EW Weekly, June 17, 2016

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June 17, 2016
Volume 21 , Number 21

XEN45 Gel Stent filing accepted by FDA

The XEN Glaucoma Treatment System (consisting of the XEN45 Gel Stent and the XEN Injector) has been accepted for filing by the U.S. Food and Drug Administration, Allergan (Dublin) said in a press release. The XEN45 is a minimally invasive implantable crosslinked gelatin shunt designed to reduce IOP associated with refractory glaucoma. The device already has the CE mark in Europe, and is licensed for use in Canada, Switzerland, and Turkey.

University of Houston researchers pursuing hi-res corneal imaging

University of Houston researchers are developing new techniques to map the structural integrity of the human cornea, using a $1.7 million grant from the National Institutes of Health, the university said in a press release. Kirill Larin, professor of biomedical engineering and director of the Biomedical Optics Laboratory, University of Houston Cullen College of Engineering, has developed the technique that uses high-resolution imaging and mechanical mapping of the cornea and can gauge the structural integrity of corneal tissue. The emerging field, known as optical elastography, involves optical imaging and analysis of tissue response to deformation, the university said in its release. Optical elastography involves using a light puff of air to capture very small changes in the cornea's structure, Mr. Larin said (changes measured in micrometers, rather than millimeters) to reconstruct the mechanical properties of the cornea in 3D. Potential uses in refractive surgery include use in developing personalized therapies for people with keratoconus, including determining the optimal duration of treatment, and to test for early stage corneal degeneration before performing myopic LASIK surgery, Mr. Larin said.

NEI: Less DR progression with intensive glycemic control

People with type 2 diabetes who intensively controlled their blood sugar level during the landmark Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial were found to have cut their risk of diabetic retinopathy (DR) in half in a follow-up analysis conducted 4 years after stopping intensive therapy, according to the National Eye Institute (NEI, Washington, D.C.). Investigators who led the ACCORD Follow-On Eye Study (ACCORDION) presented their results at this week's American Diabetes Association meeting. "Well-controlled glycemia, or blood sugar level, has a positive, measurable, and lasting effect on eye health. The study sends a powerful message to people with type 2 diabetes who worry about losing vision," said Emily Chew, MD, deputy director, NEI Division of Epidemiology and Clinical Applications. ACCORDION is a follow-up assessment of DR progression in 1,310 people who participated in ACCORD, which tested 3 treatment strategies to reduce the risk of cardiovascular disease among people with longstanding type 2 diabetes. The treatment phase of the glycemic control portion of ACCORD had been planned to last 5.6 years but was stopped at 3.5 years due to an increase in death among participants in the intensive glycemic control group. While ACCORD did not reduce cardiovascular disease risk, it did cut DR progression by about 33% at the end of the study.

Genetic cause of primary congenital glaucoma identified

Researchers at 2 universities have identified a gene that causes primary congenital glaucoma, the universities announced. Researchers at Northwestern Medicine and University of Wisconsin-Madison first discovered the genetic mutation in mice 2 years ago. The TEK gene is involved in the development of Schlemm's canal. The researchers previously showed that deleting the gene in mouse models led to glaucoma. Altogether, the teams found TEK mutations in 10 unrelated families with children who have primary congenital glaucoma. None of the children had mutations in other genes known to cause glaucoma. The scientists then demonstrated that the TEK mutations identified in children impair the vascular signaling pathway important in Schlemm's canal formation. The group is developing an eye drop to repair the TEK pathway.

Otsuka terminates emixustat development for GA

Otsuka Pharmaceutical (Tokyo) terminated its agreement to jointly develop emixustat after a phase 2b/3 study failed to meet its primary endpoint for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), co-developer Acucela (Seattle) said in a press release. Acucela plans to continue its phase 2 trial of emixustat addressing proliferative diabetic retinopathy and plans to initiate a clinical trial evaluating emixustat in patients with Stargardt disease by the end of 2016.

RESEARCH BRIEFS

  • A proposed new grading system and associated treatment guidelines for the acute ocular manifestations of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) may help facilitate evaluation and management of these disorders, according to Darren Gregory, MD. In his prospective case series, 79 consecutive patients (158 eyes) were evaluated and treated for acute ocular involvement in SJS or TEN during hospitalization. Cases graded as mild or moderate were managed medically. All had best corrected visual acuity (BCVA) of 20/20, no dry eye symptoms, and no scarring sequelae. Cases graded as severe or extremely severe were treated with urgent amniotic membrane transplantation in addition to medical management. Severe cases all had BCVA of 20/20 and mild or no dry eye problems. Five of 28 patients had mild tarsal conjunctival scarring. No other scarring sequelae occurred. Nine of the 10 extremely severe cases had BCVA of 20/20 (1 was 20/30). Three of 10 had moderate scarring of the tarsal conjunctiva and lid margins and also moderate dry eyes with severe photophobia. Seven of 10 had only mild or no dry eye symptoms and scarring sequelae. Dr. Gregory suggested mild and moderate cases have a low risk of significant scarring or visual sequelae and may be monitored and treated medically if not worsening. Severe and extremely severe cases should receive urgent amniotic membrane transplantation to decrease the risk of scarring and visual sequelae. The study is published online ahead of print in Ophthalmology.
  • Descemet's stripping automated endothelial keratoplasty (DSAEK) surgery leads to considerable improvement in patient-reported outcomes in Fuchs' endothelial corneal dystrophy (FECD) patients, according to a new study. E. Nielsen and colleagues prospectively enrolled 41 FECD patients who received DSAEK and compared results to 40 cataract patients with normal corneas who received cataract surgery (control group). Subjects were recruited between March 2013 and July 2014. Best corrected visual acuity (BCVA) negatively correlated with anterior higher order aberrations (HOAs) (p<0.001) and central corneal thickness (p=0.001). Contrast sensitivity (CS) was negatively correlated with anterior HOAs (p=0.002) and positively correlated with posterior densitometry (p=0.008). Catquest-9SF effect size was 1.32 (CI: 1.0-1.6) in the control group, 1.84 (CI: 1.4-2.3) in FECD patients who received phacoemulsification and intraocular lens implantation in combination with DSAEK (n=26), and 1.37 (CI: 0.6-2.1) in pseudophakic FECD patients who received DSAEK (n=15). The study is published in Acta Ophthalmologica. 
  • Myopia and astigmatism were associated with increased severity of haze, and older age was protective against early corneal haze development after photorefractive keratectomy (PRK) in an Asian population, according to outcomes from the Singapore Armed Forces Corneal Refractive Surgery Programme. Bryan Chin Hou Ang, MMed (Ophth), and colleagues retrospectively evaluated 177 patients (347 eyes) who underwent PRK at a tertiary eye center in Singapore. The majority of the patients were Chinese (98.3%) and men (98.3%). The mean preoperative spherical equivalent (SE) was −3.34±1.19 D. One hundred thirty-five eyes (38.9%) had PRK with mitomycin-C. Ten eyes (2.9%) had enhancement surgery. The overall efficacy index was 0.88, and the safety index was 1.07. At 3 months, 187 eyes (53.9%) had no haze, 76 eyes (21.9%) had a haze grade of more than 0 and less than 1, 76 eyes (21.9%) had a haze grade of 1 or more and less than 2, and 8 eyes (2.3%) had grade 2 haze. The study is published in the Journal of Cataract & Refractive Surgery.

NEW PRODUCT BRIEFS

  • Bausch + Lomb (Bridgewater, New Jersey) introduced PreserVision AREDS 2 Formula + Multivitamin. PreserVision combines the AREDS2 study formula with other essential vitamins and minerals typically found in daily multivitamins. The product was created in response to consumer feedback and data that showed that 90% of the participants in the AREDS2 clinical study who took an AREDS supplement also took a daily multivitamin.

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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