Quick Notes: May 7, 2020

  • Icare USA launched two new devices: the CenterVue DRSplus Confocal Fundus Imaging System and the Icare ic200 handheld tonometer. The DRSplus uses white LED illumination to produce detailed images. Physicians can view 45˚ images as well as 80˚ images using the Mosaic feature. The ic200 is an updated version of Icare’s line of handheld rebound tonometers, capable of measuring IOP without any anesthetic drops or air puffs. Additions to the ic200 include the ability to test patients while they are sitting, supine or elevated. An updated design and interface includes light indicators confirm the tonometer is positioned properly for measurement.

  • Kala Pharmaceuticals resubmitted its New Drug Application to the FDA for EYSUVIS, (loteprednol etabonate ophthalmic suspension) 0.25%, its product candidate for the short-term treatment of the signs and symptoms of dry eye disease. The NDA was resubmitted in response to a Complete Response Letter the company received from the FDA in August, which requested data from an additional clinical trial. Since then, Kala Pharmaceuticals announced positive results from its STRIDE 3 trial. The company is preparing EYSUVIS for potential U.S. approval and launch by the end of 2020. 

  • Zeiss launched a new section of its website, MED Support Now, which contains information on how to properly disinfect ZEISS equipment, effective social distancing at ophthalmic practices, how to attend Zeiss-sponsored virtual symposia and webinars and more. For more, visit the website.

  • Bausch + Lomb entered into an exclusive partnership with STADA Arzneimittel AGand its development partner, Xbrane Biopharma AB. The companies’ goal is to develop and commercialize a biosimilar candidate to ranibizumab in the United States and Canada. 

  • Santen Pharmaceutical released eyedrop bottles made from environmentally-friendly biomass plastic materials. “Biomass plastic” refers to plastic produced through chemical or biological synthesis from renewable biomass materials that release less carbon dioxide than standard plastic when incinerated. The first product to use the new bottle is Timoptol.

  • A Phase 2 clinical trial of Novai’s DARC (Detection of Apoptosing Retinal Cells) test found it can detect glaucoma progression 18 months than OCT retinal imaging technology. The study, sponsored by University College London, was published in Expert Review of Molecular Diagnostics. The DARC test involves injecting a fluorescent dye into a patient’s arm that then attaches to retinal cells and illuminates those that are in the process of apoptosis. Damaged cells will appear as bright white during examination.

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