EW Weekly, August 31, 2018

August 31, 2018
Volume 24 , Number 32

Alcon announces voluntary global market withdrawal of CyPass Micro-Stent

Alcon (Fort Worth, Texas) announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. Alcon advises surgeons to immediately cease further implantation of the CyPass and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of 5-year post-surgery data from the COMPASS-XT long-term safety study. At 5 years, the CyPass group experienced statistically significant endothelial cell loss compared to the group that underwent cataract surgery alone, according to a company press release. Alcon will be communicating directly with surgeons with recommendations for evaluating and managing those patients who have already received a CyPass and instructions for returning unused devices, according to a company press release.

Agent for postop eye pain approved by the FDA

The FDA has approved loteprednol etabonate ophthalmic solution (Inveltys, Kala Pharmaceuticals, Waltham, Massachusetts) 1% to treat pain and inflammation after eye surgery. Inveltys is the first topical ocular corticosteroid with twice-daily dosing instead of dosing four times a day, according to a company press release. It is also the first product to use Kala's mucus-penetrating particle technology. Inveltys is contraindicated for most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis, vaccinia, and varicella. Kala leaders plan to launch Inveltys in early 2019.

Orphan Drug designations submitted for cannabis therapies

Tetra Bio-Pharma (Ottawa, Canada) has submitted multiple applications for Orphan Drug designation for cannabinoids to the FDA to treat various forms of rare cancers and ocular diseases, according to a company press release. "If successful, the designation of cannabinoids as an Orphan Drug will open the door for fast track approval, tax credits on clinical research, and reduced registration fees, in addition to other opportunities," according to a company press release.

Early signs of Alzheimer's disease may be seen with OCT findings

Retinal microvascular abnormalities in cognitively healthy individuals may be seen in patients with preclinical Alzheimer disease, according to Bliss Elizabeth O'Bryhim, MD, and coresearchers, in a report published in JAMA Ophthalmology. Their single-center, case-control study used OCT angiography to possibly detect early retinal alterations in cognitively normal study participants with preclinical Alzheimer disease that was diagnosed by biomarker testing. Among the 30 study participants, 14 had biomarkers positive for Alzheimer disease, and 16 patients served as the control group. In the biomarker-positive group, the foveal avascular zone was increased (mean, 0.364 vs. 0.275 mm2,  P=.002). The mean inner foveal thickness was decreased in the biomarker positive group. Longitudinal studies in larger cohorts are necessary to see if the finding can effectively identify preclinical Alzheimer disease, the researchers concluded.

Submissions now open for the 2019 ASCRS/ASOA Annual Meeting

Submissions for the 2019 ASCRS/ASOA Annual Meeting are now open. Get involved and help shape the 2019 Annual Meeting program by submitting instructional courses, scientific films, papers, posters, and photos. The deadline to submit courses, films, papers, and posters is Wednesday, October 17. The deadline for photo submissions is Friday, January 11, 2019. The 2019 ASCRS/ASOA Annual Meeting is being held May 3-7 in San Diego. Detailed information is now available on the Call for Submissions website. Please read the 2019 ASCRS/ASOA Annual Meeting Submission Guide before submitting your entry. All program participants are required to pay for their meeting registration. Housing is currently open, and registration will open later this year.


Research briefs
  • There is a high variation in trabeculectomy and glaucoma drainage device placement among various regions in the U.S., reported Cheryl Khanna, MD, and coresearchers. Their study was an observational cohort of a Medicare claims database. They found that patients in the South or the Midwest were significantly more likely to receive a glaucoma drainage device placement compared to patients in the Northeast. The characteristics associated with greater odds of receiving a glaucoma drainage device included: an age of 84 years or older, African American race, and an ICD-9-CM diagnosis of glaucoma associated with vascular disorders. Glaucoma drainage device placement also was more likely to be performed by early-career surgeons. The study appears in Ophthalmology Glaucoma.
  • In a prospective case series of patients presenting for cataract surgery, 56.7% had abnormal osmolarity, and 63.3% had abnormal matrix metalloproteinase-9 levels, indicating a high percentage of patients with ocular surface dysfunction, reported Preeya Gupta, MD, and coresearchers. Many times, ocular surface dysfunction remains undiagnosed, the researchers wrote. Among the 120 patients in the study, the mean age was 69.5 years, and 69% of the patients were women. About 39% of patients had positive corneal staining on presentation, 7.5% had epithelial basement membrane dystrophy, and 1.6% had Salzmann's nodules. On a questionnaire, 54% of 100 patients reported symptoms that suggested ocular surface dysfunction. Among an asymptomatic group of 46 patients, 85% had at least one abnormal tear test. Overall, 80% of the 120 patients had one or more abnormal tear test result, and 40% had two abnormal results. The results are published in the Journal of Cataract & Refractive Surgery.
  • A urine biomarker could be effective in identifying onchocerciasis, or river blindness, reported Ryan Shirey and coresearchers. Onchocerciasis is the second-leading cause of preventable blindness and remains a burden despite the availability of the treatment ivermectin. The lack of a reliable point-of-care diagnostic for an active Onchocerca infection has been a limiting factor. The authors had previously published the discovery of the biomarker N-acetyl-tyramine-O-glucuronide (NATOG) in human urine samples and its ability to track progression of treatment between medicated patients compared with placebo. "The ability of NATOG to distinguish between active and past infection overcomes the limitations of antibody biomarkers and [polymerase chain reaction] methodologies," the authors wrote. Among 27 patients followed by the researchers, a NATOG-based urine lateral flow immunoassay accurately identified onchocerciasis in 85% of patients. The study appears in ACS Infectious Diseases.
  • No benefit is apparent when adding oral voriconazole to topical antifungal agents to treat severe filamentous fungal ulcers, according to Julie Cho and coauthors. They completed a non-prespecified, secondary case control analysis from a multicenter, double-masked, randomized placebo-controlled clinical trial. All who participated had smear-positive filamentous fungal ulcers and a visual acuity of 20/400 or worse and were eventuated to therapeutic penetrating keratoplasty (TPK). The main outcome measure was TPK culture positivity. A total of 49.5% of study participants were eventuated to TPK at a mean of 20.9 days. Of the TPK button cultures available for 71% of the TPKs performed, 67% were positive for filamentous fungus. The patients randomized to oral voriconazole had a 1.26-fold increased odds of TPK button culture positivity after controlling for time to TPK and baseline organism. However, this was not statistically significant (P=.74). Those who had TPK for lack of response to medical therapy were 10.64-fold more likely to be cultural positive than if the surgical indication was for perforation. Infection, not inflammation, appears to be the reason for a worsening clinical picture, the researchers concluded. The study appears in the American Journal of Ophthalmology.

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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