EW Weekly, June 3, 2016

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June 3, 2016
Volume 21 , Number 19

In memoriam: Peter Barry, MD

Peter Barry, MD, passed away on May 26 after a short illness. Dr. Barry was a founding member of the European Society of Cataract & Refractive Surgeons (ESCRS), and served as its treasurer, president, and director. "He was a person of great vision who made an immense contribution not only to the success of the ESCRS but to the wider world of ophthalmology," ESCRS said in a statement. "All of ophthalmology lost a colleague, leader, and dear friend with the passing of Peter Barry," said Eric Donnenfeld, MD, EyeWorld chief medical editor. "Peter was a larger-than-life individual who was instrumental in founding ESCRS and was a guiding light in navigating the close relationship between his organization and ASCRS. His seminal work on intracameral antibiotics has had a worldwide impact on the way we perform cataract surgery. ASCRS and EyeWorld will miss Peter Barry, the curmudgeon who endeared himself to everyone he touched." 

Iontophoretic EGP-437 generates "positive response" in early study

Data from a phase 1b/2a trial evaluating iontophoretic EGP-437 (dexamethasone phosphate) in the treatment of ocular inflammation and pain in cataract surgery patients has shown positive interim results, developer EyeGate Pharmaceuticals (Waltham, Massachusetts) said in a press release, with a majority of patients presenting with an anterior chamber clearance (ACC) of zero at day 14. The multicenter, open-label trial planned to enroll up to 50 subjects who have undergone unilateral cataract extraction and implantation of a monofocal IOL to assess the safety and efficacy of iontophoretic EGP-437 post-surgery. There are 5 planned cohorts with iontophoretic doses of 4.0 mA-min, 9.0 mA-min and 14.0 mA-min employed, and the 9.0 and 14.0 mA-min cohorts included 2 different dosing regimens. Subjects in the 9.0 and 14.0 mA-min cohorts had 3 treatments administered on day 0, day 1, and day 2 or day 0, day 1, and day 4 with potential for an additional treatment at day 7 in all cohorts. The primary endpoint for all cohorts is ACC at day 14, with secondary endpoints measuring pain score and intraocular pressure. Interim results show some patients in the 9.0 and 14.0 mA-min cohorts presented with ACC of zero at day 14 and others presented with trace ACC levels. Additionally, all subjects experienced low pain throughout the duration of the trial. EGP-437 incorporates dexamethasone into the EyeGate II Delivery System that uses iontophoresis to migrate the charged drug substance across biological membranes.

U.K. authorities give OK to bionic vision system study

The United Kingdom's Medicines & Healthcare products Regulatory Agency approved a clinical study for the 150 electrode IRIS II bionic vision system for patients who have lost sight due to retinitis pigmentosa, developer Pixium Vision (Paris) said in a news release. Moorfields Eye Hospital (London) will evaluate a mini bio-inspired camera and a 150 electrode epi-retinal implant with an explantable design. The IRIS II is under review for a CE mark, and Pixium plans to commercialize the device in the second half of 2016 if approved. The IRIS II clinical trial is a multicenter, open label, non-randomized prospective European study that will enroll up to 10 patients with retinitis pigmentosa, Usher syndrome, cone-rod dystrophy, or choroideremia who will be followed for a minimum of 18 months, with additional 18-month follow-up, Pixium said.

Presbia close to filing its Flexivue Microlens

All 421 subjects treated with the Flexivue Microlens (Presbia, Dublin) have completed their 6-month postop visits as part of the company's Food and Drug Administration pivotal study, Presbia noted in a press release. The company expects to submit its final premarket approval module in about 18 months (targeting Q4 2017), once 300 of the 421 subjects complete their 24-month postoperative visits.

RESEARCH BRIEFS

  • Umbilical cord serum drops (UCS) and amniotic membrane transplantation (AMT), as an adjuvant to standard medical therapy in acute chemical injury, are equally efficacious, according to a new study. N. Sharma and colleagues evaluated 45 eyes with acute chemical burns of grade III, IV, and V (Dua's classification) presenting within the first week of injury. They were randomized into 3 groups (15 each): UCS with medical therapy (MT), AMT with MT, and MT alone respectively. Patients with perforation/impending corneal perforation were excluded from the study. The mean time to complete epithelialization was 56.7±14.9, 22.0±10.2, and 22.9±10.1 days in the MT, AMT, and UCS groups, respectively, with a significant difference between MT and AMT (P=0.001), between MT and UCS (P=0.001), but not between UCS and AMT (P=0.9). Improvement in pain score was better with UCS than AMT (p value; 0.012, 0.002, and 0.012 on day 7, 14, and 21, respectively). Corneal clarity was better in the UCS group at 21 (P=0.008) and 30 days (P=0.002), but not at 3 months (P=0.9). By month 3, visual outcome, symblepharon, tear film status, and lid abnormalities were comparable between the 3 groups. The study is published in the American Journal of Ophthalmology.
  • Eyes with successful IOP reduction, a limbus-based conjunctival flap, lower preoperative IOP, and choroidal detachment that occurred within 6 months of the surgery were identified as risk factors for persistent hypotony, according to T. Higashide and colleagues. In the Collaborative Bleb-Related Infection Incidence and Treatment Study, a 5-year prospective multicenter study, the researchers evaluated 955 eyes of 955 patients who underwent trabeculectomy with mitomycin-C. Surgical failure was defined as insufficient IOP reduction (IOP>21 mm Hg or <20% IOP reduction, or further glaucoma surgeries), loss of light perception, or persistent hypotony (IOP ≤5 mm Hg persisting for >6 months). The cumulative probabilities of surgical success and persistent hypotony at 5 years were 62.0±1.7% and 7.7±0.9%, respectively. In 685 eyes with sufficient IOP reduction, preoperative IOP (mm Hg), limbus-based conjunctival flap, or choroidal detachment that occurred within 6 months of the surgery were significant risk factors for persistent hypotony. Bleb infection and final visual acuity were significantly associated with persistent hypotony. The study is published in the Japanese Journal of Ophthalmology.
  • An increase in hyperopia occurs after hyperopic LASIK according to results from a 16-year study, but no sight-threatening complications occurred. Reena Dave and colleagues performed hyperopic LASIK using a mechanical microkeratome, an optical zone of 6.5 mm, and a blend zone of 1.5 mm in their prospective cohort study. The mean patient age was 51.6 years (range 34 to 60 years). Preoperatively, the mean spherical equivalent (SE) was +3.74 D (range +1.25 to +6.50 D). The mean attempted correction was +3.64 D. The mean SE was +0.28 D at 12 months, +0.84 D at 5 years, and +1.74 D at 16 years, representing an increase in hyperopia of +1.47±1.43 D between 1 year and 16 years (P<.0001). The uncorrected distance visual acuity improved at 16 years (P<.0001); corrected distance visual acuity (CDVA) was unchanged. The efficacy index was 0.5 and the safety index, 1.09. The study is published in the Journal of Cataract & Refractive Surgery.

NEW PRODUCT BRIEFS

  • Bausch + Lomb (Bridgewater, New Jersey) launched a small gauge vitrectomy package for the Stellaris microsurgical system that combines essential components for 23-gauge and 25-gauge anterior vitrectomy. This allows surgeons to perform anterior vitrectomy at their own preferred incision size either anteriorly through a corneal incision or using a pars plana approach with the respective ESA cannula.
  • Optovue (Fremont, California) introduced the AngioVue Retina, a "proprietary imaging system that provides retina specialists with a non-invasive, dyeless way to quickly visualize blood flow in the retina." AngioVue Retina is configured with essential optical coherence tomography (OCT) and OCT angiography features designed specifically for retinal practices.

EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Eric Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara Chan, MD, cornea editor; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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