Bausch + Lomb announce publication, positive topline results of enVista Envy trial data

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Bausch + Lomb announced results of the pivotal US clinical trial of the novel enVista Envy full visual range (FVR) intraocular lens (IOL).¹ The study, which compared visual, refractive, and patient-reported outcomes following implantation of enVista Envy and enVista monofocal IOL in cataract surgery patients, was published in the American Journal of Ophthalmology.²

“enVista Envy has been well-received as the first premium IOL on the widely used enVista Platform,” Luc Bonnefoy, president, Surgical, Bausch + Lomb, said in a press release.¹ “Results of this study confirm the advantages that this lens offers—continuous range of vision from distance to near with excellent dysphotopsia tolerance.”

The study was a multicenter, prospective, masked, controlled trial. A total of 501 cataract patients were randomized into two groups: one group received bilateral implantation of the enVista Envy (n=332), and the second group received the enVista monofocal IOL (MX60E) (n=169).^1,2

The primary efficacy endpoints included monocular corrected distance visual acuity (CDVA, 4m), distance-corrected intermediate (DCIVA, 66cm) and near (DCNVA, 40cm) visual acuity.^1,2 Binocular DCIVA, DCNVA uncorrected intermediate (UIVA), and near visual acuity (UNVA) postoperatively (day 120-180) were also measured.¹ Primary safety endpoints included adverse and serious adverse events, as well as surgical interventions related to the optical properties of the IOL through the same 120-180 day postoperative period.¹

“Trial results mirror what I have seen in my practice,” Mitchell Shultz, medical director, Shultz-Chang Vision in Northridge, CA, said in a press release. Shultz is the study’s lead author.¹

“I have long relied on the enVista platform, and I will continue to rely on Envy as an excellent option for cataract patients seeking an IOL that can provide a full range of vision with minimal visual disturbances, as well as precision astigmatism correction.”

Key study results:¹

• All primary efficacy endpoints were met. Envy demonstrated non-inferiority for monocular CDVA and statistical superiority for monocular DCIVA and DCNVA over the monofocal group.
• Better binocular UIVA, DCIVA, UNVA, and DCNVA were seen in the Envy group compared to the monofocal group.
• Envy demonstrated consistent visual acuity of ~0.1 logMAR from -1.50 to -2.50 D.
• There was less than the minimum detectable difference of 0.15 logCS in mesopic contrast sensitivity (without glare) between both groups.
• All primary safety endpoints were met. No treatment-emergent serious adverse events arose related to the study lens, as well as no secondary surgical interventions due to the lens’ optical properties, and no cumulative or persistent adverse events were seen.

Reference:

1. Bausch + Lomb Announced Publication of enVista Envy Full Range of Vision Intraocular Lens Pivotal US Clinical Trial. Published September 11, 2025. Accessed September 11, 2025. https://www.bausch.com/newsroom/news/?id=286

2. American Journal of Ophthalmology. Visual and patient-reported outcomes of a novel full visual range IOL versus a monofocal IOL: A randomized multicenter US trial. Published August 29, 2025. Accessed September 11, 2025. https://www.ajo.com/article/S0002-9394%2825%2900465-9/fulltext