EyeWorld Weekly Update, December 1, 2017

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December 1, 2017
Volume 23 , Number 41

FDA approves Light Adjustable Lens and delivery device

The U.S. Food and Drug Administration (FDA) approved the Light Adjustable Lens (LAL) and the Light Delivery Device (RxSight, Aliso Viejo, California). They are part of the first medical device system that can make small adjustments to the artificial lens' power after cataract surgery so the patient will have better vision without glasses, according to an FDA news release. "This system provides a new option for certain patients that allows the physician to make small adjustments to the implanted lens during several in-office procedures after the initial surgery to improve visual acuity without glasses," said Malvina Eydelman, MD, director, Division of Ophthalmic and Ear, Nose and Throat Devices, Center for Devices and Radiologic Health, FDA. In a study of the LAL and delivery device among 600 patients, there was an average improvement of one additional line on the vision chart for distance vision at 6 months postoperatively. There was also a reduction in astigmatism in 75% of patients.

Phase 3 trial for pediatric myopia treatment enrolls first patient

A Phase 3 trial for NVK-002 (Nevakar, Bridgewater, New Jersey), designed to slow myopia progression in children, enrolled its first subject in November. The number of people with high myopia is expected to reach more than 900 million by the year 2050. The Phase 3 trial is expected to include 500 subjects between ages 3 and 17 who have a myopia spherical equivalent refraction of at least -0.50 D and no more than -6 D in each eye. The first stage of the randomized, multicenter, double-masked, placebo-controlled trial will focus on the safety and efficacy of low dose and high dose concentrations of NVK-002 compared with placebo over a 3-year period. Stage 2 will be a 1-year randomized crossover phase. There is no FDA-approved eye drop currently available to treat or slow advancement of the disease.

Phase 3 trial halted for combined aflibercept injection and nesvacumab for DME, AMD

Based on the results of two Phase 2 studies adding angiopoietin2 antibody nesvacumab to aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York) for the treatment of diabetic macular edema (DME) and wet age-related macular degeneration (AMD), the company concluded that there was not sufficient differentiation to continue to a Phase 3 trial. One study, called RUBY, focused on patients with DME, while the ONYX study evaluated patients with AMD. Both were randomized, double-masked, active-controlled Phase 2 studies focusing on whether the combination of aflibercept and nesvacumab offered benefits over monotherapy with aflibercept. The primary endpoint in both RUBY and ONYX was a change in best corrected visual acuity between weeks 12 and 35 as measured by an Early Treatment Diabetic Retinopathy Study letter score. Results from RUBY and ONYX will be further analyzed and submitted for presentation at future medical meetings. The combination therapy of aflibercept and nesvacumab is under joint development by Regeneron and Bayer (Leverkusen, Germany).

RESEARCH BRIEFS

  • With the aging of the population, an increasing number of people are affected by vision loss, according to an analysis of vision loss data from 1990 to 2015 led by Seth Flaxman, PhD, and co-researchers. Their systematic review analyzed published and unpublished population-based data for the causes of vision impairment and blindness and identified 288 studies including 3.98 million participants, with data from 98 countries. The leading causes of moderate or severe vision impairment in 2015 were uncorrected refractive error (116.3 million), cataract (52.6 million), AMD (8.4 million), glaucoma (4 million), and diabetic retinopathy (2.6 million). Among those who were blind, the leading causes were cataract (12.6 million), uncorrected refractive error (7.4 million), and glaucoma (2.9 million). In 2015, cataract and uncorrected refractive error combined contributed to 55% of blindness and 77% of vision impairment in those who were age 50 or older. The researchers predicted that by 2020, the number of people affected by uncorrected refractive error would rise to 127.7 million, by cataract to 57.1 million, by AMD to 8.8 million, by glaucoma to 4.5 million, and by diabetic retinopathy to 3.2 million. The research appears in The Lancet Global Health.
  • The presence of late AMD, bilateral cataract surgery, and a visual acuity of less than 20/40 was associated with decreased survival in an analysis of data from the Age-Related Eye Disease Study 2 (AREDS2). The AREDS2 Research Group Writing Committee focused on the association of mortality with visual acuity impairment, AMD, and cataract surgery. Participants had at least intermediate AMD and were part of a randomized controlled clinical trial of lutein/zeaxanthin and/or omega-3 fatty acids. Within a median follow-up of 5 years, 9% of the 4,203 AREDS2 participants died. There was a statistically significantly increased mortality risk in patients with neovascular AMD in one eye at baseline compared with those who had no or few drusen. Those with bilateral cataract surgery before enrollment also had poorer survival, as did those with a best corrected visual acuity of less than 20/40. Participants receiving antivascular endothelial growth factor therapies for neovascular AMD had a lower mortality than those who did not. There was no significant impact on mortality with oral supplementation with omega-3 fatty acids, lutein plus zeaxanthin, zinc, or beta carotene. The study is published in Ophthalmology.
  • A prospective case study that used functional magnetic resonance imaging (MRI) to help neuroadaptation to multifocal IOLs found that neuroadaptation initially occurred through the recruitment of visual attentional and procedural learning networks. Afterward, a form of long-term adaptation/functional plasticity took place, which led to brain activity regularization toward a non-effort pattern. Led by Andreia Rosa, MD, researchers focused on 30 patients with bilateral diffractive IOL implantation after cataract surgery who had functional MRIs at 3 weeks and 6 months postop. A nonintervention control group (15 patients) was also included. Glare was lower for the functional MRI signal measured for sinusoidal gratings at 3 weeks but not at 6 months, a finding that was confirmed by contrast detection under glare improvement. There was increased activity of cortical areas that are part of visual attention, procedural learning, effortful cognitive control, and goal-oriented behavior in the early postop period. No changes were observed in the control group. The study appears in the Journal of Cataract & Refractive Surgery.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Eric Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara Chan, MD, cornea editor; Reay Brown, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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