology and ART Zones ensures LuxLife does not lose any light to the retina, unlike diffractive full range of vision IOLs.
Addressing Astigmatism and Surgical Flexibility
With a broad range of cylinders from +0.75D to +6.00D, the LuxLife (搜索) IOL enables surgeons to treat the 79.5% of patients with more than 0.5D of corneal astigmatism (搜索) prior to cataract (搜索) surgery. The preloaded design features a versatile dual injector system, allowing surgeons to easily select their preferred injection technique during implantation.
Market Availability
According to Bausch + Lomb (搜索), LuxLife (搜索) IOLs will be commercially available in Europe in the coming weeks, with a toric version of the lens to follow shortly thereafter. The company is also pursuing regulatory approvals in other countries.
Cataract Surgery and IOL Market Context
Cataract (搜索) surgery is one of the most common surgical procedures worldwide, with an estimated 28 million procedures performed annually. As the global population ages, demand for premium IOLs that can reduce or eliminate the need for glasses after surgery continues to grow.
Traditional monofocal IOLs typically provide clear vision at only one distance, usually far, requiring patients to use reading glasses for near vision tasks. Full range of vision IOLs like LuxLife (搜索) aim to provide clear vision across all distances, potentially eliminating the need for glasses altogether.
About Bausch + Lomb
Founded in 1853, Bausch + Lomb (搜索) is dedicated to protecting and enhancing vision for millions of people worldwide. The company's portfolio includes approximately 400 products spanning contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products, and ophthalmic surgical devices and instruments.
With approximately 13,500 employees and a presence in about 100 countries, Bausch + Lomb (搜索) maintains its headquarters in Vaughan, Ontario, with corporate offices in Bridgewater, New Jersey.