October 31, 2021

Neuroptika receives final CSR of Phase 2 Clinical Trial in Japan

CAMBRIDGE, MA, OCTOBER 31, 2021 – Neuroptika, a privately held biotechnology company focused on the development of novel regenerative treatments for ophthalmic diseases, today announced completion of Phase 2 clinical trial in Japan. Neuroptika announces today the outcomes of its Phase 2 clinical study evaluating the efficacy of NRO-1 in dry eye disease in Japan.

Despite our rigorous efforts and commitment, the study did not meet its primary endpoint. While this outcome is not the one we had hoped for, we remain dedicated to advancing medical science and fulfilling unmet needs in healthcare. In light of these results, we are shifting our focus towards exploring the potential of NRO-1 in alternative indications.

"We are disappointed by the outcome of the Phase 2 clinical study," said Tim Min, CEO at Neuroptika. "However, we are encouraged by the safety profile of NRO-1 observed throughout the study and are optimistic about its potential in addressing other medical conditions. "The company will continue to analyze the data from the Phase 2 study and collaborate closely with regulatory authorities to determine the next steps for NRO-1 development. Neuroptika remains committed to its mission of improving patients' lives and will continue to pursue innovative solutions to meet healthcare challenges.

About Neuroptika
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

return home