Volume 16, Number 50
Monday, December 12, 2016


In this issue: (click heading to view article)
######### Impact of Extent of Incision in Schlemm’s Canal on Suture Trabeculotomy Outcomes
######### Ranibizumab for Vascularized Pigment Epithelial Detachment
######### Radial Peripapillary Capillary Density in Normal Retina Using OCTA
######### Incidence & Risk Factors for Developing DR Among Juvenile Type 1 & Type 2 Diabetes


Impact of Extent of Incision in Schlemm’s Canal on Suture Trabeculotomy Outcomes

Researchers examined the relationship between the extent of the incision in Schlemm’s canal during suture trabeculotomy (S-LOT) for open-angle glaucoma and the associated reduction in intraocular pressure.

They studied 48 consecutive eyes (primary OAG: 28; exfoliation glaucoma: 20) scheduled to undergo S-LOT and planned a 320-degree opening in Schlemm’s canal when total circumferential cannulation was achieved and the remaining 40-degree region under the scleral flap was not incised. When cannulation was incomplete, they incised canal up to the point reached by the cannula, and measured the extent of the incision. They performed logistic regression analysis to identify potential predictors of surgical success (IOP ≤15 mmHg).

A 320-degree incision was achieved in 23 eyes; the mean extent of the incision was 275 ±52.3 degrees. The mean IOP fell from 34 ±8.8 mmHg at baseline to 14.5 ±4 mmHg at one year postoperatively (p<0.0001). An IOP reduction of ≥30 percent was achieved in 46 eyes. Simple correlation analysis indicated that the extent of the incision in degrees did not correlate with IOP or with the reduction in IOP at one year postoperatively (p=0.7665 and 0.693, respectively). Researchers found lower preoperative IOP values and concomitant cataract extraction to be associated with surgical success.

They concluded that the extent of the incision in Schlemm’s canal during S-LOT didn’t correlate with postoperative reduction in IOP.

SOURCE: Manabe SI, Sawaguchi S, Hayashi K, et al. The effect of the extent of the incision in the Schlemm’s canal on the surgical outcomes of suture trabeculotomy for open-angle glaucoma. Jpn J Ophthalmol 2016; Nov 15. [Epub ahead of print].

Ranibizumab for Vascularized Pigment Epithelial Detachment

Investigators assessed the anatomical and functional efficacy of ranibizumab on vascularized pigment epithelial detachment secondary to neovascular age-related macular degeneration.

They retrospectively selected 109 individuals (116 eyes) from the medical records of 2,097 individuals who received intravitreal injection between January 2011 and June 2013 in a tertiary-care, university-based ophthalmology department. Inclusion criteria were: nAMD; treatment-naive eyes; presence of V-PED higher than 250 μm; intravitreal ranibizumab with a loading phase, followed by a pro re nata regimen and one-year follow-up. Investigators analyzed baseline characteristics and type of choroidal neovascularization, and measured PED height, central macular thickness and best-corrected visual acuity measured at baseline, and months three, six and 12.

CNV was: type 1 in 91 eyes (78.4 percent); type 2 in seven eyes (6 percent); type 3 in six eyes (5.2 percent); and polypoidal choroidal vasculopathy in 12 eyes (10.3 percent). Mean CMT at baseline was 572.1 μm and decreased to 396.6 μm (p<0.0001) at 12 months. Mean height of PED was 458.2 μm at baseline and 306.8 μm (p<0.0001) at 12 months. Mean BCVA improved from 0.46 at baseline to 0.39 at 12 months (p=0.013).

Investigators determined that treatment with ranibizumab improved visual and anatomical outcome in nAMD patients with V-PED.

SOURCE: Chevreaud O, Oubraham H, Cohen SY, et al. Ranibizumab for vascularized pigment epithelial detachment: 1-year anatomic and functional results. Graefes Arch Clin Exp Ophthalmol 2016; Dec 3. [Epub ahead of print].

Radial Peripapillary Capillary Density in Normal Retinas Using OCTA

Scientists aimed to image the radial peripapillary capillary network with optical coherence tomography angiography and measure its capillary density in normal human retinas.

Fifty-two normal participants underwent OCTA imaging with RTVue XR 100 Avanti OCT. Scientists extracted the angioflow en face RPC network from OCTA, and selected eight peripapillary sectors with a sector angle of 45 degrees for quantitative analysis (superior nasal, superior temporal, temporal upper, temporal lower, nasal upper, nasal lower, inferior nasal and inferior temporal). They measured CD within a 3.4-mm diameter around the optic nerve head using the Bar-Selective Combination of Shifted Filter Responses method.

Using OCTA, the RPC network was visualized and revealed a pattern of parallel, long, uniform-diameter vessels around the ONH, oriented parallel to the retinal nerve fiber layer. The mean overall RPC density within the circle diameter of 3.4 mm around the ONH was 0.21 ±0.053 (CI, 0.204-0.216). The CD at the superior temporal (0.243 ±0.045) and inferior temporal (0.242 ±0.047) sectors was higher (p<0.05) when compared with the other sectors. Age, sex (p=0.7) and disc size (p=0.3) didn’t have a significant effect on CD measurement.

Scientists described a reproducible method to measure the RPC density, helping to increase the understanding of the role of the vascular bed in the RNFL’s functioning. The study demonstrated symmetry in superior and inferior corresponding pair sectors with respect to the horizontal meridian, and symmetry between paired sectors at the nasal and temporal poles with respect to the vertical meridian.

SOURCE: Mansoori T, Sivaswamy J, Gamalapati JS, et al. Measurement of radial peripapillary capillary density in the normal human retina using optical coherence tomography angiography. J Glaucoma 2016; Nov 30. [Epub ahead of print].

Incidence & Risk Factors for Developing DR Among Juvenile Type 1 & Type 2 Diabetes

Researchers sought to identify risk factors for DR in youth subjects with diabetes mellitus, to compare DR rates for juvenile type 1 diabetes mellitus (T1DM) and those with T2DM, and to assess whether adherence to DR screening guidelines promoted by the American Academy of Ophthalmology, American Academy of Pediatrics and American Diabetes Association adequately capture youths with DR.

In the retrospective observational longitudinal cohort study, researchers included subjects ages ≤21 years with newly diagnosed T1DM or T2DM who were enrolled in a large U.S. managed care network.

Researchers identified the incidence and timing of DR onset. Kaplan-Meier survival curves assessed the timing of initial diagnosis of DR, and multivariable Cox proportional hazard regression modeling identified factors associated with the hazard of developing DR. Model predictors were age and calendar year at initial diabetes mellitus diagnosis, sex, race/ethnicity, net worth and glycated hemoglobin A1c fraction. Main outcome measures included hazard ratios with confidence intervals for developing DR.

Among the 2,240 subjects with T1DM and 1,768 subjects with T2DM, 20.1 percent and 7.2 percent developed DR over a median follow-up time of 3.2 and 3.1 years, respectively. Survival curves demonstrated that children with T1DM developed DR faster than those with T2DM (p<0.0001). For every 1-point increase in HbA1c, the hazard for DR increased by 20 percent (HR=1.20; CI, 1.06-1.35) and 30 percent (HR=1.30; CI, 1.08-1.56) among cases of T1DM and T2DM, respectively. Current guidelines suggest that ophthalmic screening begin three to five years after initial diabetes mellitus diagnosis, at which point in this study >18 percent of youths with T1DM had already received ≥1 DR diagnosis.

Researchers determined that juvenile T1DM or T2DM cases exhibited a considerable risk for DR and suggested they should undergo regular screenings by eye-care professionals to ensure timely DR diagnosis and limit progression to vision-threatening disease.

SOURCE: Wang SY, Andrews CA, Herman WH, et al. Incidence and risk factors for developing diabetic retinopathy among youths with type 1 or type 2 diabetes throughout the United States. Ophthalmology 2016; Nov 30. [Epub ahead of print].



  • Coles Donate $31 Million to Cleveland Clinic Cole Eye Institute
    Jeffrey A. Cole and his wife, Patricia O’Brien Cole, awarded a transformational gift to continue their philanthropic legacy at the Cleveland Clinic Cole Eye Institute. This $31 million commitment will help Cole Eye Institute expand its clinical and surgical capabilities, and enhance its research and educational mission. This will be accomplished primarily through a future expansion to the existing Cole Eye Institute, which would be named the “Jeffrey and Patricia Cole Building.” Read more.

  • EyeGate Releases Data from Third Stage of Phase Ib/IIa Clinical Trial
    EyeGate Pharmaceuticals announced promising data from the third stage of its Phase Ib/IIa trial assessing its lead product candidate, iontophoretic EGP-437, for the treatment of ocular inflammation and pain in post-surgical cataract patients. Stage three of this multicenter, open-label clinical trial enrolled 30 subjects who underwent cataract surgery with implantation of a posterior chamber intraocular lens. Subjects were divided into three cohorts and received iontophoretic doses of EGP-437 at 4.5 milliampere-minutes, 14 mA-min or a placebo at 14 mA-min. Subjects in the EGP-437 14 mA-min cohort were administered treatments on day zero (preoperative), day one and day four. The other two cohorts were administered treatments on day 0 (postoperative), day one and day four. The potential for an additional treatment on day seven at the physician's discretion was allowed in all three cohorts. A positive response, determined by a reduction in anterior chamber cell count, was observed in cases in both of the EGP-437 treatment arms. Those who were administered 4.5 mA-min dosing (3 mA for 1.5 minutes) demonstrated the greatest benefit, with 30 percent and 80 percent of subjects at day 14 and day 28, respectively, achieving complete reduction or an ACC count of zero. Read more.

  • Aerie Completes Enrollment of Mercury 2 Phase III Registration Trial
    Aerie Pharmaceuticals completed patient enrollment in the company's second Phase III registration trial (Mercury 2) of Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, a novel, once-daily eye drop being tested for its ability to lower intraocular pressure in individuals with glaucoma or ocular hypertension. The solution is a fixed-dose combination of Aerie's drug Rhopressa (netarsudil ophthalmic solution) 0.02% and latanoprost, a widely prescribed prostaglandin analog. Total patient enrollment has exceeded the 690 individuals needed for the three-arm study designed to demonstrate superiority of Roclatan solution to each of its two components, all dosed once-daily in the evening. Read more.

  • Dr. Link Joins Allegro Board
    Allegro Ophthalmics, a biotechnology company focused on the development of novel therapies to treat vitreoretinal diseases, announced that William J. Link, PhD, was elected to Allegro's board of directors. Dr. Link is co-founder and a managing director of Versant Ventures, a global health care investment firm where he specializes in early-stage investing in medical devices. Prior to Versant, Dr. Link was a general partner at Brentwood Venture Capital. With more than two decades of operations experience in the health-care industry, Dr. Link has a proven record of building and managing large, successful medical product companies, including Chiron Vision where he was co-founder, chairman and CEO until it was sold to Bausch + Lomb in 1997. In addition, he founded and served as president of American Medical Optics. Read more.

  • AGTC Appoints Dr. Goldstein as Chief Medical Officer
    Applied Genetic Technologies Corp. announced the appointment of Michael Goldstein, MD, MBA, as chief medical officer. Prior to joining, Dr. Goldstein held roles of increasing responsibility with Eleven Biotherapeutics, including chief medical officer and vice president of clinical research, where he helped bring a novel treatment for dry-eye disease from early research to a completed trial. Since 2002, he has served as co-director of the cornea and external disease service and assistant professor of ophthalmology at the New England Eye Center. Previously, he was director of refractive surgery service and assistant professor of ophthalmology at the University of Florida College of Medicine. Read more.

  • Ruling Affirms Paragon's Patent Claim
    Paragon BioTeck announced the United States Patent and Trademark Office affirmed claims made by Paragon in the patent for its R-phenylephrine hydrochloride formulation. In late 2015, Altaire Pharmaceuticals sought to invalidate Paragon's patent that claims a method of maintaining purity of the formulation. In the fourth written decision by the Patent Trial and Appeals Board, the ruling affirmed that the petition by Altaire Pharmaceuticals was without merit. The patent ruling reinforces the science underlying the formulation of Paragon's phenylephrine hydrochloride ophthalmic solution and substantiates the operational philosophy of the company. Read more.

  • OWL Welcomes New Board Members
    OWL, an association of interdisciplinary ophthalmic professionals dedicated to driving innovation and patient care by advancing diversity in leadership, named the following new members to its board of directors.
    • Michael Ackermann, PhD, is vice president, neurostimulation at Allergan, and oversees all operations at the company’s San Francisco location. Dr. Ackermann is also co-founder of Oyster Point Pharmaceuticals, which is focused on developing novel assets for the treatment of ophthalmic disease.
    • Taryn Conway, director of marketing, Dry Eye Franchise, Allergan, leads the strategic development of dry-eye marketing, long-term strategic and life cycle management planning, and oversees implementation of key initiatives for driving continued franchise growth.
    • Candace Simerson is president of Minnesota Eye Consultants, P.A., an ophthalmology practice specializing in refractive surgery with subspecialists in cornea, glaucoma and ophthalmic plastics. In addition to more than 25 years of experience in medical practice management, Simerson is a Certified Ophthalmic Executive and a Certified Medical Practice Executive.
    • John Vukich, MD, is clinical adjunct assistant professor of ophthalmology and visual science, University of Wisconsin-Madison School of Medicine. Additionally, Dr. Vukich is president of the American-European Congress of Ophthalmic Surgery, is on the governing board for the American Society of Cataract and Refractive Surgery where he serves as chair of the Refractive Clinical Committee, and is a member of the Annual Program Committee for the American Academy of Ophthalmology.
    Read more.

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