EW Weekly, March 21, 2014

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March 21, 2014
Volume 19 , Number 8

FDA panel votes in favor of toric ICL

The U.S. Food and Drug Administration's Ophthalmic Devices Panel of the Medical Devices Advisory Committee has issued a favorable opinion on the Visian Toric Implantable Collamer Lens (TICL, STAAR Surgical, Monrovia, Calif.).
The proposed indications for use of the Visian TICL, as presented during the panel meeting, were as follows:

  • for the correction of myopic astigmatism in adults 21–45 years with spherical equivalent ranging from –3.0 D to ≤ –15.0 D with cylinder of 1.0 D to 4.0 D;
  • for the reduction of myopic astigmatism in adults 21–45 years with spherical equivalent ranging from greater than –15.0 D to –20.0 D with cylinder 1.0 D to 4.0 D;
  • with an anterior chamber depth (ACD) of 3.0 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5 D for 1 year prior to implantation); and
  • the Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.

Avedro receives complete response letter for CXL NDA

The U.S. Food and Drug Administration identified “a number of areas” that require additional information from developer Avedro (Waltham, Mass.) on its New Drug Application (NDA) for the riboflavin ophthalmic solution/KXL System, the company said. The company plans to work closely with the FDA to address the issues. If approved, the riboflavin ophthalmic solution/KXL System would be the first FDA approved therapeutic treatment for keratoconus and corneal ectasia.

Sustained release dexamethasone starts phase 3 study

A phase 3 study to evaluate the safety and efficacy of a sustained release dexamethasone bioabsorbable intracanalicular plug has started, said developer Ocular Therapeutix (Bedford, Mass.). In the first of two prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled studies, 240 patients undergoing clear corneal cataract surgery will be enrolled at sites throughout the United States. Following surgery, patients will be randomized to either the dexamethasone treatment group or a placebo vehicle plug. Primary endpoints are absence of anterior chamber cells at day 14 and reduction of pain at day 8; the plug is designed to release the steroid to the ocular surface for up to 30 days, the news release said.

Physical activity, occasional drinking may reduce risk of visual impairment

A physically active lifestyle and occasional drinking are associated with a reduced risk of developing visual impairment, according to a study published by the American Academy of Ophthalmology (San Francisco).
According to the study, researchers from the University of Wisconsin School of Medicine and Public Health examined the relationships between the incidence of visual impairment and three modifiable lifestyle behaviors: smoking, drinking alcohol, and staying physically active. The research was conducted as part of the Beaver Dam Eye Study, a long-term population-based cohort study from 1988 to 2013 of nearly 5,000 adults aged 43 to 84 years.
Over 20 years, 6.7% of sedentary persons and 2% of physically active persons developed visual impairment. Over 20 years, 11% of non-drinkers (people who have not consumed alcohol within the past year) developed visual impairment while 4.8% of occasional drinkers did so.
While the odds were higher in heavy drinkers and smokers compared to people who never drank heavily and never smoked, respectively, the associations were not statistically significant.

Smartphone adapters capture high-quality anterior/posterior images

Researchers at the Stanford University School of Medicine have developed two inexpensive adapters that enable a smartphone to capture high-quality images of the anterior and posterior segments, the school said in a news release. The adapters were developed by ophthalmology resident David Myung, MD, and assistant professor of ophthalmology Robert Chang, MD. Dr. Myung said he wanted point-and-shoot ability in seconds, not minutes, with instant upload to a secure server. More importantly, the team envisioned the device to be readily usable by any healthcare practitioner, not just ophthalmologists.
Drs. Myung and Chang have recently been awarded seed grants from the School of Medicine and the Stanford Biodesign Program to fund the production of the initial batch of adapters, currently dubbed EyeGo, for distribution and continued evaluation.

RESEARCH BRIEFS

  • There was close agreement in refraction between surgeons and optometrists using a standard manifest refraction protocol of less than 0.25 D, according to D. Reinstein and colleagues. Their retrospective case series comprised 1,922 patients attending two preoperative refractions before laser vision correction. The first manifest refraction was performed by one of seven optometrists and the second manifest refraction by one of two surgeons, all trained using a standard manifest refraction protocol. Patients were stratified into a myopia group and a hyperopia group and then further stratified by each surgeon-optometrist combination. The mean surgeon-optometrist dioptric power difference was 0.21 D (range 0.15 to 0.32 D). The mean difference in spherical equivalent refraction was 0.03 D, with 95% of all refractions within 0.44 D for all optometrist-surgeon combinations. The study is published in the Journal of Cataract & Refractive Surgery.
  • In assessing the perceptions of 100 eyecare providers regarding the clinical management of dry eye, providers reported burning (46.5%) as the most frequent symptom described by patients, followed by foreign body sensation (30.3%) and tearing (17.2%), according to a new report. J.F. Williamson and colleagues also reported most respondents (80.8%) listed artificial tears as the recommended first-line treatment, even though providers reported high failure rates for both artificial tears and topical cyclosporine 0.05%. Rheumatoid arthritis, Sjogren syndrome, affective disorders such as anxiety and depression, history of photorefractive surgery, smoking, and thyroid disease were acknowledged as common comorbid conditions. The study is published in Eye & Contact Lens, and the authors noted the survey “underscores the incongruence when comparing subjective symptoms with objective signs, thereby highlighting the urgent need for the development of reliable metrics to better quantify dry eye symptoms and also the development of a more sensitive and specific test that can be used as the gold standard to diagnose dry eye.”

NEW PRODUCT BRIEFS

  • Carl Zeiss Meditec (Jena, Germany) introduced a surgical microscope with integrated intraoperative OCT, the Opmi Lumera 700 and ReScan 700. According to the company, the new microscope allows surgeons to “see even transparent structures of the eye during surgery, monitor progress during a procedure and verify clinical results in the OR.”
  • Nicox (Sophia Antipolis, France) launched Xailin, a new range of tear lubricants for relief of dry eye symptoms, and AdenoPlus, an in vitro diagnostic medical device to help the differential diagnosis of acute conjunctivitis. Nicox is now promoting and selling the products through its own sales force in the U.K., Italy, Spain, and France. Commercial operations in Germany are expected to begin in the second quarter of 2014. Nicox in-licensed AdenoPlus from Rapid Pathogen Screening in 2012.
  • Macular Health (Birmingham, Ala.) has introduced MacuStrip Premier, its new Oral Thin Film (OTF) delivery method. According to the company, the OTF technology provides “maximal delivery of nutrients by using higher concentrations of the active ingredients shown by the AREDS 2 study to be most effective in slowing or preventing vision loss due to age-related macular degeneration by placing them on an easy-to-use OTF strip that is applied to the cheek or tongue.”
  • Bausch + Lomb (Rochester, N.Y.) has introduced PeroxiClear 3% hydrogen peroxide cleaning and disinfecting solution, which has been shown to keep contact lenses cleaner and more moist for longer than other peroxide solutions, according to the company. PeroxiClear solution will be available in major retailers starting next month, with a national rollout by June.

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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