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FDA Authorizes Clinical Trial for CRISPR/Cas9 Therapy for LCA 10

Editas Medicine , a company developing gene-editing treatments, has received authorization from the US Food and Drug Administration to launch a clinical trial for its emerging CRISPR/Cas9 therapy for people with a mutation in the gene CEP290, which causes Leber congenital amaurosis 10 (LCA10). LCA causes severe vision loss or blindness at birth. Known as EDIT-101, the treatment will be evaluated in a Phase 1/2, dose-escalation clinical trial.  The company expects to enroll 10 to 20 patients. Further details and contact information for the study will be listed soon at www.clinicaltrials.gov . EDIT-101 targets a specific mutation, “c.2991+1655A>G” in intron 26, of the CEP290 gene. Editas has earned a $25 million milestone payment from Allergan as part of a drug-development alliance. “We are very pleased with this historic milestone in the treatment of inherited retinal diseases,” says Stephen Rose, PhD, chief scientific officer, Foundation Fighting Blindness. “EDIT-101 is the fi...
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Novartis launches app for remote participation in clinical trials

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APR 26, 2018 By Anni Griswold Novartis Comprehensive Ophthalmology A new smartphone app lets patients participate in ophthalmology trials without ever stepping foot in a clinic. Novartis’ FocalView app guides patients through self-assessments of visual function and disease activity, streaming large volumes of real-world data directly into researchers’ hands. The app, created using Apple’s ResearchKit platform, aims to dissolve barriers to patient participation by easing the enrollment process, improving compliance and reducing the time and expense of clinical exams. Data capture in traditional ophthalmic clinical trials tends to be “inflexible and infrequent,” Novartis says, so adapting a trial’s design to fit the daily routine of patients could spur participation. If proven effective, FocalView could help uncover key insights about disease manifestation or progression by providing researchers with real-time reports collected over a span of months or years. “Optimizing di...
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Week in review: Insta-fail, shoebox-sized scanner, President Samuelson

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APR 20, 2018 By Anni Griswold Cornea/External Disease, Glaucoma, Retina/Vitreous A weekly roundup of ophthalmic news from around the web. An Instagram model paid the ultimate price to change her eye color from hazel to light grey. Nadinne Bruna, 32, shelled out $3,000 to have silicone plates implanted in front of her iris, but the procedure ended up costing her much more: 80% of vision in her right eye and 50% in her left eye. Daily Mail Glaucoma expert Thomas W. Samuelson, MD, took the reins this month as the 33 rd president of the American Society of Cataract and Refractive Surgery (ASCRS). Samuelson is an attending surgeon and founding partner of Minnesota Eye Consultants, and an adjunct professor of ophthalmology at the University of Minnesota. Healio Canadian engineer Marinko Sarunic says his shoebox-sized retinal scanner (shown above) can capture high-resolution, 3-D, cross-sectional images of the tissue in a level of detail that rivals images from much larger s...
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