Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1

Neurotrophic keratopathy (NK) is a degenerative corneal disease that occurs as a result of
partial or total impairment of trigeminal innervation. The resulting loss of corneal
sensitivity (anesthesia) leads to a reduction in lacrimation and a decline in status,
metabolism, and mitosis of corneal epithelial cells. Previous studies (physician-sponsored
studies) used to treat to nine patients with NK, six of whom had discrete geographic,
non-healing lesions, and three of whom had punctate lesions and the study result reported.

Inclusion Criteria:

- Be male or female of any race, at least 18 years of age

- Have provided verbal and written informed consent.

- Be able and willing to follow instructions, including participation in all study
assessments and visits;

- Have stage 2 or 3 neurotrophic keratopathy in at least one eye If a female of
childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to
use an adequate method of birth control throughout the study period.

Exclusion Criteria:

- Have any clinically significant slit lamp findings at Visit 1 that in the opinion of
the investigator may interfere with the study parameters;

- Have significant blepharitis, meibomian gland dysfunction (MGD), lid margin
inflammation or active ocular allergy that requires treatment

- Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the
investigator, is the primary cause of the persistent epithelial defect;

- Be diagnosed with ongoing ocular infection (bacterial, viral or fungal) or active
inflammation (e.g. follicular conjunctivitis) not related to NK

- Anticipate the use of fluoroquinolone-containing antibiotic eye drops during the
study;

- Have used contact lenses (excluding therapeutic contact lenses) within 14 days prior
to Visit 1 or anticipates use of contact lenses during the study period;

- Have an uncontrolled systemic disease that in the opinion of the investigator may
interfere with the study parameters;

- Anticipate a change in immunosuppressive therapy during the course of the study;