Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1

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

- Have a Schirmer's Test score of ≤10mm and ≥1mm

- Have a Tear Film Break-Up Time (TFBUT) ≤10 seconds

- Have a corneal fluorescein staining score of ≥2 in at least one region of the cornea

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 worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses
during the study;

- Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the
last 6 months;

- Have an IOP > 25 mmHg at Visit 1;

- Have any planned ocular and/or lid surgeries over the study period;

- Be using or anticipate using temporary punctal plugs during the study that have not
been stable within 30 days of Visit 1;

- Be currently taking any topical ophthalmic prescription (including medications for
glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and
cannot discontinue these medications for the duration of the trial (excluding
medications allowed for the conduct of the study);

- Have corrected visual acuity greater than or equal to logMAR +0.7 as assessed by Early
Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1;