A successful Phase 1 clinical study to determine the safety, tolerability, and pharmacokinetics of topical NRO-1 in healthy subjects is complete.
The Phase 1 clinical study was a randomized, double-blind, placebo controlled, single ascending dose (SAD) and multiple ascending dose (MAD) single center study in 36 healthy volunteers.
Key results from the NRO-1 SAD and MAD clinical study
Well tolerated across entire dose range, all patients completed dosing in both the SAD and MAD portions
No serious or severe adverse events and no dose response in adverse events
No clinical chemistry, hematology or ECG safety concerns
Safety profile consistent with preclinical data and supportive of continuing to Phase 2
Dry Eye Disease
Based on the positive results from the Phase 1 single and multiple ascending dose study, a Phase 2 clinical study of NRO-1 in dry eye disease was initiated in January 2020.
Rationale for NRO-1 in
Dry Eye Disease:
Existing treatments for dry eye disease are focused on symptomatic therapy and are considered to be 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 by promoting the regeneration of damaged corneal sensory nerves, thereby normalizing the ocular surface and improving the symptoms of dry eye.
Phase 2 Overview:
Multicenter, randomized, double-masked, vehicle-controlled clinical trial that will evaluate the safety and efficacy of NRO-1 in patients with dry eye disease
120 patients with moderate-to-severe dry eye disease, including post-surgical patients
2 dosages of NRO-1 compared to vehicle (placebo)
Study initiated in January 2020, with results available in 2H 2020