Quick Notes: June 11, 2020

  • Vasoptic Medical received 501(k) clearance from the FDA for its XyCAM RI noninvasive retinal imager. The device images retinal vessels and blood flow and features include spatio-temporal resolution, measurement reproducibility and flow-sensitivity over a wide range. Vasoptic intends to continue to collaborate with academic research institutions to gather clinical evidence to support the expanded use of the XyCAM RI in specific disease conditions.
  • Aldeyra Therapeutics reached an agreement with the FDA for the use of reactive aldehyde species (RASP) as an objective sign for the treatment of dry eye disease. RASP are pre-cytokine pro-inflammatory mediators that are elevated in the tears of patients with dry eye disease and correlate with dry eye disease symptoms and signs. Aldeyra has a first-in-class RASP inhibitor currently in a Phase 2a dry eye disease clinical trial; the inhibitor has demonstrated reduction in tear RASP levels after 28 days of treatment. 

  • Johnson & Johnson, via its Janssen Pharmaceutical Companies division, accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July. The study, which will take place in the United States and Belgium, will evaluate the safety, reactogenicity and immunogenicity of the vaccine in 1,045 adults aged 18 to 55 years, as well as adults aged 65 years and older.
  • Zeiss reached a new milestone with its SMILE procedure with more than 3 million patients treated worldwide. SMILE is performed with the VisuMax femtosecond laser and is a minimally-invasive corneal refractive procedure.   
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