Dan Roberts. International Low Vision Support Group NEWSLETTER. This Month. In This Issue. 1: This Month 2-5: News

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1 In This Issue 1: This Month 2-5: News Eye & Body Complete from Biosyntrx Extra Strength Protection Call for information The ILVSG is sponsored by MD Foundation ILVSG TeleSupport is sponsored by Biosyntrx, Inc. and Genentetech International Low Vision Support Group NEWSLETTER Volume 9, Issue 11 - November This Month We are happy to welcome back Ellen Troyer for her 10th annual presentation on different aspects of nutrition. Ellen is the goto person for advice and information about the importance of diet and nutrition for people with diseases of the eye. She is Chief Executive Officer and Chief Research Officer of Biosyntrx, a leading nutritional biotechnology company. She has edited or written chapters in a number of health books, co-authored peer-reviewed journal articles, and has published over 500 weekly articles on nutrition science and eye-disease. Ellen belongs to numerous organizations and sits on a number of professional boards related to nutrition and eye health, the most pertinent to us being our own Professional Advisory Board. She is also passionate about science, art, music, humanities, family, friends and age management; and that passion will be evident as we listen to her speak this month. Next month will be another opportunity to select favorite or missed programs (there are more than 100) from the ILVSG archives. If you have a request for a specific presentation or topic, let your group leader know. Dan Roberts 1

2 FDA Approves Two Extended-Release Drug Therapies For DME Implants devised by two different companies for treatment of diabetic macular edema (DME) have been approved by the FDA for use in the United States. The companies are Allergan and Alimera, and the new drugs are Ozurdex and Iluvien respectively. Both drugs are corticosteroids that have demonstrated effectiveness in the treatment of DME without the need for monthly injections. Tiny implants injected into the eye s vitreous gel release the steroids into the retina over a period of years, greatly relieving the burden of multiple clinic visits. Ozurdex is also indicated for treatment of macular edema following retinal vein occlusion, and for the treatment of noninfectious uveitis. Iluvian is also being studied as a treatment for dry macular degeneration (geographic atrophy), but concerns by the FDA about safety and manufacturing standards have slowed its progress toward clinical trials. Due to the high risk of cataract development and glaucoma, both extended-release steroid treatments are limited to adults without elevated intraocular pressure (IOP) and those who either have undergone, or are scheduled for, cataract surgery. Both therapies should be available in clinics by early Opportunity to Share Your AMD Experience If you or a loved one has Advanced Dry Macular Degeneration (AMD)/Geographic Atrophy (GA), we want to hear from you. Genentech, a leading biotechnology corporation, is looking for people who suffer from or who have a loved one who lives with AMD/GA to share their personal experiences in an upcoming focus group. Travel and lodging expenses will be covered by Genentech. Compensation will be provided for the participant s time as well. 2

3 To learn more, contact toll-free (855) , or reach out directly to the Patient Advocacy Lead, Angie Wilson, at or FDA Grants Priority Review for Lucentis in Diabetic Retinopathy Genentech has announced that the FDA has granted its submission for Priority Review of Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7 million Americans. The FDA confirmed action date is February 6, If approved, Lucentis could be the first eye medicine available for diabetic retinopathy patients. Lucentis was also the first FDA-approved medicine for diabetic macular edema (DME), a major cause of vision loss in people with diabetic retinopathy. The submission is based on results of the RISE and RIDE Phase III trials in which meaningful improvements in the disease were observed in a clinically significant proportion of diabetic retinopathy patients treated with Lucentis at two years compared to patients treated with sham injections (control group). Benefits of Lucentis treatment were maintained during year three of treatment. Stem Cell Trial Yields Surprising Results Advanced Cell Technology, Inc. has been conducting promising safety trials for stem cell treatment of macular degeneration, but a six-month follow up has yielded even better news than expected. Today ACT announced that Phase 1/2 clinical data published online in The Lancet demonstrated positive long-term safety results using stem cells for the treatment of Stargardt s macular degeneration (SMD) and dry age-related macular degeneration 3

4 (AMD). Surprising even the researchers, however, the results also showed that ten of the 18 patients could see significantly better, seven either got better or didn t lose any more vision, and only one got worse. Not only is the procedure proving to be safe, but vision improvement is already evident. According to the authors, these two studies provide the first evidence of the mid- to long-term effectiveness of pluripotent stem cell progeny into humans with any disease. In addition to showing vision improvement and safety, ACT s protocol also led to improved health (pigmentation) of the retinal pigment epithelium (RPE) in 13 of the 18 patients. The company plans to initiate comprehensive Phase 2 clinical trials soon for the treatment of both AMD and SMD. Study Shows No Difference Between Tinted and Clear IOLS For several years, eye doctors have been debating the value of tinted intraocular lenses (IOLs) in eyes that have undergone cataract surgery. Those in favor of them argue that they reduce the retina s exposure to potentially hazardous ultraviolet and blue light. The main argument against them is that they cause a decrease in dim light (scotopic) vision, which can be hazardous to the wearer. Now a recent study published in Optometry & Vision Science has demonstrated that there is no significant difference in visual acuity or macular changes between eyes implanted with UV- or blue-light filtering intraocular lenses. 30 patients with cataracts had a UV-light filtering IOL implanted in one eye and a blue-light filtering IOL implanted in the other. Researchers then administered the National Eye Institute Visual Functioning Questionnaire to each patient and measured bestcorrected visual acuity, color discrimination and contrast sensitivity. They found no significant differences between color vision changes, contrast sensitivity, central macular thickness or total macular volume. They did, however, find a small but 4

5 statistically significant difference in visual acuity. From this, they concluded that there was no significant difference in visual function between the two IOL groups. They also wrote that larger and long-term clinical studies are needed to evaluate hypothetical retinal protection using a blue-light filtering IOL. Hubble Lens May Be Next IOL For AMD London Eye Hospital Pharma announced today that it has initiated U.S. discussions to gain clinical data for its iolamd lens system. iolamd is a novel intraocular lens (IOL) system designed to restore lost vision and provide an independent lifestyle for patients with dry AMD and related diseases. The technology behind the iolamd lens was inspired by a method used to fix the Hubble Telescope, thus the nickname Hubble Lens. Another device, the Implantable Miniature Telescopcope (IMT), has already been approved in the U.S. to address the problem of central (macular) vision loss. But a device such as the IMT, according to researchers Dr. Bobby Qureshi and Professor Pablo Artal, requires a much larger incision through which the lens is implanted. Another difference between the IMT and the iolamd is that the IMT magnifies the visual field to encompass the peripheral vision, while the iolamd redirects the image onto the peripheral retina without significantly magnifying it. Since the peripheral retina, however, does not offer the same clarity as does the macula, acuity with either lens system will be somewhat less than perfect. Further information about the iolamd may be found at December is REWIND MONTH A chance to replay a favorite presentation from the past. We hope you will enjoy the program selected for you by your facilitator! 5