Evidence from Two Pivotal Trials Behind Recent FDA Clearance Presented at the American Society for Cataract and Refractive Surgery
Press Release – updated: May 22, 2020 06:00 EDT
ISSAQUAH, Wash., May 22, 2020 (Newswire.com) –
The clinical evidence for iTEAR100® was presented by Seattle-based Ophthalmologist and dry eye specialist Laura M. Periman, MD at the American Society for Cataract and Refractive Surgery (virtual) meeting on May 18, 2020. These data served as the pivotal trials for the recent FDA clearance to increase tear production in adult patients.
TEAR 2 (CLP OO7) was a double-masked, randomized, sham-controlled multi-center study which enrolled 59 subjects, and TEAR 1 (CLPOO2) was a multi-center single-arm study with a primary endpoint at 30 days and enrolled 108 subjects.
“In TEAR2, the iTEAR100® neurostimulator demonstrated a 22 mm change in the Schirmer score (a standard measure of tear volume) when compared to the results of the sham. There were no device-related adverse events.”
Dr. Periman continued, “TEAR 1 demonstrated the continued ability to increase immediate tear production to 30 days. At the 30-day timepoint, there was a 9.4 mm change from unstimulated to stimulated tear production based on the Schirmer score. There was also an increase in the pre-stimulation Schirmer score from 6 mm at the start of the study to 9.4 mm at 30 days. The device was well-tolerated, with a 2-3% incidence of dizziness and headache during the study. The production of tears and patient satisfaction was seen in even our most severe patients.”
Commenting further, Dr. Paul Karpecki, a leading dry eye expert in Kentucky and investigator in the study said, “I have a complex patient population, so devices are essentially put through rigorous testing; the iTEAR100 excelled and provided significant relief to patients with varying severity levels.”
Dr. Neil Friedman, a cataract and refractive surgeon and dry eye expert in Menlo Park, California, who served as the medical monitor for both studies commented, “I was excited to see the widespread acceptance of this technology by study patients. The iTEAR100 device is easy to use, effective at rapidly producing tears, and well-tolerated. I look forward to providing this wonderful technology to my patients in the near future.”
“We are excited about the FDA clearance and outcomes of our studies and look forward to offering a drug-free alternative for adult patients who will benefit from increased tear production,” said CEO Dr. Michael Gertner, inventor of the technology and founder of the company.
The iTEAR100® Neurostimulator is a stand-alone, pocket-size device requiring only a 30 second or less application to the skin of the external nasal region. Its application stimulates the trigeminal nerve, which results in activation of the parasympathetic nerve pathway that controls tear film homeostasis. Demonstrated in trials to be well tolerated and effective at temporarily increasing acute tear production, the iTEAR100® is a cost-effective option. It will be supplied through eye care provider channels for adults who would benefit from increased production of tears.
About Olympic Ophthalmics, Inc.
Olympic Ophthalmics, Inc. is a medical technology company pioneering simple, high-value treatments for ophthalmic diseases through neuromodulation. The company is based in Issaquah, Washington, and backed by lead venture capital investor BioStar Capital.
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Source: Olympic Ophthalmics