EyeWorld Weekly Update, October 6, 2017

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October 6, 2017
Volume 23 , Number 35

Antitrust suit filed by Shire against Allergan over rival dry eye drops

Shire Pharmaceuticals (Lexington, Massachusetts) filed an antitrust suit against Allergan (Dublin, Ireland), alleging that Allergan's contracts with drug plans for Medicare Part D for Restasis eye drops (cyclosporine) blocked access to Shire's newer Xiidra (lifitegrast). In the complaint, Shire said that although it offered discounts in bids to secure coverage of Xiidra, Part D plans refused due to what it said were Allergan's "bundled discounts" and "exclusive dealing," among other tactics. The suit also alleges that Allergan "compelled and coerced" Part D plans to limit Xiidra access with discounts on Restasis and glaucoma drugs from Allergan. About 13% of Part D patients have access to Xiidra on their drug formularies compared with 88% of commercially insured patients, a Shire spokeswoman was quoted as saying in a Wall Street Journal article. The suit was filed in a federal court in Trenton, New Jersey.

ASCRS and ophthalmic community to sponsor Ophthalmic Digital Health workshop

The ASCRS is partnering with the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health, the American Academy of Ophthalmology, the American Academy of Pediatrics, the American Association for Pediatric Ophthalmology and Strabismus, the American Society of Retina Specialists, and Stanford Medicine, Byers Eye Institute to sponsor a 1-day workshop titled "Ophthalmic Digital Health." The workshop will bring together healthcare practitioners, researchers, medical device firms, mobile application developers, patients, and other stakeholders to address factors in evaluating and improving the safety and effectiveness of ophthalmic digital health devices. Guest speakers include FDA Commissioner Scott Gottlieb, MD, and the FDA Center for Devices and Radiological Health Director Jeff Shuren, MD, JD. The workshop is scheduled for Monday, October 23, from 7:45 a.m.-5:00 p.m. at the Holiday Inn Gaithersburg. The workshop will also be available as a live webcast. Registration closes on Tuesday, October 17. Everyone must register on the website prior to the deadline in order to attend in person or online. No registration will be available at or on the day of the event. For more information and to register, visit cfom.info/OphthDigitalHealth.

Blood biomarkers may help identify patients with age-related macular degeneration

In a cross-sectional observational study, patients with age-related macular degeneration (AMD) were found to have altered plasma metabolomic profiles compared with control patients, according to Iňes Lains, MD, and coauthors. All patients had color fundus photography and fasting blood samples as well as plasma analysis using ultra high performance liquid chromatography and high resolution mass spectrometry. Ninety participants with various stages of AMD were included along with 30 controls. The tests identified 878 biochemicals; multivariate logistic regression identified 87 metabolites with levels that had a significant difference between AMD patients and controls. Nearly 83% of the metabolites belonged to the lipid pathways. Of the 87 metabolites, 55.2% were significantly different across AMD stages. The findings could help improve an understanding of AMD pathogenesis and support the development of plasma-based metabolomics biomarkers, the researchers concluded. The study is published in Ophthalmology.

RESEARCH BRIEFS

  • Vitrectomy achieved excellent anatomical outcomes and improved or stabilized vision in 80.1% of eyes in a large, single-center retrospective study focused on visual and anatomical outcomes of diabetic tractional retinal detachment repaired with pars plana vitrectomy. Led by Philip Storey, MD, researchers used operative records to identify all patients with tractional retinal detachments secondary to proliferative diabetic retinopathy surgically repaired with pars plana vitrectomy over a 6-year period. A total of 403 eyes (359 patients) were included. In 87.6% of eyes, successful retina reattachment occurred after one surgery; successful reattachment occurred in 92.6% of eyes at the final follow-up. At the final follow-up, best corrected visual acuity (BCVA) had improved two or more lines in 56.3% of eyes. The BCVA was stable in 23.8% of eyes and had decreased two or more lines in 19.9% of eyes. There were similar success rates with 20-gauge, 23-gauge, and 25-gauge instrumentation. Eyes that received silicone oil tamponade had lower single-surgery reattachment rates, lower reattachment rates at the final follow-up, and higher rates of vision loss. However, these same eyes were more likely to have concurrent rhegmatogenous detachment. The study appears in Retina.
  • A study focusing on whether eyebank-processed endothelial keratoplasty tissue is at a higher risk of contamination than unprocessed tissue found that in donor rim cultures, detectable Candida growth was seen and was associated with a higher rate of post-keratoplasty infection. Led by Kimberly Brothers, PhD, researchers studied 6,592 corneal transplants. Donor rim culture results were three times more likely to test positive for fungi in endothelial keratoplasty-processed eyes (1.14%) compared with other uses (0.37%). An increased room temperature incubation of Optisol-GS (Bausch + Lomb, Bridgewater, New Jersey) increased growth of Candida species over time in vitro. However, the addition of caspofungin and voriconazole decreased Candida growth in a species-dependent manner. The study is published in JAMA Ophthalmology.
  • A prospective study focused on the use of two portable cameras to detect corneal disease found that sensitivity values are not yet suitable for telemedicine applications. Led by Maria Woodward, MD, a corneal specialist provided a gold standard diagnosis via slit lamp examination. Eye images using two cameras in multiple gazes were obtained and interpreted by three corneal specialists for the presence of pathology. There were 198 eyes (110 subjects) that were photographed. Using gold standard diagnosis, 30% had corneal scars, 17% had ulcers, 7% had abrasions, 5% had pterygia, and 41% were normal. Sensitivity to detect anterior segment pathology ranged from 54% to 71% for the iTouch (Apple, Cupertino, California) and 66% to 75% for the Nidek (Tokyo, Japan). Specificity was 82% to 96% for the iTouch and 91% to 98% for the Nidek. Additional work is required to improve the ability to detect anterior segment pathology remotely, the researchers concluded. The study appears in Cornea.
  • Cataract surgery was performed successfully with no long-term complications in a small series of patients with late-onset retinal degeneration, according to Vasileios Papastavrou, MD, and co-researchers. Their work reviewed outcomes in 11 eyes (seven patients) with long anterior lens zonular fibers associated with late-onset retinal degeneration who had phacoemulsification cataract surgery. Although long anterior lens zonular fibers made capsulorhexis more challenging, it was completed safely. No lens stability issues occurred. The corrected distance visual acuity (CDVA) improved postoperatively in cases with intact foveal photoreceptors and retinal pigment epithelium. However, the CDVA slowly declined over the long term due to progressive atrophy of the macula. Most patients noticed a subjective improvement in vision. The research appears in the Journal of Cataract & Refractive Surgery.
PRODUCT NEWS
  • IOPtima (Tel Aviv, Israel) launched a microemulsion called LIPITEAR. LIPITEAR is formed by an aqueous phase and a lipidic phase to help restore the microenvironment of the ocular surface. It helps to enhance the physiological process of corneal re-epithelialization after ocular surgery while reducing the typical symptoms and signs of ocular surface disease.
  • The HD Analyzer (Visiometrics, Costa Mesa, California) now has a Touch Screen Package. The new upgrade option increases ease of use and reduces the system footprint for better practice workflow, according to a company press release.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (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; Reay Brown, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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