EyeWorld Weekly Update, May 25, 2018

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May 25, 2018
Volume 24 , Number 18

FDA seeks permanent injunctions against two stem cell clinics

The U.S. Food and Drug Administration (FDA) announced that it is seeking permanent injunctions to halt two stem cell clinics from marketing stem cell products without FDA approval. One clinic is U.S. Stem Cell Clinic LLC of Sunrise, Florida, which did not address violations outlined in a warning letter to the clinic in August 2017 and failed to come into compliance with the law. Both the clinic and chief scientific officer Kristin Comella and co-owner/managing officer Theodore Gradel are named in the injunction. The second clinic is California Stem Cell Treatment Center in Rancho Mirage and Beverly Hills, California, along with Cell Surgical Network Corporation of Rancho Mirage and Elliot Lander, MD, and Mark Berman, MD, who control the operations of about 100 for-profit affiliate clinics. Both clinics have been asked to stop marketing their stem cell products until they obtain needed FDA approvals and correct violations of current good manufacturing practice requirements. A report in the New England Journal of Medicine last year shared that three patients who received stem cell eye injections for age-related macular degeneration at U.S. Stem Cell Clinic were blinded after the injections. The experimental treatments involved stem cells derived from the patients' own abdominal fat.

Study pinpoints genes that may predict risk for glaucoma

A meta-analysis led by A.P. Khawaja of 139,555 participants in the European Union identified 112 genomic loci associated with IOP. The IOP of each patient was compared with each individual's DNA analysis to measure how likely it was that they would develop glaucoma, according to a press release about the study. The genetic variations helped predict with 75% accuracy who might develop glaucoma. Sixty-eight of the genetic variants were newly identified. "These loci suggest a strong role for angiopoietin-receptor tyrosine kinase signaling, lipid metabolism, mitochondrial function, and developmental processes underlying risk for elevated IOP," the researchers wrote. In an independent cohort, 48 of the loci were nominally associated with glaucoma, 14 of which were significant at a Bonferroni-corrected threshold. Models of genetic prediction for primary open angle glaucoma offer the chance to target screening and offer therapy to at-risk individuals, the researchers concluded. The study appears in Nature Genetics.

EyeGate addresses action items from the FDA regarding Ocular Bandage Gel

EyeGate Pharmaceuticals (Waltham, Massachusetts) has addressed three of four outstanding items in response to the FDA's queries regarding its Ocular Bandage Gel (OBG). In an amendment response letter, the FDA pointed out four insufficiencies in the company's Investigational Device Exemption (IDE) submission and requested additional information on the manufacturing processes associated with the product. Clarifications of questions on data and documentation changes have been addressed by the company; work continues on a request for validation of a filter used in the sterilization process, the company reported in a press release. This final concern should be addressed by the end of second quarter 2018, according to the company. The OBG is a crosslinked thiolated carboxymethyl hyaluronic acid platform under development for the re-epithelialization of large corneal epithelial defects in patients who have had PRK.

Register for the 2018 Combined Ophthalmic Symposium

Register today for the 2018 Combined Ophthalmic Symposium, August 24-26 in Austin, Texas at the JW Marriott.
The Combined Ophthalmic Symposium provides education for the entire ophthalmic practice in one weekend. The Ophthalmologist Program will be held August 25, from 8:00 a.m.-5:30 p.m. and August 26, from 8:00 a.m.-12:30 p.m. The 2018 program chairs are Douglas Koch, MD, Sumitra Khandelwal, MD, and Douglas Rhee, MD. They'll be joined by an esteemed faculty who'll deliver the high quality educational programming for which ASCRS is recognized.
The program will address multiple relevant and timely topics in ophthalmology, including:
  • Cataract Surgery: Upping Your Game
  • Premium Cataract Surgery: Setting and Meeting Expectations
  • Glaucoma: The Pressure is On!
  • Video Session: Was that a Good Idea?
  • Cornea Controversies
  • Refractive Surgery Pearls for the Comprehensive Ophthalmologist
  • Ocular Surface Management: Polishing the Mirror
  • What Am I Doing NEW in 2018? The Future of Ophthalmology

RESEARCH BRIEFS

  • Eye trauma, although decreasing, remains more common in summer months, according to David Ramirez and coresearchers in their retrospective, cross-sectional study. They used the Nationwide Emergency Department Sample of emergency department (ED) visits in the U.S. and its billing codes from 2006 to 2013 to identify all cases of ocular trauma as well as the U.S. decennial census to estimate the population at risk for visiting an ED. Main outcomes measured were seasonal and annual trends in ED-diagnosed eye trauma. During the 8-year study period, there were 5,615,532 ED encounters for eye trauma, of which 66% were male and under 60 years of age (91%). Superficial eye injury and adnexa, contusion of the eye and adnexa, and ocular adnexal open wound were the most common ocular trauma presentations. There was a mean annual peak between May and July for ocular trauma visits. However, eye trauma visits decreased by a mean of 4% per year over the study period. Prevention efforts in the spring or summer months would be most effective, the researchers concluded. The study is published in the American Journal of Ophthalmology.
  • Low-density lipoprotein cholesterol (LDL-C) and triglyceride levels were found to be independent risk factors for age-related cataract in a cross-sectional, case-control study, according to Li Shengjie and coresearchers. The study included 219 age-related cataract subjects and 218 normal control subjects. Serum high-density lipoprotein cholesterol, LDL-C, triglyceride, cholesterol, serum apolipoprotein A (APOA) and apolipoprotein B (APOB) levels were measured, and a detailed eye and systematic examination was performed. Serum LDL-C, triglyceride, cholesterol, and APOA levels were markedly higher (P<0.05) in the age-related cataract group compared with the control group. A similar result was seen when serum lipid concentrations were compared between the age-related cataract and the control groups. The study is published in BMJ Open.
  • Cataract surgery was successful in eyes that had deep anterior lamellar keratoplasty (DALK) or penetrating keratoplasty (PKP), according to a retrospective case series led by Seika Den, MD. Researchers analyzed age-matched and disease-matched eyes that had phaco and IOL insertion after DALK or PKP. Keratoplasty indications included corneal stromal scar (22 eyes), lattice dystrophy (two eyes), keratoconus (two eyes), and postherpetic keratitis (four eyes). Cataract surgery was successful after keratoplasty in all 30 eyes, and graft clarity rates were 90% and 80% in the DALK and PKP groups. There was a significantly greater decrease in endothelial cell density at 12 months in the PKP group compared with the DALK group. The corrected distance visual acuity significantly increased in each group, and there was a mean refractive error at 1 month of -0.5 D in the DALK group and -0.4 D in the PKP group. The refractive error remained stable thereafter. "In cases of combined cataract and corneal pathology, and in the absence of endothelial involvement, DALK followed by cataract surgery might cause less endothelial damage," the authors concluded. The research appears in the Journal of Cataract & Refractive Surgery.

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; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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