EyeWorld Weekly Update, September 1, 2017

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September 1, 2017
Volume 23 , Number 30

First human clinical study for Orion system to begin

The U.S. Food and Drug Administration has given Second Sight Medical Products (Sylmar, California) conditional approval to test its Orion cortical visual prosthesis system in humans in a feasibility clinical study. The study will be able to enroll up to five patients at two U.S. sites, University of California, Los Angeles and Baylor College of Medicine, Houston. The idea behind Orion, according to a Second Sight press release, is to convert images captured by a miniature video camera on the patient's glasses into a series of small electrical pulses. The Orion then transmits the electrical pulses wirelessly to electrodes implanted on the visual cortex surface, which is intended to result in the perception of light patterns. The system bypasses the retina and optic nerve and may potentially restore blindness due to glaucoma, diabetic retinopathy, or forms of cancer and trauma, according to the company. Second Sight is also the maker of the Argus II Retinal Prosthesis System.

Primary endpoint met in Phase 2 study of patients with geographic atrophy

The complement C3 inhibitor APL-2 med its primary endpoint in FILLY, a Phase 2 trial for patients with geographic atrophy associated with age-related macular degeneration (AMD), according to a press release from Apellis Pharmaceuticals (Louisville, Kentucky). APL-2 showed a 29% reduction in the rate of geographic atrophy lesion growth compared to sham at 12 months. With bimonthly administration, a 20% reduction was observed. Study researchers found a greater effect during the second 6 months of the study; there was a 47% reduction in growth rate with monthly administration and a 33% reduction with bimonthly administration. There was a higher rate of exudative AMD in the treatment groups, mostly in subjects with a history of exudative AMD in the fellow eye; this was managed with standard of care therapies. The FILLY trial includes 246 patients and is a multicenter, randomized, single-masked, sham-controlled trial of APL-2 in patients with geographic atrophy at 40 sites in the U.S., Australia, and New Zealand.

Two-year outcomes with as-needed aflibercept for DME reported

Aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York) retreatment was significantly reduced in the fourth and fifth years of dosing for diabetic macular edema (DME) after therapy commenced in the Study of Intravitreal Aflibercept Injection in Patients With Diabetic Macular Edema (VISTA DME), according to Charles Wykoff, MD, and co-researchers. Visual gains were achieved during the 3-year VISTA DME trial through the Long-Term Efficacy and Safety of Intravitreal Aflibercept for the Treatment of DME in Subjects Who Completed the VISTA DME Trial (ENDURANCE) extension study, and there was a reduced treatment burden. Clinically relevant worsening of diabetic retinopathy was seen with progression to proliferative diabetic retinopathy in 10% of eyes. Sixty patients who participated in VISTA DME enrolled in ENDURANCE, the Phase 4, 2-year, open-label extension study reported here. The main outcome was mean aflibercept injections given over 2 years; disease activity determined intervals between visits. The research is published in the British Journal of Ophthalmology.

RESEARCH BRIEFS

  • The number of patients with dry eye in real life settings who are slated to undergo cataract surgery is higher than anticipated, according to a study led by William Trattler, MD. Researchers aimed to analyze dry eye incidence and severity as determined by the International Task Force scale in patients screened for cataract surgery. Their prospective, multicenter, observational study included 136 patients who were at least 55 years old and scheduled for cataract surgery. The primary outcome measure was dry eye incidence as evaluated by grade on the International Task Force scale. Nearly 63% of patients had a tear break-up time of 5 seconds or less; 77% of eyes had positive corneal staining, and 50% had positive central corneal staining. A Schirmer's score with anesthesia of 5 mm or less was seen in 18% of patients. The study appears in Clinical Ophthalmology.
  • The timing of repositioning surgery and surgical outcome was a significant factor in correcting the misalignment of acrylic foldable toric IOLs, reported Tetsuro Oshika, MD, and co-researchers in a retrospective, multicenter case series. They analyzed patients who had phacoemulsification and toric IOL implantation at eight surgical sites. In 6,431 eyes with toric IOLs, 0.653% required repositioning surgery at a mean of 9.9 days after IOL implantation. Repositioning surgery significantly reduced misalignment from 32.9 degrees to 8.8 degrees on average, measured at 7.6 weeks postop. Refractive cylinder significantly reduced from 2.4 D to 1.1 D. A significant negative correlation between the interval from cataract surgery to repositioning procedure and the degree of residual misalignment was found. Residual misalignment was 13.1 degrees when repositioning was performed within 6 days after cataract surgery compared with 6.3 degrees when the IOL was repositioned 7 days or later. The numbers suggest that repositioning surgery should be done 1 week after IOL implantation, the researchers concluded. Their study appears in Ophthalmology.
  • The benefits of aspirin use to promote cardiovascular health outweigh the smaller and conflicting studies that suggest an adverse effect of aspirin use on the development of AMD, according to Kent Small, MD, and co-researchers. Their literature review critically analyzed six cardiovascular and four ophthalmology trials, all of which were focused on the risks and benefits of aspirin use. The cardiovascular trials had a total of 167,580 subjects compared with 12,015 subjects in the ophthalmology trials. There was a significant 32% reduction in the risk of nonfatal stroke with regular aspirin users; fatal vascular deaths decreased by 15%. All of the prospective randomized trials within ophthalmology suggested an exacerbation of AMD without statistical significance and broad confidence bands. The occurrence of AMD can be reasonably controlled with anti-vascular endothelial growth factor therapy, they added. The research appears in Retina.
  • In eyes with open-angle glaucoma (OAG), the reduction in IOP after cataract surgery was greater in eyes with narrower angles, reported Yen Hsia, MD, and co-researchers. They aimed to evaluate IOP change after cataract surgery in eyes with OAG and the relationship to angle and anterior segment parameters as measured by anterior segment optical coherence tomography (AS-OCT). In 81 eyes (69 patients), the mean preop IOP was 15.02 mm Hg on 1.89 glaucoma medications. The mean IOP reduction was 2.1 mm Hg (12.8%). There was a greater IOP reduction in eyes with narrow angles compared with eyes with open angles. Preop IOP, angle-opening distance, and lens vault were predictors for IOP reduction, the researchers concluded. The study is published 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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