Neuroptika has enrolled the first patient in a Phase II clinical trial of NRO-1 for the treatment of dry eye disease.
The multi-centre, randomised, double-masked, vehicle-controlled clinical trial will evaluate the safety and efficacy of NRO-1, a novel therapeutic developed to protect and regenerate corneal nerves.
It will test two dosages of NRO-1 against placebo over 28 days of treatment.
The study will include 120 participants, including post-surgical patients, with moderate-to-severe dry eye disease.
The study endpoints include assessing standard signs and symptoms of dry eye disease, as well as carrying out nerve morphology imaging and biomarker analysis.
Neuroptika CEO Tim Min said: “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 normalising the ocular surface and improving the symptoms of dry eye.”
The Phase II results are scheduled to be available in the second half of the year. NRO-1 has already completed Phase I single and multiple ascending dose study.
Min added: “Based on the positive results from the Phase I single and multiple ascending dose study, we are pleased to initiate the Phase II clinical trial and look forward to the continued development to bring a novel, regenerative treatment option to patients suffering from dry eye disease.”
Neuroptika was established in December 2018 as a spin-out of Japanese pharmaceutical firm Senju Pharmaceutical.
The company focuses on developing novel regenerative treatments for ophthalmic diseases.