DRY EYE DISEASE
16.4 million adults have dry eye in the United States
IMPACT OF DRY EYE
Dry eye impacts 5-30% of people age ≥50 years  
The dry eye population is expected to grow rapidly as the U.S. ages
Dry eye disease is a multifactorial disease of the tears and ocular surface that can result in ocular discomfort and visual impairment.  Based on data from the National Health and Wellness Survey, 16.4 million adults have been diagnosed with dry eye in the United States.  Previous studies evaluating the impact of dry eyes on quality of life show that patients with moderate to severe dry eye report utility scores similar to patients with moderate to severe angina or patients receiving dialysis.  
DRY EYE DISEASE PATHOGENSIS

Dry eye occurs when a person doesn't have enough quality tears to nourish the eye  

Lacrimation (tear secretion) is necessary to maintain the health of the front surface of the eye and for clear vision. Dry eye is a common and often chronic problem, particularly in older adults. 

 

Corneal degeneration is often observed in patients diagnosed with dry eye. Many studies have found that that the breakage and degeneration of corneal nerve axons are strongly related to decreased lacrimation and corneal epithelium disorder. These studies suggest that the degeneration of corneal sensory nerves causes ocular surface disorders that cause dry eye. 

 

Corneal nerve regeneration may be a novel treatment option for the underlying cause of the disease. 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
MANAGEMENT AND TREATMENT
NRO-1 could be the first disease modifying agent  
Approved therapies for dry eye are inadequate and are solely focused on treating signs and symptoms
Current treatments for dry eye disease are suboptimal and are aimed at increasing or supplementing tear production, slowing tear evaporation, reducing tear resorption, or reducing ocular surface inflammation. The primary methods used to manage and treat dry eye include adding tears using artificial tear solutions, conserving tears, increasing tear production, and treating the inflammation of the eyelids or eye surface that contribute to dry eyes.  While there are approved treatments for dry eye, including Restasis ($1.4 billion in 2017 sales) and Xiidra (sold to Novartis for $5 billion+ in 2019), these therapies are inadequate and are solely focused on treating signs and symptoms.  There are no approved disease modifying agents. NRO-1 is the only therapeutic in development targeting glial cell-derived neurotrophic factor (GDNF) and has the potential to become the first regenerative treatment for dry eye disease.