EyeWorld Weekly Update, January 12, 2018

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January 12, 2018
Volume 24 , Number 2

First patient enrolled in Phase 2 trial of NOV03 for dry eye

Novaliq GmbH (Heidelberg, Germany) has begun the randomization of patients in its Phase 2 clinical trial for dry eye treatment. The trial is called SEECASE, and the company's treatment, NOV03, may become the first non-blurring, water and surfactant-free treatment for dry eye patients, according to a company press release. The multicenter, randomized, double-masked, saline-controlled study evaluates NOV03 at two different dosing regimens (two and four instillations a day) for the signs and symptoms of dry eye disease. Novaliq also announced this week the formulation of its new subsidiary, Novaliq Inc., which will be located in Cambridge, Massachusetts.

MCG Compliancy partners with The Guard to simplify HIPAA compliance

MCG Compliancy (Springfield, Missouri), a company of Medical Consulting Group, has partnered with compliance software company The Guard to simplify HIPAA compliance and redirect practice and ambulatory surgery center time and energy back to running the business and caring for patients, according to a company press release. An MCG compliance implementation specialist guides clients through implementation of the software to identify compliance breaches, assists with building a remediation plan, and administers ongoing maintenance.

Topline results announced for STRIDE 1 and STRIDE 2 Phase 3 trials for dry eye

Topline results from the Short Term Relief in Dry Eye (STRIDE 1 and STRIDE 2) Phase 3 clinical trials were announced this month by Kala Pharmaceuticals (Waltham, Massachusetts). Both trials focused on the efficacy of KPI-121 0.25% compared with placebo in patients with dry eye disease. In STRIDE 1, with 918 patients, statistical significance was achieved for the primary sign endpoint of conjunctival hyperemia change from baseline to day 15 and ocular discomfort severity change from baseline to day 15 in patients with more severe baseline ocular discomfort. However, statistical significance was not achieved for the second pre-specified primary sign endpoint of inferior corneal staining change from baseline to day 15. The STRIDE 2 trial (909 patients) achieved statistical significance for the primary sign endpoint of conjunctival hyperemia change from baseline to day 15 but not for the primary symptom endpoint of ocular discomfort severity change from baseline to day 15, even though a positive treatment effect was observed at day 8. In both trials, KPI-121 was well tolerated. Company leaders said in a press release they will continue to analyze results from their Phase 3 trials and expect to discuss their clinical program with the U.S. Food and Drug Administration (FDA).

NDA submitted for Durasert for 3-year posterior segment uveitis treatment

The company pSivida (Watertown, Massachusetts) submitted a New Drug Application (NDA) to the FDA for the treatment of posterior segment uveitis with 3 years of treatment from Durasert. Submitted data include results from two Phase 3 studies that each met the primary efficacy endpoint at 6 months with a P value <0.001, according to a company press release. The safety profile of patients treated with Durasert for posterior segment uveitis over 3 years was consistent with the safety profile of steroid treatments that are currently standard of care, according to the company. The FDA will determine if the company's NDA is complete and acceptable for review.

European filing for Iluvien in Europe accepted

Alimera Sciences (Atlanta) received validation of a type II variation for Iluvien that was submitted last month through the Mutual Recognition Procedure with the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. "The submission to the MHRA and 16 European member states seeks to add the indication of recurrent and persistent non-infectious uveitis affecting the posterior segment to the Iluvien label in Europe," the company stated in a press release. "All 17 bodies have accepted the submission." The data Alimera submitted comes from two randomized, double-masked Phase 3 clinical trials with a primary 6-month endpoint comparing the proportion of patients who did not have a recurrence of posterior segment non-infectious uveitis. The primary endpoint was met in both trials. Iluvien is a sustained release intravitreal implant currently indicated in Europe for vision impairment associated with chronic diabetic macular edema that does not respond to available therapies.

RESEARCH BRIEFS

  • Asthma and allergic rhinitis were significantly associated with the development of cataracts in a study led by Young Bok Lee and co-researchers. They reviewed data from the Korean National Health and Nutrition Examination Surgery 2010-2012. There were 14,776 participants at least 19 years old included in the study; researchers used multiple logistic regression analysis to evaluate the odds ratios for cataract and glaucoma as they related to the presence of allergic diseases. Atopic dermatitis was not associated with cataract and glaucoma development. The research is published in the Journal of Dermatology.
  • Ocular injuries during pediatric sports and recreation activities are still common, and prevention efforts should continue to increase, particularly for eye injuries associated with non-powder guns, according to Krystin Miller and co-researchers in their report of pediatric eye injuries treated in U.S. emergency departments. Researchers analyzed data from 1990 to 2012 from the National Electronic Injury Surveillance System; an estimated 441,800 children were treated for sports- and recreation-related eye injuries during that time, for an average of 26.9 injuries per 100,000 children. The highest rate of eye injury occurred in children 10 to 15 and 15 to 17 years old. Three-fourths of the eye injuries were in boys. Corneal abrasion was the most common type of eye injury (27.1%), followed by conjunctivitis (10%) and foreign body in the eye (8.5%). Basketball was the activity most associated with eye injury (15.9%), followed by baseball and softball (15.2%) and non-powder guns (10.6%). Although the overall rate of eye injury decreased slightly, the rate of eye injury associated with non-powder guns grew by 168.8%. The study appears in the journal Pediatrics.
  • The cost of postoperative topical antibiotics varies widely and depends on the drug and dosing regimen, according to a prospective lab investigation led by Eric Crowell, MD. Investigators aimed to provide information on the actual fill level and cost of currently available antibiotic eye drops used perioperatively. Moxifloxacin, gatifloxacin (generic and branded), besifloxacin, levofloxacin, ciprofloxacin, ofloxacin, trimethoprim/polymyxin B, tobramycin, and gentamicin were tested. The actual bottle-fill volume and number of drops in each bottle were measured using 10 bottles from each formulation. The percentage of the bottle used as well as the perioperative cost, based on average wholesale price, were calculated based on several dosing regimens. For medications with sticker volumes of 5 mL or greater, all but two agents (ofloxacin four times a day for 14 day and gentamicin four times a day for 14 days) covered two perioperative courses. Besifloxacin had a fill volume less than sticker volume. The most cost-effective prophylaxis was trimethoprim/polymyxin B. Cost considerations will become increasingly important because of the aging population, the researchers concluded. The study appears in the Journal of Cataract & Refractive Surgery.
PRODUCT NEWS
  • The Stellaris Elite Vision Enhancement System (Bausch + Lomb, a subsidiary of Valeant Pharmaceuticals, Laval, Canada) received the CE mark from the European Commission. The system includes Vitesse, its hypersonic, open-port vitrectomy system.

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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