EW Weekly, November 28, 2016

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November 28, 2016
Volume 21 , Number 44

FDA clears XEN gel stent for refractory glaucoma

The Food and Drug Administration (FDA) granted regulatory approval to the XEN Glaucoma Treatment System (consisting of the Xen45 Gel Stent and the Xen Injector) for the management of refractory glaucomas, where previous surgical treatment has failed or in patients with primary open angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy. Marketer Allergan (Dublin, Ireland) said the Xen is implanted through an ab interno approach and reduces IOP by creating a new drainage channel with a permanent implant that becomes flexible. In the U.S. pivotal trial, the device reduced IOP from a mean medicated baseline of 25.1 (±3.7) mm Hg to 15.9 (±5.2) mm Hg at the 12-month visit (n=52). The mean baseline number of IOP-lowering medications was 3.5 (±1.0) versus an average use of 1.7 (±1.5) medications at 12 months. Allergan plans to launch the XEN Glaucoma Treatment System in the U.S. in early 2017.

First swept-source OCT imaging device cleared in U.S.

The FDA approved the Zeiss Plex Elite 9000 swept-source optical coherence tomography (OCT) for posterior ocular structures, Carl Zeiss Meditec (Jena, Germany) said in a news release. The wide-field high-resolution visualization provided by the swept-source OCT and OCT angiography imaging of the Plex Elite platform "expands clinicians' ability to examine the critical microstructures and microvasculature of the posterior segment at any depth of interest from vitreous to sclera," the company said. The swept-source OCT and OCT angiography platform was designed for advanced retina research and is at the core of the Advanced Retina Imaging (ARI) Network. The ARI Network, led by Philip Rosenfeld, MD, is focused on exploring new clinical applications for the diagnosis and treatment of eye disease and advancing OCT innovation to benefit patients today and in the future.

EyeGate's Ocular Bandage Gel on de novo path

Following a pre-submission meeting with U.S. regulators, EyeGate Pharma (Waltham, Massachusetts) confirmed it will pursue U.S. regulatory clearance of its EyeGate Ocular Bandage Gel (OBG), via the de novo 510(k) pathway. The OBG represents the first product candidate from the company's crosslinked, thiolated carboxymethyl hyaluronic acid (CMHA-S) platform. The OBG is a synthetic biocompatible CMHA-S hydrogel "capable of coating the ocular surface and designed to resist degradation under conditions present in the eye. This prolongs residence time of the bandage on the ocular surface, addressing the limitations of current non-crosslinked hyaluronic acid formulations," the company said. EyeGate Pharma expects to release topline results by year end from an initial pilot study evaluating the ability of the OBG to accelerate ocular surface re-epithelialization following PRK.

RESEARCH BRIEFS

  • A single subconjunctival injection of XG-102 (brimapitide, Xigen, Epalinges, Switzerland) at the end of ocular surgery is non-inferior to dexamethasone eye drops in the treatment of postoperative ocular inflammation, according to C. Chiquet and colleagues. In their multicenter, randomized, parallel group, double-masked study, patients were administered a single subconjunctival injection of 250 μl XG-102 90 μg (N=47), 900 μg (N=48), or placebo (N=50) at the end of ocular surgery. Subconjunctival injection for each group, XG-102 90 μg, XG-102 900 μg, or placebo, was followed by eye drops instilled four times/day for 21 days with placebo, placebo or dexamethasone solutions, respectively. The anterior cells grade for the XG-102 groups was non-inferior to dexamethasone (-0.054 anterior cell grade, p for non-inferiority <0.001) for XG-102 900 μg and -0.086 anterior cell grade, p for non-inferiority=0.003 for XG-102 90 μg. Rescue medication was introduced for 10 (21%), seven (15%), and two (4%) patients allocated to XG-102 90 μg, XG-102 900 μg, and dexamethasone, respectively. The difference between XG-102 90 μg and dexamethasone was statistically significant (p=0.013). The study is published in the American Journal of Ophthalmology.
  • A new study has added to the limited published data on a protective effect of adherence to a Mediterranean dietary pattern in those with late age-related macular degeneration (AMD), although it does not support previous reports of a relationship with genetic susceptibility. R.E. Hogg and colleagues randomly sampled people aged 65 years or older from seven study centers across Europe (Estonia, France, Greece, Italy, Norway, Spain, and the U.K.) and obtained full dietary data from 4,753. The mean age of participants was 73.2 years, and 55% were women. A previously published Mediterranean Diet Score (MDS) was used to classify participants according to their responses on the food frequency questionnaire (FFQ). Increasing MDS was associated with reduced odds of neovascular AMD in unadjusted and confounder-adjusted analysis. Compared with the lowest MDS adherence (≤4 score), those in the highest category MDS adherence (>6 score) showed lower odds of neovascular AMD (odds ratio, 0.53; 0.27-1.04; P trend=0.01). The association with MDS did not differ by Y204H risk allele (P=0.89). For all early AMD (grade 1-3), there was no relationship with MDS. There was a weak trend between MDS and large drusen; those in the highest category of MDS had 20% reduced odds compared with those in the lowest (P=0.05). The study is published in Ophthalmology.
  • Older age and higher preoperative astigmatism, sphere, and corneal steepness were associated with a higher rate of myopic LASIK retreatment, according to Russell Pokroy, MD. He and colleagues retrospectively analyzed 9,177 right eyes in 9,177 consecutive myopic LASIK performed between January 2005 and December 2012 according to whether they had retreatment refractive surgery. The mean preoperative subjective spherical equivalent and astigmatism were −3.30±1.53 D and 0.69±0.94 D, respectively. Of the eyes, 165 (1.80%) had at least one retreatment. Over the course of the study, the 2-year retreatment rate decreased from 2.58% to 0.38% (P<.001). Multiple binary logistic regression analysis showed that older age (P=.007), higher astigmatism (P=.008), sphere (P=.026), and mean keratometric power (P=.036) significantly increased the odds for retreatment. A larger optical zone ablation (7.0 mm) significantly decreased the odds for retreatment (P=.022). The study is published in the Journal of Cataract & Refractive Surgery.

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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