Bausch + Lomb publishes enVista Envy trial results

Bausch + Lomb (BLCO) announced that the American Journal of Ophthalmology has published results of the 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. In the multicenter, prospective, masked, controlled trial, investigators randomized 501 cataract patients into two groups, one of which received bilateral implantation of the enVista Envy while the other received the enVista monofocal IOL. Primary efficacy endpoints included monocular corrected distance visual acuity, distance-corrected intermediate and near visual acuity. Investigators also measured binocular DCIVA, DCNVA uncorrected intermediate, and near visual acuity postoperatively. Primary safety endpoints 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. The study met all primary efficacy endpoints, 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 to the monofocal group. Envy demonstrated consistent visual acuity of ~0.1 logMAR from -1.50 to -2.50 D. The difference in mesopic contract sensitivity between the two groups was less than the minimum detectable difference of 0.15 logCS. The study met all primary safety endpoints, with no treatment-emergent serious adverse events related to the study lens, no secondary surgical interventions due to the lens’ optical properties and no cumulative or persistent adverse events.