Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2

Dry eye can be caused by many variable factors. Some examples include hormonal changes due to
aging, or living in an environment of low humidity for long periods of time. Dry eye is a
complex disease that may result in symptoms like discomfort, visual disturbance, and dryness.
Patients with dry eye often have damage on the surface of the eye. In previous studies,
RGN-259 has been shown to promote healing of the surface of the eye and decrease
inflammation. It suggests that RGN-259 has a significant potential to be an important new
safe and effective therapeutic in the treatment of dry eye syndrome.

Inclusion Criteria:

- Be at least 18 years of age;

- Provide written informed consent;

- Have a subject reported history of dry eye for at least 6 months

- Have a history of use or desire to use eye drops for dry eye symptoms within 6 months

Exclusion Criteria:

- Have any clinically significant slit-lamp findings at Visit 1 that may include active
blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active
ocular allergies that require therapeutic treatment, and/or in the opinion of the
investigator may interfere with study parameters;

- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
ocular inflammation at Visit 1;

- Have ab uncontrolled systemic disease: