NEUROTROPIC KERATITIS
65,000 people in the United States have Neurotrophic Keratitis
NEUROTROPHIC KERATITIS
Neurotrophic keratitis (NK) is a rare degenerative corneal disorder caused by impaired corneal innervation
NK is characterized by reduced corneal sensitivity, spontaneous corneal epithelium breakdown, and impaired corneal healing.  Many conditions that damage the corneal nerves including herpetic keratitis, diabetes and surgical procedures can cause patients to develop NK.  The disease can lead to a variety of complications, including poor wound healing of the cornea, scarring of the cornea, and loss of vision. 
RATIONALE FOR NEUROTROPHIC KERATITIS:

NRO-1 recovers ocular surface function through regenerating corneal nerves and directly accelerating corneal wound healing

MANAGEMENT AND TREATMENT
NRO-1has an ideal product profile for the treatment of NK

There is currently one approved therapy for NK, recombinant human nerve growth factor (rhNGF; cenegermin), which has a number of deficiencies, including high discontinuation rates due to adverse events (17%  ) in clinical trials, as well as a lack of convenience (refrigerated product delivered via pipette six times per day).

 

NRO-1 has the potential to become the ideal therapy for physicians and patients by addressing the key deficiencies of rhNGF.  

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The key differentiators of NRO-1 are:

  • NRO-1 is a topically delivered small molecule that can be stored at room temperature

  • NRO-1 targets glial cell derived neurotrophic factor (GDNF) as opposed to nerve growth factor (NGF), which is associated with increased pain

  • Safety and tolerability are similar to vehicle in a Phase 1 SAD/MAD clinical study

We plan to initiate a Phase 2 study with NRO-1 in patients with neurotrophic keratitis in 2021