EW Weekly, July 1, 2016

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July 1, 2016
Volume 21 , Number 23

FDA approves Raindrop Near Vision Inlay

The Food and Drug Administration approved the Raindrop Near Vision Inlay (ReVision Optics, Lake Forest, California) for the treatment of presbyopia. The Raindrop is indicated to improve near vision by reshaping the anterior curvature of the cornea in presbyopic patients who have emmetropic refractions (+1.00 D to -0.50 D). Approval was based on the results of 373 patients treated at 11 investigational sites in the U.S., ReVision Optics said. Studies show the Raindrop improved average uncorrected near visual acuity (UCNVA) by 5 lines on a standard eye chart without any loss of binocular distance vision. Plus, 98% of patients achieved UCNVA of 20/40 or better and 88% of patients achieved UCNVA of 20/25 or better at 24 months in the treated eye. The mean uncorrected visual acuity for both eyes exceeded 20/20 at all distances-near, intermediate, and distance. ReVision Optics plans to launch the inlay sometime in the third quarter. The FDA added the Raindrop is not recommended for patients who: have severe dry eye or an active eye infection or inflammation; exhibit signs of keratoconus; have abnormal features of the cornea to be implanted; have certain autoimmune or connective tissue diseases; do not have enough corneal thickness to withstand the procedure; have a recent herpes eye infection or problems resulting from a previous infection; or have uncontrolled glaucoma or uncontrolled diabetes.

Nevanac granted new indication in Europe

The Committee for Medicinal Products for Human Use adopted a positive opinion recommending a new indication for the 3 mg/ml strength Nevanac (nepafenac, Alcon, Fort Worth, Texas), the agency said. The new indication now includes "reduction in the risk of postoperative macular edema associated with cataract surgery in diabetic patients," in addition to the already-approved indications of prevention/treatment of postoperative pain and inflammation associated with cataract surgery.

Early study results for LHONtreatment show promise

A phase 1/2 study on an intravitreal injection of GS010 for the treatment of Leber's hereditary optic neuropathy (LHON) has shown promising results, developer GenSight Biologics (Paris) said in a news release. Each cohort of 3 patients was administered an escalating dose of GS010, which leverages a mitochondrial targeting sequence proprietary technology platform that, when associated with the gene of interest (in this case ND4), allows the platform to specifically address defects inside the mitochondria using an adeno-associated virus vector. At 48 weeks post-injection, patients with an onset of disease of less than 2 years gained 30 letters in the treated eye and 13 letters in the untreated eye; no significant difference was observed in patients with an onset of disease of more than 2 years. GS010 is in phase 3 studies in the U.S. and Europe. Top line results from these studies are expected in late 2017.

NAION study begins next phase in India

The first patient in India has been randomized in a pivotal global phase 2/3 study of QPI-1007, a novel small interfering RNA (siRNA) drug for the treatment of acute non-arteritic ischemic optic neuropathy (NAION), developers Biocon (Bangalore, India) and Quark Pharmaceuticals (Fremont, California) said in a press release. QPI-1007 is a double stranded RNA molecule chemically modified by Quark's proprietary technology. The drug is designed to temporarily inhibit the expression of caspase 2 and thereby block the apoptotic death of retinal ganglion cells. QPI-1007 is being developed as a neuroprotectant for the treatment of NAION and in the future other optic neuropathies such as glaucoma that result in the death of retinal ganglion cells. QRK207 is a pivotal, randomized, double-masked, sham-controlled trial of QPI-1007 delivered by multi-dose intravitreal injections to subjects with acute NAION to compare the safety and efficacy of 2 doses of QPI-1007 along with the sham group. The multinational, multi-centric trial is being conducted across 95 centers in Australia, Germany, India, Israel, Italy, and the U.S. Approximately 465 patients will be enrolled globally.

Pain medication may preserve vision

Researchers at the Medical College of Georgia at Augusta University have shown (+)-pentazocine enables the survival of cone cells in animal models of severe, inherited retinal degeneration, the university said in a news release. By day 42, when vision should have been lost, several layers of photoreceptor cells were still clearly visible in the treated mice, and the vast majority of those cells were cones. Mice lacking sigma receptor 1 did not benefit from (+)- pentazocine treatment, more evidence of the receptor's essential role in retinal protection, according to Sylvia Smith, PhD, chair of the Department of Cellular Biology and Anatomy. Treated mice also had evidence of reduced oxidative stress.

RESEARCH BRIEFS

  • Tilted, large, or small discs were prevalent in eyes with primary open-angle glaucoma (POAG) and high myopia, according to a group of Taiwanese researchers. L.W. Chen and colleagues reviewed data from 375 Taiwanese patients (375 eyes) with POAG, ages 20 to 60 years. Optic disc photographs were used for planimetric measurements of morphologic variables. The myopic refraction was divided into high myopia (<-6.0 D) and non-high myopia (moderate myopia to hyperopia). Of the 142 highly myopic eyes, 33 (23%) had a large disc, 26 (18%) had a small disc, and 55 (39%) had a tilted disc. Large discs had a higher cup-to-disc (C/D) area ratio and a higher tilt ratio; small discs had a smaller rim area and a lower tilt ratio (all P<0.05). Characteristics associated with high myopia included a smaller rim area, a higher C/D area ratio, and a lower tilt ratio (all P<0.001). In logistic regression, the refraction, the C/D area ratio, the rim area, and the tilt ratio (all P<0.05) were associated with VF defects. The study is published in the Journal of Glaucoma.
  • A new image-guided system had high repeatability for keratometry (K), steep axis, and white-to-white (WTW) measurements, according to A. Mueller and colleagues. In their prospective case series, 123 eyes of 123 volunteers (mean age 37.9±16.2 years) were examined with partial coherence interferometry (PCI), optical low-coherence reflectometry (OLCR), a Scheimpflug device, and a new image-guided system by the same examiner. The image-guided system measured statistically significant smaller flat, steep, and average corneal radii than the Scheimpflug device, statistically significant larger flat and average corneal radii than the PCI device, and no statistically significant different values than the OLCR device. The measured steep axis did not differ significantly in any comparison. The WTW measurements were significantly higher than those of all other devices. The analysis of repeatability of the image-guided system showed high intraclass correlation coefficients (range 0.919 to 0.997). The study is published in the Journal of Cataract & Refractive Surgery.
  • Intense pulsed light (IPL) therapy for evaporative dry eye disease (DED) is a safe and effective procedure, according to Preeya Gupta, MD, and colleagues. In their multicenter cohort study, patients diagnosed with meibomian gland dysfunction (MGD) and dry eye underwent IPL therapy from September 2012 through December 2014. On average, patients underwent 4 IPL sessions. There was a significant decrease in scoring of lid margin, facial telangiectasia, lid margin vascularity, meibum viscosity, and OSDI score, all p<0.001. There was a significant increase in oil flow score and tear break-up time, both p<0.001. No significant changes in intraocular pressure or acuity were noted. There were no cases of adverse ocular effects. The study is published in the Canadian Journal of Ophthalmology. 

NEW PRODUCT BRIEFS

  • Bio-Tissue (Doral, Florida) introduced Cliradex Light, a preservative-free, all-natural lid, lash, and facial cleanser. Cliradex Light is a mild foam formulation with a lower concentration of 4-Terpineol than Cliradex, and is used to alleviate symptoms of mild to moderate blepharitis, dry eye, ocular rosacea, meibomian gland disease, and other lid margin diseases. It can also be used as a follow-up treatment in the regular maintenance of Demodex blepharitis.

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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