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

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 studyassessments and visits;
• Have stage 2 or 3 neurotrophic keratopathy in at least one eye If a female ofchildbearing potential, have a negative urine pregnancy test at Visit 1 and agree touse 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 ofthe investigator may interfere with the study parameters;
• Have significant blepharitis, meibomian gland dysfunction (MGD), lid margininflammation or active ocular allergy that requires treatment
• Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of theinvestigator, is the primary cause of the persistent epithelial defect;
• Be diagnosed with ongoing ocular infection (bacterial, viral or fungal) or activeinflammation (e.g. follicular conjunctivitis) not related to NK
• Anticipate the use of fluoroquinolone-containing antibiotic eye drops during thestudy;
• Have used contact lenses (excluding therapeutic contact lenses) within 14 days priorto Visit 1 or anticipates use of contact lenses during the study period;
• Have an uncontrolled systemic disease that in the opinion of the investigator mayinterfere with the study parameters;
• Anticipate a change in immunosuppressive therapy during the course of the study;