Neuroptika announces enrolment of first patient in phase 2 clinical trial for dry eye disease

NRO-1 is a novel therapeutic with the potential to protect and regenerate corneal nerves in ophthalmic diseases.

“Existing treatments for dry eye disease are focused on symptomatic therapy and are considered inadequate by many physicians and patients.  Corneal nerve degeneration is often observed in patients diagnosed with dry eye and we believe that NRO-1 has the potential to become a disease modifying treatment.  NRO-1 promotes the regeneration of damaged corneal sensory nerves thereby normalizing the ocular surface and improving the symptoms of dry eye,” said Tim Min, Chief Executive Officer of Neuroptika.

“Based on the positive results from the Phase 1 single and multiple ascending dose study, we are pleased to initiate the Phase 2 clinical trial and look forward to the continued development to bring a novel, regenerative treatment option to patients suffering from dry eye disease.”

The Phase 2 clinical trial is a multicenter, randomized, double-masked, vehicle-controlled clinical trial that will evaluate the safety and efficacy of NRO-1 in patients with dry eye disease.

The Phase 2 clinical trial 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 2 study will be available in the second half of 2020.

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 is currently enrolling patients.

Source: Company Press Release