Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease

This is a Phase 2, multi-center, Investigator-masked, randomized, parallel-group study to
evaluate the tolerability, efficacy and safety of VOS versus Restasis® over a 28-day
treatment period in subjects with mild to moderate DED. Approximately 90 subjects will be
randomized to either VOS or Restasis® at approximately 7 centers located in the US

Inclusion Criteria:

1. Have a best corrected visual acuity (BCVA) in both eyes of +0.7 logarithm of the
Minimum Angle of Resolution (logMAR) or better as assessed by Early Treatment of
Diabetic Retinopathy Study (ETDRS) chart.

2. Have a documented history of DED in both eyes supported by a previous clinical
diagnosis.

3. Have ongoing DED, as defined by at least one eye (if one eye, the same eye) meeting
all the following criteria:

- A symptom severity score of ≥30 for Eye Dryness on a Visual Analog Scale (VAS)
(0-100)

- An unanesthetized Schirmer Tear Test (STT) score of ≥1 mm and ≤10 mm per 5
minutes (Note: STT Score obtained at Visit 1)

- Evidence of ocular surface staining (total fluorescein staining score of at least
3 [0-15 scale]).

4. Have normal lid anatomy.

Exclusion Criteria:

1. Have any known hypersensitivity or contraindication to study treatments (including
excipients), topical anesthetics or vital dyes.

2. Be unable to demonstrate correct instillation of over-the-counter (OTC) ocular
lubricant.

3. Report discomfort in both eyes from instillation of OTC ocular lubricant during Visit
2 (based on score of ≥30 on the Drop Discomfort VAS).

4. Have used Restasis® (cyclosporine ophthalmic emulsion) within 30 days prior to Visit
1.

5. Have used Restasis® for more than 1 month (if prior use is reported).

6. Have used Xiidra® (lifitegrast ophthalmic solution) within 14 days prior to Visit 1.

7. Have had corneal graft surgery in either eye within 1 year.

8. Have recent or current evidence of ocular infection or inflammation in either eye.

9. Have current evidence of clinically significant blepharitis (defined as requiring lid
hygiene therapy), conjunctivitis, or a history of herpes simplex or zoster keratitis
in either eye.