Dive Brief:
- Bausch + Lomb has received a CE mark for its Luxlife intraocular lens, the company said Wednesday.
- The CE mark positions Bausch + Lomb to make the lens, which supports near, intermediate and far vision, in Europe in the coming weeks.
- Bausch + Lomb’s range of Lux lenses is based on a different platform than its Envista IOLs. Some Envista lenses were recently recalled in the U.S. but returned to the market weeks later after the company identified a raw material from a vendor as the cause of inflammatory reactions.
Dive Insight:
Yehia Hashad, chief medical officer at Bausch + Lomb, discussed the differences between Lux and Envista lenses on the company’s earnings call in April. Hashad said Lux lenses have a “slightly different platform than the Envista because they use a different optical design diffractive technology.”
Bausch + Lomb said the non-diffractive Luxlife lenses feature two technologies to ensure the IOL does not lose any light to the retina. Light loss affects diffractive full range of vision IOLs, the company said.
The CE mark was supported by a clinical trial run by Cutting Edge, a French developer of IOLs. The trial compared the trifocal Luxlife IOL to the monofocal Luxgood lens. Bausch + Lomb said recipients of Luxlife had excellent binocular visual outcomes at all distances. At near and intermediate distances, respectively 89.5% and 95.6% of Luxlife users reported being able to see without glasses.
Bausch + Lomb plans to make a non-toric version of the lens available in the coming weeks. The launch will be followed closely by the rollout of a toric version of the lens, a design used to correct astigmatism.
Speaking on an earnings call last month, Bausch + Lomb CEO Brent Saunders included the Luxlife launch on a list of upcoming milestones. Saunders said Bausch + Lomb was planning “a soft launch for Envista Envy in Europe later this year with the full rollout expected in early 2026.” Envista Envy was one of the devices Bausch + Lomb recalled over inflammatory reactions.
