Neuroptika Completes Enrollment of Phase 2 Clinical Trial for Dry Eye Disease

Neuroptika announced completion of enrollment in a Phase 2 clinical controlled, double-masked trial of NRO-1 for the treatment of patients with dry eye disease. NRO-1 is a novel therapeutic with the potential to regenerate corneal nerves in ophthalmic diseases.

"We are pleased to complete enrollment in this Phase 2 clinical trial and look forward to continuing to progress the development of NRO-1. As a potential disease modifying therapy for dry eye disease, NRO-1 may provide physicians and patients a better treatment option," said Tim Min, Chief Executive Officer of Neuroptika. "Given the unprecedent circumstances of 2020, I wholeheartedly thank the patients, investigators, and entire Neuroptika team that has continued to work tirelessly to successfully complete this trial. Following the remaining dosing period and data analysis of the clinical trial, we plan to report topline data in the fourth quarter of this year."

The Phase 2 clinical trial is a multicenter, randomized, double-masked, vehicle-controlled clinical trial that evaluates the safety and efficacy of NRO-1 in patients with dry eye disease. The Phase 2 clinical trial is comparing two concentrations of NRO-1 against vehicle over 28 days of treatment in 124 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.