Bausch + Lomb says enVista Envy study meets end points

Executive Summary

• Bausch + Lomb announced the publication of pivotal U.S. clinical trial results for the enVista Envy, a novel full-visual-range intraocular lens (IOL), in The American Journal of Ophthalmology.
• The study demonstrated that enVista Envy met all primary efficacy and safety endpoints, showing statistical superiority over the enVista monofocal IOL for intermediate and near visual acuity.
• The trial involved 501 cataract patients and confirmed the lens's ability to provide continuous range of vision with excellent dysphotopsia tolerance and no serious adverse events related to the lens.

Key Details

• Study Design: Multicentre, prospective, masked, controlled trial published in The American Journal of Ophthalmology.
• Patient Population: 501 cataract patients randomized into two groups:
  • enVista Envy group: 332 patients (bilateral implantation).
  • enVista monofocal IOL (MX60E) group: 169 patients.
• Primary Efficacy Endpoints: Monocular corrected distance visual acuity (CDVA at 4 meters), distance-corrected intermediate visual acuity (DCIVA at 66 cm), and near visual acuity (DCNVA at 40 cm).
• Secondary Efficacy Metrics: Binocular DCIVA, DCNVA, uncorrected intermediate visual acuity (UIVA), and uncorrected near visual acuity (UNVA) measured postoperatively (days 120 to 180).
• Key Results:
  • Envy demonstrated non-inferiority for monocular CDVA.
  • Envy showed statistical superiority for monocular DCIVA and DCNVA compared to the monofocal group.
  • Envy group had significantly better binocular UIVA, DCIVA, UNVA, and DCNVA (all p < 0.0001).
  • Envy demonstrated consistent visual acuity of approximately 0.1 logMAR from -1.50 to -2.50 diopters.
  • Difference in mesopic contrast sensitivity (without glare) between groups was less than the minimum detectable difference of 0.15 logCS.
• Safety Results:
  • Met all primary safety end points.
  • No treatment-emergent serious adverse events related to the study lens.
  • No secondary surgical interventions due to the lens's optical properties.
  • No cumulative or persistent adverse events.
• Product Features:
  • Utilizes ActivSync Optic intelligent energy distribution for performance in various lighting conditions.
  • Toric IOL option allows for 0.50-diopter increments and treatment of under 1.0 diopter of corneal astigmatism (note: toric capabilities were not evaluated in this specific trial).

Notable Quotes

• "enVista Envy has been well received as the first premium IOL on the widely used enVista platform. Results of this study confirm the advantages that this lens offers -- continuous range of vision from distance to near with excellent dysphotopsia tolerance." — Luc Bonnefoy, President, Surgical, Bausch + Lomb
• "Trial results mirror what I have seen in my practice. 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." — Mitchell Shultz, Medical Director of Shultz-Chang Vision and Study Lead Author