CONTACT NEUROPTIKA

1770 Massachusetts Avenue, Suite 163 Cambridge, MA  02140

United States

Copyright, Neuroptika 2019. All rights reserved.  Terms of site use  |  Privacy Policy

NRO-1 PROGRAMS

NRO-1 has successfully completed a Phase 1 study.  A Phase 2 study for dry eye disease is ongoing.

PHASE 1

PHASE 2

PRECLINICAL

SAD/MAD

2019

PHASE 1

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.

  • 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

Key results from the NRO-1 SAD and MAD clinical study

.

.

Dry Eye Disease

2020

PHASE 2

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.​

​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.

Rationale for NRO-1 in

Dry Eye Disease:

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

 

BACK TO TOP