Neuroptika, a privately held biotechnology company focused on the development of novel regenerative treatments for ophthalmic diseases, has enrolled its first patient in a phase two clinical trial of NRO-1, intended for the treatment of dry eye disease, it was reported on Friday.
The product is a novel therapeutic with the potential to protect and regenerate corneal nerves in ophthalmic diseases.
The Phase two clinical trial is a multicentre, randomised, double-masked, vehicle-controlled clinical trial that will assess the safety and efficacy of NRO-1 in patients with dry eye disease. It will test two concentrations of NRO-1 against vehicle over 28 days of treatment in 120 patients with moderate-to-severe dry eye disease, including post-surgical patients. The endpoints will include standard signs and symptoms characteristic of dry eye disease and will also include nerve morphology imaging and biomarker analysis. Results from the Phase two study will be provided in the second half of 2020.
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