EyeWorld Weekly Update, February 17, 2017

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February 17, 2017
Volume 22 , Number 7

First patient enrolled in Phase 3 clinical trial of Zuprata with Eylea for RVO

The first patient has been enrolled in a multicenter, randomized, masked controlled Phase 3 clinical trial of Zuprata (triamcinolone acetonide, Clearside Biomedical, Alpharetta, Georgia), used with Eylea (aflibercept, Regeneron Pharmaceuticals, Tarrytown, New York) to treat macular edema associated with retina vein occlusion (RVO). The trial, called SAPPHIRE, was established to test the efficacy and safety of suprachoroidally administered Zuprata along with intravitreally administered Eylea in subjects with RVO. In the combination treatment arm, subjects will receive both treatments at the start of the trial and then just intravitreal Eylea at week 4. At weeks 12 and 24, subjects will again receive both treatments. In the control arm, patients will receive only Eylea at the start of the trial and follow-up treatments with Eylea every 4 weeks through week 24. The trial's main objective is to assess the proportion of patients in each arm with an improvement of at least 15 letters in best corrected visual acuity compared with baseline at 8 weeks after the first treatment. Clearside Biomedical expects a total enrollment of about 460 patients in the trial. "Based on the visual acuity improvements and macular edema reductions observed in its previous phase 2 TANZANITE trial, we believe the SAPPHIRE study has the potential to demonstrate that the addition of Zuprata to Eylea treatment may offer an earlier opportunity for improved vision and reduction of macular edema over Eylea treatment alone," said Daniel H. White, Clearside's CEO and president, in a press release.

IND active for Phase 1 trial of RGX-314 to treat wet AMD

An Investigational New Drug (IND) application is active for a multicenter, open-label, multiple-cohort, dose-escalation Phase 1 trial of RGX-314 (REGENXBIO, Rockville, Maryland) to treat wet age-related macular degeneration (AMD). The trial for RGX-314 will include about 18 previously treated wet AMD patients who are responsive to anti-vascular endothelial growth factor therapy and who are at least age 50. Primary trial endpoints include adverse events, laboratory measures (including immunological parameters), and results from ocular examinations and imaging. The study's primary purpose is to assess safety and tolerability of RGX-314 at 24 weeks after one RXG-314 dose by subretinal delivery; after this, subjects are expected to enter a follow-up period lasting for 106 weeks to help assess long-term safety and durability of effect. REGENXBIO reports that RGX-314 is a one-time, subretinal treatment for wet AMD and includes a NAV AAV8 vector encoding a gene for monoclonal antibody fragment. The expressed protein is designed to neutralize vascular endothelial growth factor activity, which modifies the pathway for the formation of new leaky blood vessels and retina fluid accumulation, according to a company press release. "In animal studies, treatment with RGX-314 gene therapy led to rapid and sustained anti-VEGF protein detected in the eyes of treated animals. Preclinical studies have shown anti-VEGF mRNA and protein distributed widely through the retina," said Albert Maguire, MD, University of Pennsylvania Gene Therapy Program and Center for Advanced Retinal and Ocular Therapeutics, Philadelphia, in a company press release.

SightLife Surgical names advisory board

SightLife Surgical (Seattle) has named its medical advisory board. Edward Holland, MD, Cincinnati, will chair the board. Also included on the board are John Berdahl, MD, Sioux Falls, South Dakota, Nicole Fram, MD, Los Angeles, Terry Kim, MD, Durham, North Carolina, Elizabeth Yeu, MD, Norfolk, Virginia, and Richard Lindstrom, MD, Minneapolis. The board will play a role in challenging the status quo of the cornea ecosystem and help push for advancements in the treatment of corneal blindness. The board is separate from the medical directors at SightLife Surgical, who determine if donated tissue is suitable for transplant. SightLife Surgical is a for-profit arm of SightLife, a nonprofit global health organization that aims to eliminate cornea blindness around the world by the year 2040.

RESEARCH BRIEFS

  • Excimer laser surgery is safe in patients with well-controlled collagen vascular or other immune-mediated disease, according to the results of a retrospective case series. Researchers, led by Julie M. Schallhorn, MD, assessed visual and refractive outcomes and complications after surgery in 622 patients (1,224 eyes) with rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, sarcoidosis, ankylosing spondylitis, multiple sclerosis, and scleroderma. Most of the eyes had LASIK surgery, and a small portion had PRK. There was a mean follow up of 10.9 months. After surgery, 81.8% of LASIK eyes and 82.3% of PRK eyes were within ±0.50 D, and the uncorrected distance visual acuity was 20/20 or better in 76.8% and 73.4%, respectively. With the exception of one peripheral flap melt, any complications that occurred were within the norm that would be expected after excimer laser surgery. The research is published in the Journal of Cataract & Refractive Surgery.
  • A meta-analysis of nonsteroidal anti-inflammatory drugs found they were effective compared with placebo for the relief of anterior chamber inflammation after cataract surgery. In the study, which reviewed 19 trials and 7,234 patients, diclofenac was linked with the greatest improvements in anterior chamber inflammation after surgery. This was followed by nepafenac, ketorolac, bromfenac, and flurbiprofen. Nepafenac had the greatest association with postoperative ocular pain release. Although piroxicam had the fewest related adverse events, researchers said that the robustness of that finding was low. The meta-analysis is published in Graefes Archives for Clinical and Experimental Ophthalmology, and the research was led by Ping Duan.
  • The inferior hemifield had the greatest association with motor vehicle collisions with oncoming cars in patients with advanced glaucoma compared with other specific visual subfields, according to Shiho Kunimatsu-Sanuki, MD, and co-researchers. They analyzed the role of visual subfields in crashes with oncoming cars during simulated driving. The study had 43 normal subjects and 100 with advanced glaucoma, but five of the glaucoma subjects experienced simulator sickness, so this decreased the number of glaucoma patients to 95. Patients with advanced glaucoma were older and had worse visual acuity in their better eye; they also had a lower mean integrated visual field sensitivity in the inferior hemifield compared with those who were not involved in collisions. The study is published in the British Journal of Ophthalmology.
  • Although anti-VEGF therapy is generally safe in patients with pterygium, the current evidence does not strongly support its use in pterygium surgery, according to research published by Jennifer Wei Huen Shum, FCOphthaHK, and co-researchers. It also not yet known what the optimal route and dosage of anti-VEGF therapy is for this patient group. The researchers analyzed the literature to gain a better understanding of the safety and efficacy of the role of anti-VEGF treatments for pterygium excision. When surgery is not performed, anti-VEGF therapy on its own may have a positive effect on symptoms on vascularity, but it does not cause pterygium regression. However, there is some evidence that supports the use of anti-VEGF therapy as an adjuvant therapy when there is a higher dose and more frequent dosing. The research is published in Acta Ophthalmologica.

PRODUCT BRIEFS

  • eSight Corporation (Los Angeles and Toronto) launched eSight 3, which are electronic glasses that help the legally blind to experience up to 20/20 vision. The glasses have a proprietary camera that projects adjusted video on two OLED screens in front of the eyes in real time. eSight can be used while walking and while the user moves between different tasks and environments.

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; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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