EyeWorld Weekly Update, December 23, 2016

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December 23, 2016
Volume 21 , Number 48

Episcleral brachytherapy device granted 510(k) clearance

The SMD-Sr90-DA Radionuclide Brachytherapy Source (RBS), intended for use within a manual brachytherapy applicator system and indicated for episcleral brachytherapy, has received U.S. regulatory clearance, developer Salutaris Medical Devices (Tucson, Arizona) said in a press release. The device is designed to be performed in an outpatient setting in about 15 minutes, the company said; the technology delivers a single-use brachytherapy procedure.

3-D printers help develop strabismus medical instruments

Donny Suh, MD, and colleagues in a university printing club are using 3-D technology to develop new instruments for use in strabismus surgery, the University of Nebraska Medical Center (Omaha) said in a press release. Because needle drivers cannot easily maneuver in pediatric eyes, Dr. Suh developed a new instrument to overcome the challenge, and used 3-D technology to develop a prototype to be tried in a laboratory setting. When the prototype is completed, Dr. Suh will first test the tool in the laboratory, and plans to present the project next year during major ophthalmic conferences.

EYE 102 study now complete, shows positive results

A Phase 2 study evaluating the safety and efficacy of a topical piezo-print microtherapeutic approach for ophthalmic mydriasis has positive results, developer Eyenovia (New York) said in a press release. The EYE 102 study demonstrates that Eyenovia's proprietary microtherapeutic approach can reduce ocular side effects with an 8% rate of ocular adverse events versus 66% for conventional topical treatment. Further, high-precision piezo-formulated microdosing demonstrates superior pharmacologic effect and bioavailability over dose-equivalent dropper therapy, the company said.

Novartis buys Encore Vision

Novartis (Basel, Switzerland) will buy Encore Vision (Fort Worth, Texas), which is developing a first-in-class disease modifying topical treatment for presbyopia, the companies announced. Encore Vision's lead investigational product, EV06, has successfully completed Phase 1/2 masked, placebo-controlled proof-of-concept studies. In those, 50 patients were treated daily for 90 days with topical EV06 and 25 patients with placebo. EV06 showed a statistically significant difference to placebo in distant corrected near vision at all time points measured (from day 8); at day 90, 82% of participants treated with EV06 had 20/40 near vision (or 0.30 LogMAR) versus 48% in the placebo group.

Cornea Society awards Jonathan Lass, MD, its Castroviejo Medal

The Cornea Society awarded Jonathan Lass, MD, the Castroviejo Medal, its highest honor, University Hospitals Cleveland Medical Center (Ohio) said in a press release. Dr. Lass, an ophthalmologist at University Hospitals Eye Institute at UH Cleveland Medical Center and Charles I Thomas Professor of Ophthalmology at Case Western Reserve University School of Medicine, has received the award in recognition of his lifetime contributions to research and advancements in corneal transplant and surgery. Among his accomplishments, Dr. Lass has standardized the way corneal specialists review specular microscopy through the development of the Cornea Image Analysis Reading Center and as a result improved clinicians' evaluation of corneal endothelial cells. He was also paramount in the success of the Cornea Donor Study and the Cornea Preservation Time Study.

RESEARCH BRIEFS

  • Glucosamine supplement therapy causes a statistically significant rise of IOP, which is more pronounced in elderly patients, according to a study. H. Esfandiari and colleagues randomized 88 patients with osteoarthritis to either glucosamine sulfate or placebo (n=44 each). The mean IOP at the time of presentation was 12.4±2.7 mm Hg in glucosamine and 13±2.8 mm Hg in the placebo group (P=0.329). At month 1 the corresponding values were 12.6±2.4 and 12.9±2.4 mm Hg (P=0.868), and at 3 months of follow-up were 13.5±2.3 and 13±2.7 mm Hg (P=0.002), respectively. About 34.1% in treatment and 12.5% in the placebo group had a clinically significant (defined as ≥ 2 mm Hg) rise in IOP at final follow-up (P=0.023). Mean age in those with significant rise in IOP was 66 vs. 57.7 years in patients with <2 mm Hg (P=0.034). The ocular response analyzer parameters remained unchanged in both the groups during the course of study. The study is published online ahead of print in Eye (London)
  • Visual acuity outcomes at 12 months did not differ between ranibizumab and aflibercept when used for the treatment of neovascular age-related macular degeneration (nAMD) in a large observational study, nor was a difference in treatment frequency found, according to Mark Gillies, MBBS, and colleagues. Treatment-naïve eyes with nAMD were tracked by the Fight Retinal Blindness outcome registry that commenced antivascular endothelial growth factor therapy with ranibizumab (n=197) or aflibercept (n=197) between December 1, 2013, and January 31, 2015. Eyes were matched at baseline for visual acuity (VA), age, and choroidal neovascular membrane (CNV) size. Baseline parameters were well matched. The mean (standard deviation) VA of ranibizumab-treated eyes increased from 58.6 (20.3) letters at baseline to 62.3 (23.9) letters (P=0.001), compared with 58.9 (19.2) letters at baseline to 63.1 (21.5) letters (P<0.001) for eyes receiving aflibercept. The difference in change in crude VA of 0.6 letters between the two groups was not statistically significant (P=0.76), nor was the difference in adjusted mean VA of the two groups (P=0.26). In completers, the mean (SD) numbers of injections (8.1 [2.1] vs. 8.0 [2.3]; P=0.27) and visits (9.6 [3.0] vs. 9.5 [3.1]; P=0.15) did not differ between the two groups. The adjusted proportion of eyes in which the CNV lesion was graded as inactive during the study was similar between the eyes receiving ranibizumab and aflibercept (74% vs. 77%, respectively; P=0.63). The study is published in Ophthalmology. 
  • Intracameral moxifloxacin prepared by dilution of 3 cc moxifloxacin 0.5% with 7 cc balanced salt solution and with the administration of 0.3 to 0.4 cc (450 to 600 mcg) as the final step in cataract surgery via the side port after the main incision has been sealed and hydrated showed advantages over alternative intracameral antibiotic prophylactic methods, with minimum risk, according to Steve Arshinoff, MD, and Milad Madabber, MD. In their retrospective evaluation, a single infection in 3,430 cases occurred with a moxifloxacin-resistant strain of Staphylococcus epidermidis when moxifloxacin 100 mcg in 0.1 mL was used. Increasing the dose and changing the administration technique resulted in no infections in 4,601 cases and no detrimental side effects or complications. The study is published in the Journal of Cataract & Refractive Surgery.

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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