Happy New Year! Dan Roberts. International Low Vision Support Group NEWSLETTER. This Month. In This Issue
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1 In This Issue 1: This Month 2-4: News 5: A Message to Your Doctor Happy New Year! from Macular Degeneration Support The ILVSG is sponsored by MD Foundation ILVSG TeleSupport is sponsored by MD Support and Genentech, Inc. International Low Vision Support Group NEWSLETTER Volume 13, Issue 1 - Jaunary This Month Your Amazing Eyes Our January presentation offers some light fare to help us launch into our 2018 series of monthly topics. In it, I will talk about: How your eye is built Fascinating facts about your eyes Interesting trivia about your eyes How a baseball player sees a fastball (a theoretically impossible feat) We often hear about the wonderful ways our brains work for us, but our eyes sometimes don't get the credit and respect they deserve. Still (ironically), we don't really need our eyes to see, since we actually see with our brains. So even though we may be losing some vision capability, we are still able to perform nearly all normal daily living activities without them. As miraculous as our eyes are, isn t it interesting (and encouraging) to know that, with diligence and willingness to adapt, we can still be okay? I hope you will carry this thought with you through the coming year, and that you will live every day like it s your first--with all of the hope and excitement 2018 promises to bring! 1 Dan Roberts
2 FDA Approves First Gene Therapy for Inherited Retinal Dystrophy The U.S. Food and Drug Administration (FDA) has approved Luxturna (voretigene neparvovec-rzyl), a new gene therapy developed by Spark Therapeutics, to treat an inherited form of vision loss that can result in blindness. The most prevalent inherited retinal dystrophies are retinitis pigmentosa (RP), Leber congenital amaurosis (LCA) and Stargardt disease (SD), all of which have in common a mutation of the RPE65 gene. Patients with Leber congenital amaurosis will be the first beneficiaries of retinal gene therapy, with RP and SD to follow after further study. Ocular injection of Luxturna introduces a benign virus to deliver healthy copies of the gene to the retina. In the recently-completed Spark study at the University of Iowa and Children s Hospital of Philadelphia, patients receiving Luxturna showed significant vision improvement. This success resulted in Priority Review and Breakthrough Therapy designations from the FDA, which helps speed promising treatments through trials. Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene. It is approved for treatment of patients with confirmed mutation of both copies of the RPE65 gene. The therapy is expected to be available in selected centers by Spring of I believe gene therapy will become a mainstay in treating, and maybe curing, many of our most devastating and intractable illnesses, said FDA Commissioner Scott Gottlieb, M.D. 2
3 Apellis Entering Phase 3 Trials for Dry Macular Degeneration ILVSG Newsletter Apellis Pharmaceuticals has announced that it has finalized the trial design for its planned Phase 3 program evaluating APL-2 for the treatment of patients with geographic atrophy (GA), aka dry macular degeneration. The Phase 3 program, planned to begin in the second half of 2018, will consist of two identical studies to assess the efficacy and safety of multiple injections of APL-2 in the eyes of patients with GA. The Phase 3 trials will be substantially similar in design to Apellis ongoing Phase 2 FILLY trial, which, at 12 months, showed a 29% reduction in the growth of GA lesions (damaged areas of the retina) in the monthly treatment group and a 20% reduction in the every other month treatment group. Our Phase 3 trial design is intended to address a patient population similar to the one we studied in Phase 2, which we believe is representative of the general population of patients with GA in the United States, said Cedric Francois, MD, PhD, founder and chief executive officer of Apellis. Currently there are no approved treatments for the approximately one million patients suffering from GA in the US. We believe that by slowing down the rate of degeneration of retinal tissue through broad C3 inhibition, we may be able to delay or prevent the progression to blindness in these patients. Iluvian Continues to Show Good Results in DME Trials We reported here in 2015 that Iluvian, a unique drug implant devised by Alimera Sciences, had entered trials for treatment of diabetic macular edema (DME). The drug is a corticosteroid that has demonstrated effectiveness in the treatment of DME without the need for monthly injections. 3
4 Jay Prensky, MD (investigator for Alimera Sciences) reported to the November 2017 meeting of the American Society of Retina Specialists that Iluvian has provided study subjects with anatomic and visual improvements at the 6-month evaluation in a phase IV study of the implant s efficacy, anatomic, and safety outcomes. Patients with the worst baseline vision had the greatest improvements compared with those with better initial vision, with best corrected visual acuity improving significantly beginning as early as 7 days after the implant and sustaining out to the 6-month time point. Additionally, concurrent decreases in the central subfield thickness were seen early after implantation and remained decreased to the 6-month evaluation. Alimera Sciences also began studying Iluvian as a potential treatment for dry macular degeneration, but concerns by the FDA about safety and manufacturing standards have slowed its progress toward clinical trials. -- NEXT MONTH -- "Acting Blind" Guest hosts Nancy and Peter Torpey talk with professional actor George Ashiotis about his career and experiences as a blind performer and how he has managed to live his dream in spite of the barriers. Please help your ophthalmologist help you and others by taking the following page to your next visit. 4
5 Free elearning Program For Ophthalmologists From Lighthouse Guild Vision rehabilitation is the standard of care for patients who are losing their vision, and ophthalmologists are key to improving access to care for these patients. Recognizing this, Lighthouse Guild is offering ophthalmologists free access to an elearning program titled, Introduction to Vision Rehabilitation. Dr. Alan R. Morse, President and CEO of Lighthouse Guild, says, It is important that all ophthalmologists understand how vision rehabilitation can help their patients. Providing patients with information about vision rehabilitation options and initiating referral to services as early as possible in the treatment process is crucial to improving their quality of life. The program is designed to provide ophthalmologists with an introduction to vision rehabilitation and basic strategies to help their patients. It is self-paced, divided into ten modules, and can be completed in approximately two hours. The ten modules review terminology, the impact of vision loss, and highlight the importance of vision rehabilitation services. The program also discusses optical principles and selection and use of low vision devices. The program is accessible on the One Network of the American Academy of Ophthalmology (AAO) website. 5
Dan Roberts. International Low Vision Support Group NEWSLETTER. This Month. In This Issue. 1: This Month 2-5: News
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