FDA approves enVista Envy IOL from Bausch + Lomb
The enVista Envy IOL offers a full range of vision, and 86% of patients in clinical trial reported little or no trouble with dysphotopsia.
Image credit: Adobe Stock/©wladimir1804
Bausch + Lomb announced FDA approval of its latest enVista intraocular lens (IOL), the Envy full range of vision IOL. The Envy offers a continuous range of vision that promotes dysphotopsia tolerance, according to the company.1 The lens demonstrated excellent long-term outcomes in US-based clinical trials as well as Canadian studies, and leverages ActivSync Optic intelligent energy distribution to perform well in all lighting conditions.2,3 The enVista Envy was previously approved by Health Canada in May of 2024.
“Optometrists play an important role in educating their patients on visual acuity options, and patients put a great deal of trust in their recommendations,” said Anthony Wallace, vice president and general manager of US surgical at Bausch + Lomb. “enVista Envy provides them with a premium option that they can feel confident will give their patients a positive experience - delivering the near, intermediate and distance vision they are looking for with minimal visual disturbances.”
The Envy IOL performed well in both US and Canadian clinical trials. In the US trial, investigators evaluated 332 subjects, of which, an average of 86% of patients reported little to no discomfort related to glare, halo, starbursts, or other forms of dysphotopsia.2 The Canadian study evaluated 110 subjects, with 94% of patients reporting excellent near acuity and 93% of patients said they were moderately to completely satisfied with their post-operative vision.3
The lens is indicated for toric and non-toric use, though the enVista Envy Toric IOL has not undergone clinical study. Both lenses are indicated for implantation in the capsular bag for visual correction of aphakia. The non-toric lens is indicated to correct 1.0 diopter (D) or less of preoperative corneal astigmatism while the toric hydrophobic acrylic IOL will treat higher levels of astigmatism in post-cataract eyes. The intent is to lessen the effects of presbyopia by improving intermediate and near visual acuity without sacrificing distance acuity that is typically achieved in an aspheric monofocal IOL.1
Bausch + Lomb boasts of allowing surgeons to treat astigmatism with more accuracy and precision due to the Envy IOL’s 0.5 D steps or less throughout the cylinder range. Bausch + Lomb also shares that the Envy IOL delivers “outstanding performance in all lighting conditions,” due to its proprietary ActivSync Optic intelligent energy distribution.
“I’ve long trusted the enVista platform to deliver excellent outcomes for my cataract patients,” Alice Epitropoulos, MD, Ophthalmic Surgeons & Consultants of Ohio and principal investigator in the Phase 3 US clinical trial, said in a press release.1 “I expect that having a lens on the same platform that offers a full range of vision with minimal visual disturbances, as well as a toric option for precision astigmatism correction, will significantly enhance my ability to achieve that goal.”
Bausch + Lomb is rolling out enVista Envy IOLs slowly, with lenses becoming commercially available in the US on a limited basis in the coming weeks, with a broader rollout in 2025. The company continues to seek regulatory approvals in additional markets around the globe.
