NRO-1
Regenerative Therapy for Ophthalmic Diseases
A Novel
Regenerative Treatment
NRO-1 is a topically delivered, nerve regenerative therapeutic that accelerates nerve regeneration and recovery of functional nerves
Corneal Nerve Degeneration
Patients with dry eye often have corneal nerve degeneration, resulting in decreased corneal sensitivity, decreased lacrimation, and corneal and conjunctival epithelium disorder.
Corneal nerves are severed during LASIK surgery causing decreased corneal sensitivity, dry eye like symptoms and other complications.
A rare disease of the corneal epithelium resulting from corneal nerve degeneration and potentially leading to a loss of vision
Retinal Ganglion Cell Degeneration
Glaucoma & Optic Neuropathies
Glaucoma and certain optic neuropathies are neurodegenerative diseases characterized by loss of retinal ganglion cells (RGCs) resulting in vision loss and blindness.
NRO-1 MOA
NRO-1 releases glial cell-derived neurotrophic factor (GDNF), which recovers ocular surface function through regenerating corneal nerves and accelerating corneal wound healing directly
Corneal Sensitivity Recovery
Corneal Nerve Regeneration
Corneal Epithelium Migration
Corneal Wound Healing
NRO-1 permeates to
the back of the eye via
topical application
NRO-1 can reach the target tissues in the back of the eye with efficacious concentrations with BID dosing
NRO-1 promotes axon regeneration and corneal wound healing via release of GDNF
NRO-1 recovers ocular surface function through regeneration of corneal nerves
Topical NRO-1 facilitates axonal regeneration
and recovery of corneal
sensitivity after flap
surgery in rabbits
NRO-1 may decrease complications in patients
after LASIK surgery
NRO-1 induces neurite elongation / regeneration in rat trigeminal ganglion neurons
NRO-1 can regenerate neurons, providing a disease modifying treatment for degenerative diseases
Based on the results from the Phase 1 SAD and MAD clinical studies, a Phase 2 clinical study of NRO-1 in dry eye disease was initiated in the January 2020.
NRO-1 has shown efficacy in a range of nonclinical studies
Nerve damage is linked to a range of ophthalmic diseases, including dry eye disease, creating a high probability of success for human studies
Phase 2
Dry Eye Disease:
Phase 1
Clinical Study:
Well tolerated across the entire dose range, all patients completed dosing in both the SAD and MAD studies.
Study Overview:
Multicenter, randomized, double-asked, vehicle-controlled clinical trial that will evaluate the safety and efficacy of NRO-1in patients with dry eyed disease
120 patients with moderate-to-severe drye disease, including post-surgical patients.
2 dosages of NRO-1 compared to
vehicle (placebo)
Study initiated in Janary 2020, with results available in 2H 2020
Key Results:
Similar safety and tolerability to placebo
No serious or severe adverse events
No clinical chemistry, hematology or ECG safety concerns
Safety profile consistent with preclinical data and supportive of continuing to Phase 2