Dual Antagonism of PDGF and VEGF in nAMD Degeneration
Incidence & Causes of Vision Loss During Aflibercept Treatment for nAMD
Incidence & Growth of GA: Five Years of AMD Treatment Trials
OCT-reflective Drusen Substructure Prediction of Progression to AMD
Intravitreal Ranibizumab & Oral DHA Supplementation Plus Antioxidants for DME
Total Retinectomy in Cases With Advanced Proliferative Vitreoretinopathy
Topical Apraclonidine for Pain Reduction After Intravitreal Injections
Correlation of Microvascular Structures on OCTA With VA in RVO
Nondamaging Retinal Laser Therapy for Treatment of CSC
OCT of Retinal Lesions in Infants With Congenital Zika Syndrome
Relationship Between Macular Thickness Measurement and Signal Strength on OCT
Stealth Initiates Phase I Study of Elamipretide in Dry AMD
Stealth BioTherapeutics announced the initiation of ReCLAIM, a Phase I study evaluating elamipretide in intermediate age-related macular degeneration. Top-line data are expected mid-year 2017. ReCLAIM is an open-label study to evaluate the safety and tolerability of 12 weeks of treatment with daily subcutaneous injections of elamipretide in individuals age 55 and above who have at least one eye with intermediate AMD, and have either drusen on the retina without any geographic atrophy or noncentral GA. The study's primary endpoints are safety and tolerability, and the secondary endpoints are changes from baseline in physical/ophthalmic exams and feasibility of subcutaneous injections in this population. Read more.
Source: Stealth BioTherapeutics, November 2016
Actemra Found Superior to Steroids Alone for Steroid-free Remission of Giant Cell Arteritis
Genentech, a member of the Roche Group, announced positive results from the Phase III GiACTA study that evaluated Actemra (tocilizumab) in people with GCA. GiACTA met its primary and key secondary endpoint, demonstrating that Actemra, initially in combination with a six-month steroid (glucocorticoid) taper, enabled significantly more individuals to achieve sustained disease remission while also significantly reducing steroid exposure compared with steroids alone. The primary endpoint was met, with Actemra significantly increasing the proportion of individuals achieving sustained remission at one year (56 percent [QW; p<0.0001] and 53.1 percent [Q2W; p<0.0001]) vs. 14 percent with a six-month steroid taper regimen given alone. The study also met its key secondary endpoint, demonstrating that Actemra significantly increased the proportion of people achieving sustained remission at one year (56 percent [QW; p<0.0001] and 53.1 percent [Q2W; p=0.0002]) compared to 17.6 percent with a 12-month steroid taper regimen given alone. Read more.
Source: Genentech, November 2016
OCULAR THERAPEUTIX ANNOUNCES POSITIVE TOPLINE RESULTS FROM PHASE III TRIAL
Ocular Therapeutix announced positive topline results from its Phase III clinical trial of Dextenza (dexamethasone insert) 0.4 mg for the treatment of post-surgical ocular inflammation and pain. Dextenza is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days. The trial successfully met its two primary efficacy endpoints for inflammation and pain, achieving statistically significant differences between the treatment group and the placebo group for the absence of inflammatory cells on day 14 and the absence of pain on day eight, respectively. A total of 52.3 percent of individuals treated with Dextenza showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14 compared with 31.1 percent of those receiving the placebo vehicle control punctum plug (p<0.0001). Read more.
Source: Ocular Therapeutix, November 2016
RP May Be Treated by Reprogramming Sugar Metabolism
Columbia University Medical Center researchers have demonstrated that vision loss associated with a form of retinitis pigmentosa can be slowed dramatically by reprogramming the metabolism of photoreceptors in the retina. The study, conducted in mice, represents a novel approach to RP treatment in which the therapy aims to correct downstream metabolic aberrations of the disease rather than the underlying genetic defect. The findings were published online in the Journal of Clinical Investigation. In an earlier paper, researchers theorized that rods deteriorate in RP in part because of an inability to use glucose to rebuild the rods’ outer segment. “We hypothesized that diseased rods could be rescued by reprogramming sugar metabolism,” said Stephen H. Tsang, MD, PhD, László Z. Bitó associate professor of ophthalmology, Pathology & Cell Biology, Columbia University. Dr. Tsang tested this hypothesis in mice with a mutation in the Pde6 gene that disrupts rod metabolism, leading to an RP-like disorder. The mice were treated so that their rods could not express Sirt6, a gene that inhibits sugar metabolism. Examination of photoreceptors with electroretinography showed the mice had significantly greater measures of rod and cone health than untreated controls. Overall, the metabolomes of the treated mice had accumulated the molecules needed to build the outer segment and rods and cones survived longer in the treated mice than in the controls. While the treatment significantly prolonged survival of the diseased rods and cones, it didn’t prevent their eventual death. Dr. Tsang said the team’s next challenge is to figure out how to extend the therapeutic effect of Sirt6 inhibition. Read more.
Source: Columbia University Medical Center, November 2016
New Protein Offers Link Between Aging & Macular Degeneration
The discovery of a novel protein that links aging and age-dependent retinal diseases could lead to potential new treatments for conditions that cause sight loss in later life. In a study in mice, to be published in the eLife, researchers from the University of Wisconsin-Madison reveal that Transmembrane 135 regulates retinal aging and that mutations in the protein result in age-dependent disease. Tmem135 has previously been associated with fat storage and long life in the roundworm Caenorhabditis elegans, but its molecular function has never been characterized clearly. The new study shows that irregular levels of the protein lead to symptoms of macular degeneration. The team of researchers studied mouse models that exhibit retinal abnormalities similar to those seen in normal-aged mice, but with earlier onset and faster development. Genetic mapping revealed that the mutation in Tmem135 caused these symptoms. The team also discovered that the protein regulated the size of the mitochondria, an energy-producing organelle essential for various metabolic functions of cells. The team aims to determine the exact biochemical and molecular functions of Tmem135 in mitochondria and to examine its roles in the aging process of other tissues and various age-dependent diseases. Read more.
Source: eLife Sciences Publications, November 2016
Upstate Discovery Advances Understanding of Retinal Cell Formation
SUNY Upstate Medical University researchers Andrea S. Viczian, PhD, and Michael E. Zuber, PhD, and colleagues, have advanced understanding of how retinal cells are formed by identifying two genes—Tbx3 and Pax6—that start the process of eye development. Their discovery could play a role in how retinal diseases such as age-related macular degeneration, diabetic retinopathy and retinitis pigmentosa might be treated. The findings were recently published in Development. Eye field transcription factors are a group of seven genes that work together and are required for the formation of a normal eye. Prior to the researchers’ discovery, it was assumed that all seven EFTFs were required to start eye formation. In their study, the team used frog embryos, whose retinas develop in a similar manner and contain the same retinal cell types as those of the human retina. They found that only two of the seven EFTFs, Tbx3 and Pax6, were necessary to start the process of eye formation and the retina. With further study, the discovery may also be translated into generating retinal cells in culture for therapeutic use. Read more.
Source: SUNY Upstate Medical University, October 2016
REPORT EXPLORES GAP BETWEEN MANAGED CARE & ECPS
Care Trend Report, Volume II, supported by Allergan, is a 40-page report that examines and compares the perspectives of managed care organizations, ophthalmologists and optometrists on current eye-care issues. Findings from three surveys are analyzed along with commentary from an independent Editorial Advisory Panel of 10 managed-care and eye-care experts. A total of 83 MCOs, 65 ophthalmologists and 127 optometrists completed the three surveys. Findings include: MCOs name the rising cost of care as the leading challenge in eye care, while ophthalmologists and optometrists cite decreasing reimbursements as the top challenge; and approximately three-quarters of ophthalmologists (n=64) and optometrists (n=127) agree that a patient’s health plan formulary has a great or moderate influence on prescribing decisions. Read more.
Source: Allergan, November 2016
Researchers Initiate Phase II Gene Therapy Trial for Choroideremia
Following a successful Phase I gene therapy trial for choroideremia, Robert MacLaren, professor of Ophthalmology at University of Oxford, and his team initiated a Phase II trial enrolling 30 subjects in which Professor MacLaren is using an operating microscope with integrated optical coherence tomography that will refine the surgery integral to gene replacement therapy. The OPMI Lumera 700 Rescan purchase is the result of a number of donors, including: Fight for Sight; Tommy Salisbury Choroideremia Fund at Fight for Sight; National Eye Research Centre; Choroideremia Research Foundation USA; Saturday Hospital Fund; and benefactors of the MacLaren Group. The intraoperative OCT microscope enables surgeons to track changes in the retinal anatomy in real time, and enable safe and precise delivery of the gene therapy with the goal of improved vision for patients. Read more.
Source: Oxford Clinical Trials Research Unit, November 2016
SECOND SIGHT ANNOUNCES CMS HOSPITAL OUTPATIENT RATE FOR ARGUS II CPT CODES
Second Sight Medical Products announced that the Centers for Medicare & Medicaid Services finalized its Medicare hospital outpatient payment rate of $150,000.50 for 2017, which includes the cost of the Argus II Retinal Prosthesis System. In addition, the company announced that the American Medical Association Current Procedural Terminology Editorial Panel approved two new Category III CPT codes for initial programming and subsequent reprogramming of the Argus II. The codes will be published on January 1, 2017, and can be reported by clinicians beginning on July 1, 2017. Read more.
Source: Second Sight, November 2016
AGTC FILES IND FOR TREATMENT OF ACHROMATOPSIA DUE TO CNGA3 MUTATIONS
Applied Genetic Technologies Corp. filed an Investigational New Drug application with the U.S. Food and Drug Administration to conduct a Phase I/II clinical trial of the company's gene therapy product candidate for the treatment of achromatopsia caused by mutations in the CNGA3 gene. The Company previously initiated a Phase I/II clinical trial of its gene therapy product for the treatment of achromatopsia caused by mutations in the CNGB3 gene, and plans to initiate a clinical study evaluating the safety and efficacy of the therapy product for CNGA3-related achromatopsia in the United States in upcoming months. Read more.
Source: AGTC, October 2016
SPARK COLLABORATES WITH UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL GENE THERAPY CENTER
Spark Therapeutics announced a multiyear research agreement with Guangping Gao, PhD, the Penelope Booth Rockwell Chair in Biomedical Research, director of the Horae Gene Therapy Center, and professor of microbiology and physiological systems at the University of Massachusetts Medical School. Dr. Gao will collaborate with Spark Therapeutics to identify adeno-associated virus vectors from a proprietary library of AAV capsids and evaluate their efficacy, with the goal of enhancing the efficiency of gene delivery to cells in the retina, liver and central nervous system. Read more.
Source: Spark Therapeutics, October 2016
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