EW Weekly, November 11, 2016

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November 11, 2016
Volume 21 , Number 41

First patients enrolled in ARISE-2 study

The first patients have been enrolled in a Phase 3 study evaluating thymosin beta-4 (Tβ4) for the treatment of dry eye syndrome, neurotrophic keratopathy (NK), and other corneal disorders, said developer RegeneRx (Rockville, Maryland) in a press release. The primary endpoints of the ARISE-2 study are the change in ocular discomfort and the change in inferior corneal staining at baseline (prior to first dose) and at the end of treatment (after last dose) with RGN-259 in a controlled adverse environment. RGN-259 is a sterile, preservative-free eye drop formulation being evaluated in about 500 patients in the ARISE-2 study. Tβ4 is a first-in-class, naturally occurring molecule that has been the subject of numerous published animal studies in the fields of ophthalmology, dermatology, cardiology, and central nervous system disorders, among others. In addition to the animal studies, the molecule has been tested in three unique formulations and routes of administration in approximately 650 patients and has an excellent safety profile. Study completion and patient data is expected during Q4 2017, the company added.

First British patient successfully implanted with the IRIS II

An epi-retinal implant with 150 electrodes intended for patients who have lost sight as a result of retinitis pigmentosa (RP) has been successfully implanted in a British patient at Moorfields Eye Hospital (London, U.K.), developer Pixium Vision (Paris, France) said. The IRIS II is undergoing evaluation as a treatment to compensate for blindness by the intended provision of a form of bionic vision and greater autonomy for patients in Austria, France, Germany, Spain, and the U.K. The implant activation and first light perception shows that "some visual perception may become available. It precedes the normal re-adaptation and re-education process where, per protocol, the patient enters a learning process to interpret the new form of bionic vision, which is different from the natural form of vision," the company said.

RESEARCH BRIEFS

  • Limbal conjunctival autograft (LCAG) transplantation with intraoperative 0.02% mitomycin-C (MMC) is as efficacious in treating recurrent pterygium as amniotic membrane graft (AMG) transplantation with MMC, R. Chen and colleagues found. They enrolled 96 eyes with recurrent pterygium and randomized them to pterygium removal followed by intraoperative 0.02% MMC for 3 minutes and then either LCAG or AMG transplantation. Follow-up was available for 93 eyes (82 patients) at 12 months. Grade D (recurrence) presented in one eye of the LCAG group and five eyes of the AMG group, with no between-group difference (p=0.196). However, Grades A, B, and C presented in 46, zero, and zero eyes of the LCAG group respectively, and in 37, two, and two eyes of the AMG group, respectively, with the surgical bed generally showing a better appearance in the LCAG group than in the AMG group (p=0.008). Compared with baseline values, the postoperative eye-movement amplitude improved significantly in both groups (p<0.001 for the LCAG group; p=0.001 for the AMG group), as did UDVA (p=0.005 for the LCAG group; p=0.012 for the AMG group). No between-group differences were found in terms of the healing time for epithelial defect, conjunctival inflammation grade, or the frequency of complications such as punctate epithelial keratitis, episcleral melting, corneal pannus, and delayed corneal epithelium healing. The study is published in Graefe's Archive for Clinical and Experimental Ophthalmology.
  • Femtosecond laser systems incorporating real-time 3-D spectral-domain optical coherence tomography (3-D SD-OCT) image analysis allowed direct visualization of Berger space intraoperatively, providing surgeons with the information needed to safely create posterior capsulotomies after intraocular lens implantation, according to Yesim Haeussler-Sinangin, MD, and colleagues. In their prospective, interventional case series, 155 eyes (of 165 enrolled eyes) were able to have Berger space and its dimensions analyzed by 3-D SD-OCT. In 72% of the cases, Berger space was large enough to perform a femtosecond laser-assisted primary posterior capsulotomy. In 24 eyes (15.5%) with a minimum axial length of 25.0 mm, Berger space was 500 μm or larger. The study is published in the Journal of Cataract & Refractive Surgery.
  • A retrospective claims analysis based on administrative claims from the HealthCore Integrated Research Database, a broad database representing claims from a large commercially insured population, has found several causes to adherence and nonadherence to diabetic eye examinations among insured patients. Maxine Fisher, PhD, and colleagues evaluated data from patients with diabetes who had ≥1 dilated eye examinations between August 1, 2011, and July 31, 2013, and who were defined as adherent to the Healthcare Effectiveness Data and Information Set (HEDIS) recommendations. Of 339,646 patients with diabetes identified in a claims data set, 43% were adherent and 57% were nonadherent to the HEDIS eye examination performance measure. The common barriers to routine eye examination cited by 29 patients across four focus groups included a lack of understanding of insurance benefits (n=15), a lack of awareness of the importance of dilated eye examinations (n=12), and time constraints (n=12). The common barriers cited by 18 providers included the patient's level of education (n=13), eye examinations as a lower priority than the management of other diabetes-related health issues (n=12), and a lack of symptoms (n=11). The study is published in American Health & Drug Benefits.

NEW PRODUCT BRIEFS

  • The World Health Organization (Geneva, Switzerland) and the Brien Holden Vision Institute jointly issued a new report on myopia and high myopia during the 10th General Assembly of the International Agency for the Prevention of Blindness. The Impact of Myopia and High Myopia report captures the evidence presented during the meeting on the magnitude of myopia, vision impairment and blindness in myopia, terminology and classification, pathological consequences, the impact on society, etiology, risk factors, and evidence for myopia control. It also identifies gaps in current knowledge, and makes recommendations to address the gaps with the aim to better inform clinical practice and public health policy.

EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (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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