EyeWorld Weekly Update, July 28, 2017

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July 28, 2017
Volume 23 , Number 26

Treatment receives Rare Pediatric Disease designation from the FDA

The investigational drug voretigene neparvovec (Luxturna, Spark Therapeutics, Philadelphia) has been designated as a drug for rare pediatric disease by the U.S. Food and Drug Administration (FDA). The designation comes from the FDA's Offices of Orphan Products Development and Pediatric Therapeutics. Voretigene neparvovec may be the first pharmacological treatment for inherited retinal disease and gene therapy for a genetic disease approved in the U.S., according to a company press release. The FDA is currently reviewing the biologics license application for voretigene neparvovec due to confirmed biallelic RPE65 mutation-associated retinal dystrophy under a Priority Review designation. "Under FDA's Rare Pediatric Disease Priority Review Voucher program, companies who receive approval for a new drug application or Biologics License Application for a rare pediatric disease may be eligible to receive a voucher for a Priority Review of a subsequent marketing application for a different product," according to the manufacturer. The Prescription Drug User Fee Act action date is Jan. 12, 2018.

Cenegermin eye drops approved in Europe for neurotrophic keratitis

The European Commission has granted marketing authorization for cenegermin eye drops (Dompé, Milan, Italy) for moderate to severe neurotrophic keratitis. This agent is the first approved for the treatment of this condition, according to a company press release. Cenegermin is the name of the agent's primary active ingredient; it is the recombinant version of human nerve growth factor and is developed and prepared through a biotechnological production process specific for Dompé. Cenegermin is still an investigational product in the U.S.; company leaders have submitted information for its review to the FDA.

Adalimumab granted a positive opinion for uveitis by European Committee

The European Committee for Medicinal Products for Human Use, a division of the European Medicines Agency, has granted a positive opinion for adalimumab (Humira, AbbVie, North Chicago) to treat chronic noninfectious anterior uveitis in pediatric patients with an inadequate response to or intolerance of conventional therapy, or those in whom conventional therapy is not appropriate. The committee's opinion is based on results from a clinical trial called SYCAMORE, which studied the clinical effectiveness and safety of Humira combined with methotrexate versus methotrexate plus placebo to treat active juvenile idiopathic arthritis-associated uveitis. A marketing authorization decision for the agent is anticipated by September, according to a company press release. Adalimumab is already approved in the European Union for noninfectious intermediate, posterior, and panuveitis in adults. Adalimumab is also used for several rheumatological diseases.

Research shows YAG laser vitreolysis improves vitreous floaters

The use of YAG laser vitreolysis subjectively improved Weiss ring-related symptoms and objectively improved Weiss ring appearance in a randomized clinical trial led by Chirag Shah, MD. The trial compared YAG laser vitreolysis versus sham vitreolysis and included 52 eyes (52 patients; 36 cases and 16 controls). Six-month outcomes were a subjective change from 0% to 100% using a visual disturbance score, a qualitative scale, and the National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25). Greater symptomatic improvement was seen in the YAG laser group (54%) compared with controls (9%). The visual disturbance score improved by 3.2 in the treatment group versus 0.1 in the sham group. In the YAG laser group, 19 patients had significantly or completely improved symptoms. There were also improved symptoms in the treatment group using the NEI VFQ-25. Best corrected visual acuity changed by -0.2 letters in the treatment group versus -0.6 letters in the sham group. The research appears in JAMA Ophthalmology.

RESEARCH BRIEFS

  • Satisfactory visual outcomes are achieved in the vast majority of cases following intraoperative complications with small incision lenticule extraction (SMILE, Carl Zeiss Meditec, Jena, Germany) for myopia and myopic astigmatism correction, according to Yan Wang, MD, and coauthors.Their retrospective case series reviewed 3,004 eyes (1,511 patients) who had SMILE and were examined at 1 and 7 days and 1, 3, and 6 months after surgery. Of the 3,004 eyes, 4.46% had intraoperative complications, including suction loss (0.93%) incisional bleeding (0.93%), opaque bubble layer (0.73%), subconjunctival hemorrhage (0.67%), black areas (0.33%), unintended posterior plan dissection (0.33%), lenticule tearing (0.27%), abrasion at the incision (0.17%), and inaccurate laser pulse placement due to eye movement (0.10%). However, all cases resolved instantaneously using management techniques. At 6 months, 99.8% of cases had an uncorrected distance visual acuity of 20/25 or better. The study is published in the Journal of Cataract & Refractive Surgery.
  • Eyecare providers prescribe more branded medications by volume than any other provider specialty, according to Paula Anne Newman Casey, MD, and co-researchers. Their retrospective cross-sectional study evaluated the medications prescribed by eyecare providers through Medicare Part D in 2013. They used that information to calculate medication costs by physician specialty and drug and estimated savings from generic or therapeutic drug substitutions. Eyecare providers accounted for $2.4 billion in Medicare Part D prescription drug costs and had the largest percentage of brand-name medication claims compared with other specialties. Eyecare providers had a significantly higher proportion of monthly supplies by volume for brand medications (38%) compared with 23% for other provider types. Glaucoma medications particularly drove those high costs, followed by dry eye medications-specifically, cyclosporine ophthalmic emulsion (Restasis, Allergan, Dublin). The use of generic medications in place of branded medications would help save $148 million, or a 7% savings, according to the study. It also would help if Medicare was able to negotiate for medication prices offered at U.S. Veterans Affairs rates, the researchers added. The study is published in Ophthalmology.
  • The use of drugs, alcohol, or both are common in ocular trauma treated among emergency department patients, according to research from Sylvia Chang, MD, and co-researchers. Their retrospective, observational study at an urban emergency department in Ohio focused on patients identified by the Trauma Registration from January 2014 through January 2016. Information collected included demographics, cause of injury, visual acuity, slit lamp exam findings, procedures, diagnosis, and eye exams. There were 229 patients reviewed, with a mean age of 44. Of the 143 patients tested for alcohol, 49% tested positive. Of the 98 patients who received a urine toxicologic screen, 63% tested positive for at least one illegal substance, including opiates (19%), cocaine (12%), benzodiazepines (25%), and/or THC (27%). However, researchers found no significant association between substance abuse and emergency department disposition. Most ocular trauma involved the external eye, anterior chamber, orbit, and the globe. The research is published in the American Journal of Emergency Medicine.
  • The seroprevalence of Borrelia burgdorferi (Lyme disease) among patients with uveitis was 7.9% compared with 6% to 8.5% in the general French population, according to Alexia Bernard, and coauthors. Their study focused on determining the frequency and clinical presentation of Lyme disease in patients with uveitis and assessing the value of B. burgdorferi serological testing. The retrospective study analyzed all patients with uveitis who were referred to a tertiary hospital and were serologically tested for Lyme disease in their lab between 2003 and 2016. A diagnosis of Lyme-associated uveitis was diagnosed based on serological results and a response to antibiotics and exclusion of other diagnoses. Among 430 patients with uveitis, 14.7% had an ELISA-positive serology that was confirmed by immunoblot in 7.9%. Lyme-associated uveitis was retained in 1.6% of patients. Among the remaining positive patients, 22 had other established etiologies, and five others were unclassified. The results show a low predictive value of serological testing, which should be reserved for unexplained uveitis, exposure history, systemic findings suggestive of Lyme, and steroid resistance, the researchers concluded. The study appears in theBritish 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; Reay Brown, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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