CAMBRIDGE, MA, AUGUST 17, 2020 – Neuroptika, a privately held biotechnology company focused on the development of novel regenerative treatments for ophthalmic diseases, today 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.
Neuroptika is a clinical stage biotechnology company formed in December 2018 as a spin out of Senju Pharmaceutical Co., Ltd, a privately held pharmaceutical company based in Japan. Neuroptika is developing NRO-1, a novel therapeutic that protects and regenerates corneal nerves. NRO-1 has generated compelling data demonstrating accelerated nerve regeneration which led to the recovery of functional nerves and corneal sensitivity in animal studies. A successful Phase 1 SAD/MAD trial was completed and a Phase 2 trial for dry eye disease has completed enrollment. While most dry eye treatments are focused on treating signs and symptoms, NRO-1 has the potential to become the first disease modifying regenerative treatment. NRO-1’s benefit is also being studied in other indications, including neurotrophic keratitis, LASIK-induced neurotrophic epithealiopathy, glaucoma and Leber's hereditary optic neuropathy. Our mission is to improve patients’ lives by developing novel regenerative treatments for ophthalmic diseases. For more information, please visit www.neuroptika.com