RETINA ISSUE Theth Ddevil’S Il’ Iin the H Didistant Ddetails Il P2P
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THE FLUID WAVE: EVALUATING CANAL SURGERY P. 56 • SEALANTS AND GLUES IN REVIEW P. 14 Review of Ophthalmology Vol. XXI, No. 8 • August 2014 • eld Retinal Imaging • • Treatment Widefi Optimizing Anti-VEGF Occlusion Options • Vein Syndrome Pseudoexfoliation ICD-10 POSTPONED: NOW WHAT? P. 18 • THE KEYS TO MULTIFOCAL IOL CENTRATION P. 65 MULTIMODAL RETINAL IMAGING IN PLAQUENIL TOXICITY P. 44 • WHAT’S BEHIND PXS P. 52 August 2014 • revophth.com ANNUAL RETINA ISSUE TheTh Devil’s D il’ ini the h Distant Di Details D il P2P. 266 Maximizing the Benefi ts of Anti-VEGF P. 30 Increasing Options to Treat Vein Occlusion P. 40 Also Inside: The Critical Driver of Success: Physician Time P. 22 001_rp0814_fc.indd 1 7/25/14 1:33 PM REGENERON IS COMMITTED to Retina Physician Choice Physicians need access to multiple safe and effective therapies to individualize a treatment plan for each patient Regeneron is fully committed to supporting the important work of retina physicians so that patients may receive the best care possible. We understand and respect the importance of physicians having multiple safe and effective treatment options and the ability to select treatments that are most appropriate for their patients based on clinical judgment. www.regeneron.com Copyright © 2014, Regeneron Pharmaceuticals, Inc. All rights reserved. RGN-0157D 6/2014 RP0814_Regeneron.indd 1 7/21/14 1:10 PM REVIEW NEWS Volume XXI • No. 8 • August 2014 Researchers: First Tissue Grown From Adult Human Stem Cell K Lathrop, B Ksander, M Frank and N Frank. M Frank B Ksander, K Lathrop, Boston researchers have identified a way known examples of constructing a tis- to enhance regrowth of human cor- sue from an adult-derived human stem neal tissue to restore vision, using a cell. molecule known as ABCB5 that acts as Limbal stem cells help maintain a marker for hard-to-fi nd limbal stem and regenerate corneal tissue. Their cells. This work, a collaboration be- loss due to injury or disease is one of tween the Massachusetts Eye and Ear/ the leading causes of blindness. In the Schepens Eye Research Institute, Bos- past, tissue or cell transplants have ton Children’s Hospital, Brigham and been used to help the cornea regener- Women’s Hospital and the VA Boston ate, but it was unknown whether there Healthcare System, provides promise were actual limbal stem cells in the to burn victims, victims of chemical grafts, or how many, and the outcomes A restored functional cornea following injury and others with damaging eye were not consistent. transplantation of human ABCB5-positive diseases. The research, published this In this study, researchers were able limbal stem cells to limbal stem cell- week in Nature, is also one of the fi rst to use antibodies detecting ABCB5 to defi cient mice. Transplants consisting of human ABCB5-positive limbal stem cells resulted in restoration and long-term FDA Approval for Ozurdex 0.7 mg for Select DME Cases maintenance of a normal clear cornea, whereas control mice that received either The Food and Drug Administration approved Allergan’s Ozurdex (dexamethasone intra- no cells or ABCB5-negative cells failed to vitreal implant) as a new treatment option for diabetic macular edema in adult patients restore the cornea. who have an artifi cial lens implant or who are scheduled for cataract surgery. Ozurdex is a sustained-release biodegradable steroid implant that demonstrated long-term effi cacy zero in on the stem cells in tissue from without the need for monthly injections. deceased human donors and use them DME currently impacts more than 560,000 Americans. The Ozurdex implant uses the pro- to regrow anatomically correct, fully prietary and innovative Novadur solid polymer delivery system—a biodegradable implant functional human corneas in mice. that releases medicine over an extended period of time—to suppress infl ammation, which “Limbal stem cells are very rare, plays a key role in the development of DME. The FDA approval of Ozurdex for this indication is based on the MEAD (Macular Edema: and successful transplants are depen- Assessment of Implantable Dexamethasone in Diabetes) study. MEAD includes two dent on these rare cells,” says Bruce multicenter, three-year, sham-controlled, masked, randomized clinical studies assessing Ksander, PhD, of Mass Eye and Ear, the proportion of patients with 15 or more letters improvement in best-corrected visual co-lead author on the study with post- acuity from baseline. The most common adverse events in the studies included cataracts doctoral fellow Paraskevi Kolovou, and elevated intraocular pressure. An increase in mean IOP was seen with each treatment MD. “This fi nding will now make it cycle, and the mean IOP generally returned to baseline between treatment cycles. much easier to restore the corneal sur- “DME is a complicated disease to treat,” said Pravin Dugel, MD, clinical associate face. It’s a very good example of basic professor of ophthalmology at the Keck School of Medicine at the University of Southern research moving quickly to a transla- California, managing partner of Retinal Consultants of Arizona, and clinical investigator in the MEAD clinical trial. “Ozurdex provides long-term improvement of DME without the tional application.” need for monthly injections, which helps these patients who are also managing the other ABCB5 was originally discovered conditions common with diabetes.” in the lab of Markus Frank, MD, of The Ozurdex implant is already indicated for the treatment of macular edema following Boston Children’s Hospital, and Na- branch retinal vein occlusion or central retinal vein occlusion and for the treatment of non- tasha Frank, MD, of the VA Boston infectious uveitis affecting the posterior segment of the eye. Healthcare System and Brigham and August 2014 | Revophth.com | 3 003_rp0814_news.indd 3 7/25/14 11:28 AM REVIEW News Women’s Hospital, co-senior investiga- Cataract Surgery for example, can provide benefi ts in a tors on the study, as being produced variety of ways—for people with Al- in tissue precursor cells in human skin Pays Dividends in zheimer’s and also for their caregivers and intestine. In the new work, using a from whom unnecessary burden can mouse model developed by the Frank Alzheimer’s Patients be lifted,” Dr. Carrillo said. lab, they found that ABCB5 also occurs Cataract surgery for people with Alzhei- At AAIC 2014, Alan J. Lerner, MD, in limbal stem cells and is required for mer’s disease and other dementias not of Case Western Reserve University their maintenance and survival, and for only improves vision but can slow de- and University Hospitals Case Medi- corneal development and repair. Mice cline in cognition and improve quality cal Center and colleagues reported lacking a functional ABCB5 gene lost of life for both people with the disease interim results from an ongoing clini- their populations of limbal stem cells, and their caregivers, according to clini- cal trial to determine the effects of and their corneas healed poorly after cal trial results reported in July at the cataract removal on several measures injury. Alzheimer’s Association International of visual ability, cognitive measures, “ABCB5 allows limbal stem cells to Conference 2014 in Copenhagen, and quality of life in people with survive, protecting them from apop- Denmark. dementia. Study participants are re- tosis [programmed cell death],” said “This study supports the Alzheimer’s cruited from dementia and ophthal- Markus Frank. “The mouse model Association view that people with de- mology clinics at University Hospitals allowed us for the fi rst time to under- mentia retain, and benefi t from, full Case Medical Center and Metro- stand the role of ABCB5 in normal de- health-care treatment,” said Maria Health Medical Center in Cleveland, velopment, and should be very impor- Carrillo, PhD, Alzheimer’s Association and are divided into two groups: tant to the stem cell fi eld in general,” vice president of medical and scientifi c 1) immediate surgery following re- said Natasha Frank. relations. “Too common attitudes such cruitment and; 2) delayed or refused Markus Frank is working with the as, ‘There’s no need for extra care’ or surgery. Vision and cognitive status, biopharmaceutical industry to devel- ‘Why put them through all of that’ are mood and capability to complete dai- op a clinical-grade ABCB5 antibody not justifi ed and are bad medical prac- ly activities are evaluated at baseline that would meet U.S. regulatory ap- tice.” and six months after recruitment, or provals. “A single lab cannot do a “Appropriate thoughtfulness and re- six months after surgery. study like this,” said Natasha Frank, straint are necessary when considering Preliminary analysis of results from also affi liated with the Harvard Stem surgery or other procedures for people 20 surgical and eight non-surgical Cell Institute. “It integrates genetics, with Alzheimer’s or another dementia. participants showed that the surgi- knockout mice, antibodies, transplan- However, we should not assume that cal group had signifi cantly improved tation—a lot of technical expertise medical procedures cannot be pur- visual acuity and quality of life, re- that we were lucky came together in sued or are too risky. As these new re- duced decline in memory and execu- a very nice way.” sults show, improving sensory abilities, tive functioning, and improvements in behavioral measures compared with Expanded Approval for B + L Victus the non-surgical group. Levels of per- Bausch + Lomb has received 510(k) Institute, Bloomington, Minn. “In lower ceived burden for caregivers of peo- clearance from the FDA for the Victus Fem- grade cataracts, we have seen up to a ple in the surgical group also showed tosecond Laser Platform for laser-assisted 50-percent reduction in the phaco energy improvement.