Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Inclusion Criteria:

- History of dry eye syndrome (KCS) for a period of at least 6 months

- Clinical diagnosis of bilateral KCS

- Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible
score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the
Screening and Baseline Visits.

- Global symptom score (SANDE) ≥ 40 mm at both the Screening and Baseline Visits

- Corrected Snellen visual acuity (VA) of better than 20/200 in each eye.

Exclusion Criteria:

- Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to
the Screening Visit.

- Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion
0.05% (Restasis).

- Diagnosis of Sjögren's disease ˃ 5 years prior to the Screening Visit.

- Clinical diagnosis or any history of seasonal and/or perennial allergic
conjunctivitis.

- Use of systemic or topical medications within 7 days prior to the Screening Visit or
during the study period that are known to cause dry eye.

- Use of any topical ophthalmic medications, prescription (including anti-glaucoma
medications) or over the counter (including artificial tears), other than the
assigned study medication during the study period.

- Current active eye disease other than dry wyw syndrome (i.e., any disease for which
topical or systemic ophthalmic medication is necessary).

- History of herpes keratitis.

- Corneal transplant

- Corneal refractive surgery within 6 months prior to the Screening Visit or
postoperative refractive surgery symptoms of dryness that have not resolved.

- Cataract surgery within 3 months prior to the Screening Visit.