Treat-and-extend vs. Monthly Dosing for nAMD: TREX-AMD Study
High-dose Aflibercept for Recalcitrant nAMD Intravitreal Ranibizumab’s Effect on Ocular Circulation of Untreated Fellow Eyes Bevacizumab Injection in nAMD Increases Angiogenic Biomarkers AMD in Chronic Myeloproliferative Neoplasms Nonperfusion Area on Ultra-wide Field FA in Eyes with DME: DAVE Study Scientists examined the distribution of nonperfusion area in eyes with diabetic macular edema and its relationship to the severity of DME, as part of a prospective, observational case series. Forty eyes of 29 individuals with treatment-naïve DME who participated in the DAVE study were included. Ultra-wide field fluorescein angiography images were sent to the Doheny Image Reading Center to be montaged and adjusted by stereographic projection for peripheral distortion. Two experienced, independent/masked certified graders manually segmented the NPA and total visible retinal area, and computed the NPA and TRA in mm2. They calculated the ischemic index, and correlated the distribution of NPA and ISI within different retinal zones with the severity of DME. In 40 eyes of treatment-naïve DME subjects (mean age: 55.8 years), visual acuity (mean 59.6 EDTRS letters) was correlated with central macular thickness (mean 536.9 μm, r=-0.418, p=0.008) and macular volume (mean 11.9 mm3, r=-0.449; p=0.004). The NPA and ISI among the different retinal zones were significantly different (NPA: p<0.001; ISI: p=0.005). The NPA and ISI in the mid-periphery were negatively associated with CMT (NPA: p=0.04; ISI: p=0.02). However, the global NPA and ISI for the entire retina weren’t associated with CMT or MV (p>0.05). Scientists concluded that, in eyes with DME, the ISI increased with greater distance from the fovea. They added that DME severity didn’t appear to correlate with global NPA and ISI. SOURCE: Fan W, Wang K, Ghasemi Falavarjani K, et al. Distribution of nonperfusion area on ultra-wide field fluorescein angiography in eyes with diabetic macular edema: DAVE study. Am J Ophthalmol 2017; Jun 1. [Epub ahead of print]. Differential Microvascular Assessment of RVO With OCTA & FA Ranibizumab vs. Dexamethasone Implants for CRVO: The RANIDEX Study Vision-related Quality of Life for Noninfectious Uveitis Treated With Fluocinolone Acetonide Implants or Systemic Corticosteroid Therapy Systematic Increase of Corticosteroid-related AEs in Noninfectious Intermediate, Posterior or Panuveitis |
NOVARTIS RTH258 (BROLUCIZUMAB) DEMONSTRATES VISUAL GAINS IN NAMD Novartis reported that RTH258 (brolucizumab) 6 mg met the primary and key secondary endpoints in two Phase III studies, HAWK and HARRIER. RTH258 3 mg, evaluated in HAWK, also met these endpoints. The studies enrolled more than 1,800 individuals with neovascular age-related macular degeneration across 400 centers worldwide. The primary and key secondary efficacy endpoints were non-inferiority of RTH258 to aflibercept in mean change in best-corrected visual acuity from baseline to week 48, and average mean change over the period of weeks 36 to 48, respectively. Both endpoints were met with highly significant p values. RTH258 was generally well-tolerated, with overall ocular and systemic adverse event rates comparable to aflibercept. RTH258 demonstrated long-lasting efficacy vs. aflibercept dosed every eight weeks. Read more. Source: Novartis, June 2017 Neurotech Reveals Positive Phase II Results in NT-501 for Macular Telangiectasia Neurotech Pharmaceuticals, in collaboration with the Lowy Medical Research Institute, announced 24-month results demonstrating that NT-501 delivering ciliary neurotrophic factor had a beneficial effect in individuals with macular telangiectasia type 2. The multicenter, randomized clinical trial demonstrated a statistically significant reduction in the progressive loss of photoreceptors in treated vs. untreated eyes. NT-501 utilizes the company's proprietary Encapsulated Cell Therapy platform, which can be customized to deliver specific therapeutic molecules to the back of the eye for retinal disease. The Phase II study enrolled 67 individuals (99 eyes) at eight sites in the United States, and three people in Australia. Read more. Source: Neurotech Pharmaceuticals, June 2017 pSivida's Durasert for Posterior Segment Uveitis Achieves Primary Efficacy Endpoint in Phase III Study pSivida announced that the company's second Phase III trial of Durasert three-year treatment for posterior segment uveitis achieved the trial's primary endpoint. The study involving 153 participants had a primary endpoint of preventing recurrence of posterior uveitis at six months, with individuals followed for 36 months. The three-year inserts demonstrated a significant reduction in the recurrence of posterior segment uveitis through six months: 21.8 percent of Durasert-treated individuals had a recurrence vs. 53.8 percent of people in the sham group (p<0.001). Read more. Source: pSivida, June 2017 Aerpio Initiates Patient Dosing in TIME Phase IIb Study of AKB-9778 in Diabetic Retinopathy Aerpio Pharmaceuticals began patient dosing in the company’s TIME Phase IIb clinical trial to assess the efficacy and safety of lead candidate AKB-9778 for individuals with moderate to severe non-proliferative diabetic retinopathy. The double-masked, placebo-controlled, multicenter trial will enroll 150 individuals randomized 1:1:1 to receive either AKB-9778 15 mg subcutaneously once daily, AKB-9778 15 mg twice daily or placebo for a 12-month period. The primary endpoint is the percentage of individuals who improve by at least two steps in diabetic retinopathy Severity Score in the study eye. Secondary objectives include assessment of safety and tolerability of both dosing regimens. Read more. Source: Aerpio Pharmaceuticals, June 2017 SECOND SIGHT EXPANDS MEDICARE COVERAGE FOR ARGUS II, ENTERS SOUTH KOREAN MARKET Second Sight Medical Products announced the Argus II Retinal Prosthesis System is now covered by Medicare in seven of the 12 Medicare Administrative Contractor jurisdictions nationwide, representing a total of 28 states, two territories and the District of Columbia. Read more. The company also entered the South Korean market and implanted the Argus II Retinal Prosthesis System in two individuals in Seoul, with a second patient in Taiwan receiving the company’s Argus II. Read more. Source: Second Sight, July 2017 PROQR CANDIDATE QRX-411 RECEIVES ORPHAN DRUG DESIGNATION FROM FDA & EMA ProQR Therapeutics’ investigational drug QRX-411 received orphan drug designation from the U.S. Food and Drug Administration and European Medicines Agency for the treatment of retinitis pigmentosa, including Usher syndrome, the subtype targeted by QRX-411. Read more. Source: ProQR Therapeutics, July 2017 FDA Rejects Ocular Therapeutix Resubmission of Dextenza NDA In a Complete Response Letter to Ocular Therapeutix regarding its resubmission of a New Drug Application for Dextenza (dexamethasone insert) 0.4mg for the treatment of ocular pain following ophthalmic surgery, the U.S. Food and Drug Administration stated it could not approve the NDA in its present form. The CRL referred to deficiencies in manufacturing processes and analytical testing related to the manufacture of drug products for commercial production identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility completed in May 2017. Read more. Source: Ocular Therapeutix, July 2017 Novaliq Appoints Dr. Burian as CMO Novaliq named Gabriela Burian, MD, MPH, Novaliq’s chief medical officer. Previously, Dr. Burian served as global program medical director at Novartis Pharma and early program leader at F. Hoffmann-La Roche. She founded and directs GB Biomed Advisors, and serves as CMO for Iconic Therapeutics. Read more. SOURCE: Novaliq, June 2017 AGTC REPORTS POSITIVE TOPLINE DATA FOR X-LINKED RETINOSCHISIS STUDY Applied Genetic Technologies announced positive topline safety data for the dose-escalation phase of the company’s Phase I/II X-linked retinoschisis clinical trial, a program partnering with Biogen. The first 12 subjects enrolled in low-, middle- and high-dose groups were followed for more than a year. Mild to moderate ocular inflammation was observed in the treated eyes of most individuals and resolved without further intervention, or was controlled with topical or oral corticosteroids, AGTC says. No treatment-related serious adverse events were reported, and the treatment was generally well-tolerated. Read more. Source: AGTC, June 2017 REGENXBIO INITIATES PHASE I TRIAL OF RGX-314 GENE THERAPY FOR WET AMD Regenxbio announced that the first patient was dosed in a Phase I clinical trial evaluating RGX-314 for individuals with wet age-related macular degeneration. This multicenter, open-label, multiple-cohort, dose-escalation clinical trial will assess the safety and tolerability of RGX-314 as a one-time therapy for individuals with previously treated wet AMD. The therapeutic option is designed to be a one-time treatment for wet AMD administered subretinally to yield local production of an anti-VEGF antibody fragment, potentially eliminating the need for additional anti-VEGF administrations. Read more. Source: Regenxbio, May 2017 VITAL ART AND SCIENCE ANNOUNCES LICENSING AGREEMENT WITH GENENTECH Vital Art and Science signed a license agreement with Genentech for the use of its mVT app service in Genentech’s ophthalmology clinical studies. Genentech intends to use the service to enhance patient experience, improve the effectiveness of patient interactions with health-care providers, and apply the data collected through the service to improve patient care and clinical trial design. The app is currently being used in Genentech’s Phase II LADDER study investigating the sustained delivery of Lucentis (ranibizumab injection) via Genentech’s Port Delivery System in individuals with wet age-related macular degeneration. Read more. Source: Vital Art and Science, June 2017
HADASIT AND BIOTIME COMPLETE SHARE SWAP TRANSACTION Hadasit Bio-Holdings completed a share swap transaction with BioTime in joint portfolio company Cell Cure Neurosciences, a biotechnological company focusing on developing cell therapy for degenerative retinal and macular diseases. Its technology is based on human embryonic stem cells, which can be produced on a mass scale for any cell of the human body. BioTime is a clinical-stage biotechnology company focused on developing and commercializing novel therapies developed from pluripotent cell assets. Read more. Source: Hadasit Bio-Holdings and BioTime, June 2017 SHIRE NAMES SNISARENKO TO SUCCEED DEMPSEY AS HEAD OF U.S. OPHTHALMICS Shire announced that John Snisarenko was named group vice president and head of ophthalmics in the United States. He succeeds Robert Dempsey, who is now vice president and head of global ophthalmics at Shire. Snisarenko brings 30 years of experience in the pharmaceutical, biotech and medical device industries. Most recently, Snisarenko was vice president of sales and marketing for rheumatology at Genentech, where he worked on the drugs Actemra and Rituxan. Prior to that, he led sales and marketing for Genentech ophthalmology in the United States. There, he was part of the team that introduced the “Commitment to Retina” initiative, and was involved with Lucentis. Earlier in his career at Novartis Pharma Canada, Snisarenko led the integration of the ophthalmology business from CIBA Vision to Novartis Pharma. He also led the Canadian launch of the unit’s first bio-pharmaceutical medicine, Visudyne. Source: Shire, June 2017 |
Review of Ophthalmology's® Retina Online is published by the Review Group, a Division of Jobson Medical Information LLC (JMI), 11 Campus Boulevard, Newtown Square, PA 19073. To subscribe to other JMI newsletters or to manage your subscription, click here. To change your email address, reply to this email. Write "change of address" in the subject line. Make sure to provide us with your old and new address. To ensure delivery, please be sure to add reviewophth@jobsonmail.com to your address book or safe senders list. Click here if you do not want to receive future emails from Review of Ophthalmology's Retina Online. |