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USA
CHINA INDIA ASIA PACIFIC KOREA RUSSIA
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September 26, 2014
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Volume 19, Number 33
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Americans value sight over other senses
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According to a new poll, Americans across racial and ethnic groups describe losing eyesight as potentially having the greatest impact on their day-to-day life-more so than other conditions, including loss of memory, hearing, and speech, the Association for Research in Vision and Ophthalmology (ARVO, Rockville, Md.) said in a press release.
A higher percentage of African-Americans (57%) cite this concern compared to non-Hispanic whites (49%), Asians (43%), and Hispanics (38%), ARVO added.
Blindness ranked among the top four "worst things that could happen" for all respondents, alongside cancer, Alzheimer's disease, and HIV/AIDS. More African Americans cited blindness as their top fear.
A large majority of respondents strongly consider research to improve the prevention and treatment of vision disorders a priority (83% of African Americans and non-Hispanic whites, 80% of Asians and 79% of Hispanics).
When told that the federal government spends on average $2.10 per person each year on such research, half of African Americans (51%) and Hispanics (50%) say this is not enough followed by non-Hispanic whites (47%) and Asian-Americans (35%).
These and other findings are from a national public opinion poll commissioned by Research!America and the Alliance for Eye and Vision Research (AEVR). The poll was funded by a grant from Research to Prevent Blindness.
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B+L, Nicox release top-line results
from phase 3 IOP study
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Top-line results from two pivotal phase 3 studies on Vesneo (latanoprostene bunod; previously known as BOL-303259-X and NCX 116) for the reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension indicate the formulation met its primary end points, developers Bausch + Lomb (B+L, Bridgewater, N.J.) and Nicox (Sophia Antipolis, France) said in a joint press release. Vesneo showed a reduction in mean IOP of 7.5 to 9.1 mmHg from baseline between 2 and 12 weeks of treatment in the two studies.
The pivotal phase 3 program includes two separate randomized, multicenter, double-masked, parallel group clinical studies, APOLLO and LUNAR, designed to compare the efficacy and safety of Vesneo administered once daily against timolol maleate 0.5% administered twice daily in lowering IOP in patients with open-angle glaucoma or ocular hypertension. The primary endpoint of both studies, which include a combined total of 840 patients, was the reduction in mean IOP measured at specified time points during 3 months of treatment. Patient safety data will continue through the initial 12 months of treatment and is ongoing. B+L expects to file for U.S. regulatory approval during the first half of 2015.
Vesneo is a novel nitric oxide-donating prostaglandin F2-alpha analog licensed by Nicox to B+L.
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FDA clears phase 2 study of
eye drops for dry eye
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The Food and Drug Administration has cleared the Investigational New Drug application (IND) for a phase 2 clinical study of Cis-urocanic acid (Cis-UCA) Eye Drops for the treatment of dry eye syndrome, developer Herantis Pharma (Helsinki, Finland) said in a press release. Patient enrollment in the clinical study is planned to start by the end of 2014.
According to the company, the study will be conducted at three investigational sites in the U.S. and will enroll a total of 150 patients randomized in three treatment groups receiving either placebo or one of two different doses of Cis-UCA Eye Drops. The active ingredient in Cis-UCA is an endogenous small molecule component of human and animal skin. It is constantly present in the human body and has been identified as a locally acting anti-inflammatory agent that also reduces free radicals.
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Novaliq reports positive phase
1 dry eye results
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Positive phase 1 results with the first and only clear cyclosporin solution eye drop formulation in clinical development for patients with dry eye syndrome (CyclASol, Novaliq, Heidelberg, Germany) have been released.
Objectives of the 18 patient phase 1, double-blind, randomized, placebo-controlled crossover study were to investigate safety, local tolerability, and systemic exposure of CyclASol eye drops and vehicle following single and multiple ocular doses in healthy volunteers. No drug-related signs or symptoms of ocular discomfort or irritation were reported, including dryness, grittiness, burning, stinging, tiredness, blurred or foggy vision, redness, watery eyes, eye mucus, or crusting. In slit lamp examinations, no subjects revealed any clinically abnormal signs of the anterior and posterior eye structures. With dosing of up to 4 drops per eye per day, no systemic levels of cyclosporin were detected after any dose or at any time point when using a highly sensitive assay with an LLOQ as low as 0.1 ng/ml.
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RESEARCH BRIEFS
- The Global Burden of Disease (GBD) Study 2010 compiled data from 1990 to 2010 on 291 diseases and injuries, 1,160 disease and injury sequelae, and 67 risk factors in 187 countries. Lindsay N. Boyers and colleagues assessed 8 ophthalmologic conditions in the Cochrane Database of Systematic Reviews (CDSR) for systematic review and protocol representation according to subject content. The diseases were matched to their respective disability-adjusted life years (DALYs) from the GBD 2010 project. All 8 ophthalmologic conditions were represented by at least 1 systematic review in the CDSR. A total of 91.4% of systematic reviews and protocols focused on these conditions were from the Cochrane Eyes and Vision Group. Comparing the number of reviews and protocols with disability, only cataract was well matched; glaucoma, macular degeneration, and other vision loss were overrepresented. In comparison, trachoma, onchocerciasis, vitamin A deficiency, and refraction and accommodation disorders were underrepresented. The study is published online ahead of print in JAMA Ophthalmology.
- According to the Infant Aphakia Treatment Study Group, the increased rate of complications, adverse events, and additional intraocular surgeries associated with IOL implantation in infants <7 months of age militates toward leaving babies aphakic if it is considered likely that the family will be successful with contact lens correction. David A. Plager and colleagues reported in American Journal of Ophthalmology that there were more patients with intraoperative complications (28% vs. 11%, P=.031), adverse events (81% vs. 56%, P=.008), and more additional intraocular surgeries (72% vs. 16%, P<.0001) in the IOL group than in the contact lens group. However, the number of patients with adverse events in the contact lens group increased (15 to 24) in postoperative years 2-5 compared to the first postoperative year, while it decreased (44 to 14) in years 2-5 compared to the first postoperative year in the IOL group.
- There were no significant differences in the tear meniscus parameters between the microkeratome and femtosecond laser groups. The depth of ablation was significantly correlated with the lower tear meniscus parameters of area (LTMA) only at 1 week after surgery. W. Xie and colleagues analyzed 60 eyes of 30 myopes; 15 underwent LASIK with Moria II microkeratome and the other 15 patients with the 60-KHz IntraLase femtosecond laser. Compared to the baseline values, all tear meniscus parameters decreased significantly at each postoperative time point (all P<0.01) in both groups. Lower tear meniscus parameters of height increased significantly between 1 week and 1 month and between 1 and 3 months after surgery in the microkeratome (both P<0.01) and femtosecond laser groups (P<0.01, P=0.012, respectively). There were significant increases in LTMA between 1 week and 1 month after surgery in the microkeratome group (P<0.01) and in the femtosecond laser group (P=0.028). The study is published in Investigative Ophthalmology & Visual Science.
NEW PRODUCT BRIEFS
- Optovue (Fremont, Calif.) has launched the iScan in the U.S., the company said. With Optovue's proprietary iWellness scan, iScan guides the patient through the entire exam and requires minimal operator involvement. The iWellness scan provides a cross-sectional view of the retinal layers, a retinal thickness map, and a ganglion cell complex map, Optovue said.
- Leica Microsystems (Wetzlar, Germany) and TrueVision 3D Surgical have globally launched the Leica M844 and Leica M822 ophthalmology microscopes with TrueVision 3D visualization, recording, and editing technology, the companies announced.
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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: David F. Chang, MD, chief medical editor; Bonnie An Henderson, MD, cataract editor; Clara C. Chan, MD, cornea editor; Reay H. Brown, MD, glaucoma editor; Eric D. Donnenfeld, MD, refractive editor; and John A. Vukich, MD, international editor For sponsorship opportunities or membership information, contact: ASCRS*ASOA * 4000 Legato Rd. * Suite 700 * Fairfax, VA 22033 * Phone: 703-591-2220 * Fax: 703-591-0614 * Email: ASCRS Opinions expressed in EyeWorld Week do not necessarily reflect those of ASCRS*ASOA. Mention of products or services does not constitute an endorsement by ASCRS*ASOA.
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Copyright 2014, EyeWorld News Service, a division of ASCRS Media. All rights reserved.
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