EyeWorld Weekly Update, August 4, 2017

2017-08-04

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August 4, 2017
Volume 23 , Number 27

Johnson & Johnson Vision to acquire TearScience

Johnson & Johnson Vision (Santa Ana, California) announced a definitive agreement to acquire TearScience (Morrisville, North Carolina), a medical device manufacturer dedicated to evaluating meibomian gland health and treating meibomian gland dysfunction (MGD). TearScience received FDA clearance for an office-based approach to image meibomian glands and treat MGD. Johnson & Johnson Vision will acquire TearScience through its surgical vision operating company, Abbott Medical Optics. The transaction is expected to close by the end of the year.

First patient enrolled in Phase 2b study for EGP-437 use with cataract surgery

The first patient was enrolled this month in a Phase 2b clinical trial for the EGP-437 combination product from EyeGate Pharmaceuticals (Waltham, Massachusetts). It combines the EyeGate II Delivery System and EPG-437 combination product to treat pain and inflammation from cataract surgery with implantation of a monofocal posterior chamber IOL. The Phase 2b study is a double-masked, randomized, placebo-controlled trial that is planned to enroll up to 100 patients at eight sites throughout the U.S. The goal is to evaluate the safety and efficacy of iontophoretically delivered EGP-437 through the EyeGate II Delivery System. The primary efficacy endpoint will be the proportion of subjects with an anterior chamber cell count of zero at day 7 and the proportion of subjects at day 1 with a pain score of zero.

Updated Dry Eye Workshop report available from the Tear Film Society

An updated definition of dry eye has been created by the clinical and basic research experts who participated in the Tear Film and Ocular Surface Society's Dry Eye Workshop II (DEWS II). They focused on an evidence-based approach with open communication and dialogue to achieve a global consensus of dry eye disease. The DEWS II report, published in the journal The Ocular Surface, is the sequel to the original report from 2007. The new definition describes dry eye as a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film. The definition also refers to tear film instability and hyperosmolarity as well as ocular surface inflammation and damage and neurosensory abnormalities that all play roles in causing the disease. The new information from DEWS II addresses other aspects of dry eye, including epidemiology, management, and recommendations for the design of clinical trials. Translations of DEWS II will be available in multiple languages.

Iris freckles could indicate chronic sun exposure Iris freckles could indicate chronic sun exposure

The presence of iris freckles could be one of a handful of factors that indicate chronic sun exposure in patients, reported Christoph Schwab, and co-researchers. The researchers prospectively examined 632 volunteers at a skin cancer screening program. About 76% of individuals had at least one iris freckle, mostly in the inferior temporal quadrant. Several factors were associated with the presence of iris freckles, including a higher age, a high number of sunburns over time, sunlight-damaged skin, the presence of actinic lentigines, and a high total nevus body count. "The evaluation of iris freckles offers an easily accessible potential biomarker, which might be helpful in indicating sun damage on the skin associated with cutaneous malignancies," the authors concluded. The research appears in Investigative Ophthalmology & Visual Sciences.

Enrollment completed in Phase 3 study of GS010 for Leber's hereditary optic neuropathy

Enrollment in the RESCUE Phase 3 trial of GS010 (GenSight Biologics, Paris, France) for Leber's hereditary optic neuropathy has been completed, according to a company press release. RESCUE is one of two parallel randomized multicenter trials underway to evaluate the efficacy of a single intravitreal injection of GS010 (rAAV2/2-ND4) in subjects affected by Leber's due to the G11778A mutation in the mitochondrial ND4 gene. The trial has enrolled 37 patients with a vision loss onset of less than 6 months. The second trial, REVERSE, completed enrollment in February of this year and includes 36 patients with a vision loss onset of 7 to 12 months. Results from these trials are expected in the first half of 2018, GenSight reported. GS010 has Orphan Drug Designation in the U.S. and Europe.

RESEARCH BRIEFS

  • About half of people with non-proliferative or proliferative diabetic retinopathy (NPDR/PDR) had trouble with at least one visual function task, according to Jeffrey Willis, MD, and co-researchers. The researchers completed a cross-sectional analysis of 1,004 people in the National Health and Nutrition Examination Survey 2005-2008 who had diabetes and valid ocular and sociodemographic outcomes. They defined functional difficulties as self-reported difficulty with reading, visuospatial tasks (such as close-up work or finding things on a crowded shelf), mobility, and driving. Among patients, 72.3% had no retinopathy, 25.4% had mild and moderate NPDR, and 2.3% had severe NPDR or PDR. The prevalence of vision-related functional burden was 20.2% in those with no neuropathy, 20.4% in those with mild and moderate disease, and 48.5% in those with severe NPDR or PDR. They found that vision-related functional burden was worse in those with severe NPDR or PDR compared with those who did not have retinopathy. The study appears in JAMA Ophthalmology.
  • More than 16 million U.S. adults, or 6.8% of the U.S. adult population, have diagnosed dry eye disease, according to Kimberly Farrand and co-researchers. This number is an estimate in their cross-sectional, population-based survey that analyzed 75,000 participants in the 2013 National Health and Wellness Survey. The observed dry eye disease prevalence was weighted to project estimates among the adult population and associated risk factors. Prevalence increased with age and was more common in women. The risk for diagnosis was higher among those aged 45 to 54 years old. Dry eye disease was also more commonly diagnosed in those with insurance versus uninsured participants. The research is published in the American Journal of Ophthalmology.
  • During a 5-year period, the risk for surgery decreased, although the number of secondary IOL procedures increased in a population-based retrospective study that focused on incidence and trends in IOL repositioning, exchange, and explantation. Led by Andrei-Alexandru Szigiato, MD, researchers reviewed service claims from 2000 to 2013 for annual IOL repositionings, exchanges, and explantations in Ontario, Canada. There were 1,252 secondary procedures in 2013, a 75.6% increase compared with 2000. Of these, 43.2% were repositionings without suturing, 31.6% were exchanges without suturing, 10.5% were sutured repositionings, 7% were sutured exchanges, and 7.7% were explantations. From 2000 to 2004, the incidence proportion of risk for secondary IOL surgery was 0.93%. That compared with 0.78% from 2009 to 2013. Sutured repositionings and explantations increased by 568% and 531%, respectively, from 2000 to 2013. The research is published in the Journal of Cataract & Refractive Surgery.
  • A weekly or biweekly dose of tocilizumab (Actemra, Roche, Basel, Switzerland) combined with a 26-week prednisone taper was more effective than a 26-week or 52-week prednisone taper plus placebo for sustained glucocorticoid-free remission in patients with giant cell arteritis, according to John Stone, MD, and co-researchers. Their 1-year trial randomly assigned 251 patients to the various treatment groups. In patients with tocilizumab 162 mg received weekly, 56% achieved sustained remission at week 52. This compared with 53% of those treated with tocilizumab biweekly, 14% of those in the placebo group with the 26-week prednisone taper, and 18% of those in the placebo group with the 52-week prednisone taper. The percentage of serious adverse events was 15% in the tocilizumab weekly group, 14% in the biweekly tocilizumab group, 22% in the placebo group with the 26-week taper, and 25% in the placebo group that had a 52-week taper. Longer follow-up is needed, the researchers noted. Actemra was approved by the U.S. Food and Drug Administration (FDA) for giant cell arteritis in May. The study appears in the New England Journal of Medicine.

PRODUCT NEWS

  • The Easyret fully integrated 577 nm yellow photocoagulator (Quantel, Clermont-Ferrand, France) has been approved by the FDA to treat certain forms of macular edema and peripheral retinal pathologies.

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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