Ranibizumab and Aflibercept in AMD: Time to Retreatment and Visual Function
Intravitreal Aflibercept for DME: 148-Week Results From VISTA and VIVID Studies
Outcomes of Ranibizumab for DME: Protocol 3 With High-dose (READ-3) Study
Anatomical Relationships Between Retinal Neovascularization & Posterior Vitreous in PDR
Using OCTA for Follow-up of RVO Treated With Anti-VEGF
Intravitreal Ziv-Aflibercept for ME Following Retinal Vein Occlusion
Volume-Rendered Angiographic and Structural OCTA of Type 2 Macular Telangiectasia
Risk of Recurrence After Primary Rhegmatogenous RD Repair
Diagnostic Clinical Exam Findings vs. Telemedicine Evaluation of Acute ROP
Data Reinforce Efficacy of Voretigene Neparvovec in RPE65-Mediated IRD
Spark Therapeutics announced that Albert M. Maguire, MD, professor of ophthalmology at the Perelman School of Medicine of the University of Pennsylvania, presented one-year efficacy data from the crossover group and two-year durability data from the original intervention group for the Phase III trial of voretigene neparvovec (formerly SPK-RPE65) during Retina Subspecialty Day at the American Academy of Ophthalmology annual meeting in Chicago. Dr. Maguire is the study's principal investigator. Voretigene neparvovec, an investigational gene therapy for inherited retinal disease caused by mutations in the RPE65 gene, has received both breakthrough therapy and orphan product designations from the U.S. Food and Drug Administration, as well as orphan product designations from the European Medicines Agency. Results from the ongoing Phase III trial of voretigene neparvovec showed that 93 percent of subjects, including those in the original control group who crossed over to receive intervention, demonstrated a gain in functional vision, and maintained that improvement over one year following the procedure, Dr. Maguire reported at the meeting. Additionally, he said the original intervention group sustained its year-one improvement at year two. He said further the data bolsters the growing dataset supporting voretigene neparvovec. Read more.
Source: Spark Therapeutics, October 2016
Eye Test May Detect Parkinson’s Before Symptoms Appear
A new noninvasive eye test could detect Parkinson’s disease before symptom onset, according to research in rats led by scientists at University College London Institute of Ophthalmology. Researchers discovered a new way to observe changes in the retina in advance of brain changes and symptoms onset caused by the Parkinson’s. Using ophthalmic instruments routinely used in eye clinics, the scientists used a new imaging technique to observe retinal changes at an early stage. This method, published in Acta Neuropathologica Communications, would enable earlier diagnosis of Parkinson’s and monitoring of patient response to treatment. The technique—for which one of the researchers holds the patent—has been tested in humans for glaucoma, and trials are expected to start for Alzheimer’s. Following the observation of retinal changes in the experimental model, researchers treated animals with a newly formulated version of the anti-diabetic drug Rosiglitazone, which helps to protect nerve cells. After using the drug, evidence of reduced retina cell death, as well as a protective effect on the brain, was observed, suggesting the drug could have potential as a treatment for Parkinson’s disease. Read More.
Source: University College London, August 2016
Abicipar Pegol PALM Study Phase II Data Presented at AAO Annual Meeting
Molecular Partners AG announced that Tarek S. Hassan, MD, professor of ophthalmology at Oakland University William Beaumont School of Medicine, and senior partner and director of the vitreoretinal fellowship training program at Associated Retinal Consultants in Royal Oak, Mich., presented data from PALM, a multicenter, double-masked, Phase II clinical trial evaluating Abicipar Pegol for diabetic macular edema, at the American Academy of Ophthalmology annual meeting in Chicago. A total of 151 individuals with DME (best-corrected visual acuity ≤75 and ≥24 letters) were enrolled. The efficacy of abicipar was demonstrated in all treatment groups. Abicipar 2 mg (q8 weeks and q12 weeks, following three monthly loading doses) demonstrated functional (BCVA) and anatomical (central retinal thickness) effects comparable with monthly ranibizumab, and with fewer injections over a 28-week period. The most common ocular adverse events were vitreous floaters and conjunctival hemorrhage in the abicipar arms. Intraocular inflammation occurred in seven, five and four individuals treated with abicipar 1 q8, 2 q8 and 2 q12 groups, respectively, and no individuals treated with ranibizumab. The events were mostly mild to moderate in severity, and resolved with treatment. Allergan is currently enrolling patients in a Phase III trial for AMD using an updated formulation of abicipar, and topline results are expected in 2018. Molecular Partners exclusively licensed abicipar to Allergan in May 2011. Read more.
Source: Molecular Partners AG, October 2016
Co-formulated Aflibercept Shows No Benefit Over Aflibercept Alone for nAMD
Regeneron Pharmaceuticals announced topline results from the Phase II CAPELLA study evaluating aflibercept co-formulated with rinucumab, an anti-platelet-derived growth factor receptor beta antibody, in individuals with neovascular age-related macular degeneration. The combination therapy did not demonstrate an improvement in best-corrected visual acuity compared with intravitreal aflibercept injection monotherapy at 12 weeks, the primary endpoint of the study. At 12 weeks, individuals in both combination aflibercept/rinucumab groups showed a 5.8-letter improvement in BCVA. Those treated with aflibercept alone showed a 7.5-letter improvement in BCVA. Eylea results in this study were consistent with the efficacy and safety seen in the drug’s Phase III pivotal studies in wet AMD. The efficacy results in the CAPELLA trial were consistent across all choroidal neovascularization subtypes. Adding rinucumab to aflibercept showed no benefit on anatomic endpoints including reduction in retinal thickness or in resolution of subretinal hyperreflective material. Read more.
Source: Regeneron Pharmaceuticals, September 2016
Ocular Therapeutix and Regeneron Enter into Strategic Collaboration
Ocular Therapeutix entered into a strategic collaboration, option and license agreement with Regeneron Pharmaceuticals. The companies will collaborate on the development of a sustained release formulation of the vascular endothelial growth factor trap aflibercept for the treatment of wet age-related macular degeneration and other serious retinal diseases. This formulation is in preclinical development. Regeneron’s aflibercept is approved by the U.S. Food and Drug Administration for certain indications under the brand name Eylea. Ocular Therapeutix is developing proprietary sustained-release hydrogel-based drug delivery depots for intravitreal injection that can be formulated with small and large molecule pharmaceuticals, such as tyrosine kinase inhibitors and protein-based anti-VEGFs, with the goal of delivering sustained and therapeutic levels of drugs to targeted ocular tissues. Read more.
Source: Ocular Therapeutix, October 2016
UAB Researchers Look at DR Screening Follow-up Adherence
University of Alabama at Birmingham researchers Cynthia Owsley, PhD, the Nathan E. Miles Chair of Ophthalmology in the UAB Department of Ophthalmology, and UAB School of Medicine student Zachary Keenum are trying to determine the extent that county clinic patients with diabetes in a diabetic retinopathy screening program adhere to the timetable of recommended follow-up eye exams. The American Diabetes Association and the American Academy of Ophthalmology Retina Panel recommend annual dilated eye examination for people with diabetes, beginning five years after diagnosis for type 1 diabetes and at the time of diagnosis, and annually thereafter for type 2 diabetes. The study found that an estimated two-thirds of individuals with self-reported diabetes receive an annual dilated eye exam, and those annual use estimates were even lower among African-Americans. The study, published in JAMA Ophthalmology, was funded by the Centers for Disease Control and Prevention. Read more.
Source: University of Alabama at Birmingham, September 2016
EyeGate Receives Additional Milestone Payment from Valeant
EyeGate Pharmaceuticals received an additional development milestone payment from a subsidiary of Valeant Pharmaceuticals International under the company’s license agreement with Valeant, pursuant to which EyeGate granted Valeant exclusive, worldwide commercial and manufacturing rights to the company’s EyeGate II Delivery System and EGP-437 combination product in the field of uveitis, as well as a right of last negotiation to license the product for other indications. The company is eligible to receive milestone payments totaling up to $32.5 million upon and subject to the achievement of certain specified development-based and commercial milestones. Read more.
Allegro Ophthalmics Enrolls Last Patient in Pacific Phase IIb Luminate Trial
Allegro Ophthalmics completed enrollment in its PACIFIC Phase IIb clinical trial that is evaluating the safety and efficacy of Luminate (ALG-1001) in inducing posterior vitreous detachment in individuals with non-proliferative diabetic retinopathy. PACIFIC is the third Phase II study of Luminate to complete enrollment. Top-line results are anticipated to be available within the first half of 2017, and those from the DEL MAR Phase IIb trials evaluating Luminate in patients with diabetic macular edema are expected in the fourth quarter of 2016. PACIFIC is a double-masked, placebo-controlled, randomized, multicenter, dose-ranging trial to evaluate intravitreal injections of Luminate in individuals with non-proliferative DR. Read more.
Source: Allegro Ophthalmics, LLC, October 2016
Opthea's Phase I Data Presented at EURETINA Congress
Opthea Limited announced that data from its Phase I clinical trial of OPT-302 was presented at the European Society of Retina Specialists Congress on Sept. 10, in Copenhagen, Denmark. OPT-302 is Opthea's lead program, a novel VEGF-C/D “Trap” therapy for wet age-related macular degeneration. The presentation provided an overview of the scientific rationale for targeting VEGF-C/D for the treatment of wet AMD along with recently announced positive data from Opthea's ongoing first-in-human clinical trial of OPT-302. The initial results have demonstrated safety and tolerability of OPT-302 administered as a monotherapy and in combination with standard-of-care Lucentis, and may suggest that combined administration of OPT-302 plus Lucentis could lead to improved clinical outcomes over Lucentis alone. Read more.
Source: Opthea, September 2016
Study Demonstrates Gene Delivery Feasibility for Inherited Retinal Degeneration
Researchers have demonstrated the ability to deliver a fully functional copy of the CLN3 gene to stem cells of patients with juvenile neuronal ceroid lipofuscinoses (NCL), one of a group of inherited neurodegenerative disease in which a mutation in the CLN3 gene causes early-onset, severe central vision loss. The gene therapy restored production of CLN3 protein in the stem cell-derived retinal neurons, as described in an article in Human Gene Therapy. Researchers from University of Iowa, Iowa City, described the gene augmentation method they developed using an adeno-associated virus vector carrying the full-length coding sequence of human CLN3 to deliver the gene to induced pluripotent stem cells derived from individuals' fibroblasts. The researchers also demonstrated the safety of AAV2-CLN3, which reportedly produced no toxicity when injected into the retinas of mice. They proposed that their findings support initiation of a clinical trial using AAV-mediated gene augmentation to treat children with CLN3-associated retinal degeneration. Read more.
Source: Mary Ann Liebert Inc. Publishers, September 2016
HealthFair Mobile Health Units Transition to IRIS Handheld Retinal Screening
Intelligent Retinal Imaging Systems signed an exclusive agreement with HealthFair, a health and wellness company, to provide its diabetic retinal exam solution on HealthFair mobile health units across the United States. HealthFair is utilizing IRIS' FDA-cleared, cloud-based service to improve quality and access to DR exams, and to reduce costs for DR exams
Source: Intelligent Retinal Imaging Systems, September 2016
Retina World Congress Releases Full Meeting Agenda
The Retina World Congress, a collaboration of international retina societies, announced publication of its preliminary full agenda for the inaugural meeting, to be held February 23 to 26, 2017, at the Marriott Harbor Beach in Fort Lauderdale, Fla. RWC will offer a variety of formats, including podium presentations, panel discussions, video segments, case-study presentations, debates and abstract presentations. Topics will cover a range of disease states, therapeutic and surgical innovations, and scientific advances. At least 100 U.S. and international speakers have been confirmed for the meeting. Read more.
Source: Retina World Congress, October 2016
SalutarisMD Honored With Azbio Fast Lane Award
As it prepares for its commercial product launch in Europe and new clinical studies in the United States, SalutarisMD received the AZBio Fast Lane Award. SalutarisMD is a pre-revenue medical device company developing an investigational ophthalmic treatment for wet age-related macular degeneration. The company’s patented technology incorporates a minimally invasive, single-use brachytherapy procedure that can be performed in an outpatient setting in approximately 15 minutes. Read more.
Source: SalutarisMD, September 2016
pSivida Strengthens Board With Leading Ophthalmologist
pSivida announced the appointment of retinal specialist Jay S. Duker, MD, to the company’s board of directors. Dr. Duker is director of the New England Eye Center, and professor and chairman of ophthalmology at Tufts Medical Center and Tufts University School of Medicine. He’s published nearly 200 peer-reviewed journal articles and authored four books on ophthalmology. Dr. Duker also serves on the editorial boards of three ophthalmic journals, is a director of Eleven Biotherapeutics and is co-founder and director of Hemera Biosciences. Read more.
Source: pSivida Corp., September 2016
CDI Launches Opsis Therapeutics to Develop Cell Therapies for Retinal Diseases
Cellular Dynamics International, a developer and manufacturer of induced pluripotent stem cell products, announced a new venture, Opsis Therapeutics, focused on discovering and developing novel medicines to treat patients suffering from retinal diseases. The venture was founded in partnership with David Gamm, MD, PhD, a pioneer in the differentiation and transplantation of iPSC-derived retinal cells. Opsis Therapeutics will develop new approaches to treating retinal diseases and associated vision loss, and develop a pipeline of therapeutic candidates in conjunction with CDI’s “haplobanking” position in human leukocyte antigen, which enables therapeutic cells to be matched to a patient's immune system, potentially avoiding the need to co-administer immune-suppressing drugs. Read more.
Source: Oculis, August 2016
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