Bausch + Lomb says enVista Envy study meets end points

Mr. Luc Bonnefoy reports BAUSCH + LOMB ANNOUNCES PUBLICATION OF ENVISTA ENVY FULL RANGE OF VISION INTRAOCULAR LENS PIVOTAL U.S. CLINICAL TRIAL The American Journal of Ophthalmology has published results of Bausch + Lomb Corp.'s pivotal U.S. clinical trial of the enVista Envy novel full-visual-range intraocular lens. The study compared visual, refractive and patient-reported outcomes following implantation of enVista Envy and the enVista monofocal IOL in cataract surgery patients. "enVista Envy has been well received as the first premium IOL on the widely used enVista platform," said Luc Bonnefoy, president, surgical, Bausch + Lomb. "Results of this study confirm the advantages that this lens offers -- continuous range of vision from distance to near with excellent dysphotopsia tolerance." In the multicentre, prospective, masked, controlled trial, investigators randomized 501 cataract patients into two groups, one of which received bilateral implantation of the enVista Envy (n equal to 332) while the other received the enVista monofocal IOL (MX60E) (n equal to 169). Primary efficacy end points included monocular corrected distance visual acuity (CDVA, four metres), distance-corrected intermediate visual acuity (DCIVA, 66 centimetres) and near (DCNVA, 40 centimetres) visual acuity. Investigators also measured binocular DCIVA, DCNVA uncorrected intermediate (UIVA) and near visual acuity (UNVA) postoperatively (days 120 to 180). Primary safety end points included adverse events and serious adverse events as well as surgical interventions related to the optical properties of the IOL through the same postoperative period. Key results: The study met all primary efficacy end points, with Envy demonstrating non-inferiority for monocular CDVA and statistical superiority for monocular DCIVA and DCNVA over the monofocal group. The Envy group also had better binocular UIVA, DCIVA, UNVA and DCNVA compared with the monofocal group (all p less than 0.0001). Envy demonstrated consistent visual acuity of approximately 0.1 logMAR from minus 1.50 to minus 2.50 diopters. The difference in mesopic contract sensitivity (without glare) between the two groups was less than the minimum detectable difference of 0.15 logCS. The study met all primary safety end points, with no treatment-emergent serious adverse events related to the study lens, no secondary surgical interventions due to the lens's optical properties, and no cumulative or persistent adverse events. "Trial results mirror what I have seen in my practice," said Mitchell Shultz, medical director of Shultz-Chang Vision in Northridge, Calif., and the study's lead author. "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." enVista Envy delivers outstanding performance in all lighting conditions thanks to ActivSync Optic intelligent energy distribution, which optimizes vision in many lighting conditions. Although not evaluated in this trial, the Envy toric IOL allows surgeons to address a broader range of astigmatic patients with greater accuracy and precision, offering 0.50-diopter increments and the ability to treat under 1.0 diopter of corneal astigmatism. About Bausch + Lomb Corp. Bausch + Lomb's mission is simple -- the company helps people see better to live better, all over the world. For nearly two centuries, Bausch + Lomb has evolved with the changing needs of patients and customers, and the company's commitment to innovation and improving the standard of care in eye health has never been stronger. From contact lenses to prescription products, over-the-counter options, surgical devices and more, Bausch + Lomb is turning bold ideas into better outcomes through passion, perseverance and purpose.