Repository Corticotropin Injection in Keratoconjunctivitis Sicca

This study is a non-randomized, open-label, interventional pilot study with sixteen weeks
(112 days) of active treatment, a possible twelve-week treatment extension, and twenty-four
weeks of washout follow-up. Intervention is with HP Acthar Gel dosed at 80 U BIW SC indicated
for use in anterior segment disease and keratitis. Data will be collected from five subjects.
All subjects will be treated with 80 U BIW SC and clinically examined at two, four, six,
nine, twelve, and sixteen weeks with a potential extension of up to twenty-eight weeks.
Extension will be contingent upon specific outcome criteria defined in this protocol. Four
clinical visits will occur at two, four, eight, and twelve weeks after initiating the drug
taper to assess for regression of the signs and symptoms of KCS.

Inclusion Criteria:

- Age ≥ 18 years

- Severe keratoconjunctivitis sicca (KCS) as defined by meeting at least three of the
following in the same or both eye(s): (1) OSDI ≥ 33, (2) sum corneal staining with
fluorescein of ≥ 5 in at least one eye, (3) MMP-9 concentration ≥ 40 ng/ml in at least
one eye as measured by InflammaDry®, and (4) bulbar hyperemia of ≥ 2.0 in at least one
eye as measured by the Oculus Keratograph® 5M

- Recalcitrant or intolerant to treatment with cyclosporine 0.05% ophthalmic emulsion
(Restasis®) or lifitegrast 5% ophthalmic solution (Xiidra®)

Exclusion Criteria:

- Past or present history of: scleroderma, osteoporosis, systemic bacterial or fungal
infection (including but not limited to tuberculosis), psychosis, ocular herpes
simplex, peptic ulcer, congestive heart failure, diabetes mellitus, myasthenia gravis,
hypothyroidism, liver cirrhosis, primary adrenocortical insufficiency or
adrenocortical hyperfunction, central serous chorioretinopathy.

- Any corticosteroid use within 60 days of study enrollment

- Topical cyclosporine 0.05% ophthalmic emulsion (Restasis) or lifitegrast 5% ophthalmic
solution (Xiidra) use within 60 days of study enrollment

- Recent surgery within 90 days

- Current uncontrolled, sustained hypertension

- Post-prandial blood glucose value of ≥ 140 mg/dl as measured at the baseline visit

- Sensitivity to proteins of porcine origin

- Anticipated administration of live or live attenuated vaccines during the course of
the study

- Known sensitivity to steroid or complications from prior steroid use that subject is
unwilling to tolerate

- Pregnancy (as assessed by urine hCG) or nursing

- Participation in a clinical trial involving a drug or device within the past 30 days

- Investigator discretion based upon medical history and/or opinion of ability to
maintain protocol compliance