Efficacy and Safety of H.P. Acthar® Gel in Subjects With Severe Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis NIPPU

1. Participants must be adequately informed and understand the nature and risks of the
study and must be able to provide a signature and date on the ICF.

2. Participants must be ≥ 18 years of age at Screening Visit and can be male or female.

3. Participants must have been diagnosed with current severe NIPPU and have active
disease at the Baseline Visit as defined by the presence of at least 1 of the
following parameters in at least one eye despite at least 2 weeks of maintenance
therapy with oral prednisone 10 mg/day to ≤ 60 mg/day (or oral corticosteroid
equivalent): Active, inflammatory, horioretinal and/or inflammatory retinal vascular
lesion. ≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN]
criteria). ≥ 2+ vitreous haze (Nussenblatt et al, 1985).

4. Participants entering the study on 1 concomitant immunosuppressive therapy must not
have had the dose increased in the 2 weeks prior to the Baseline Visit and must be
within the following allowable doses at the Baseline Visit:

- Methotrexate ≤ 15 mg per week.

- Cyclosporin ≤ 4 mg/kg per day.

- Mycophenolate mofetil ≤ 2 g per day or an equivalent drug (eg, mycophenolic acid)
at an equivalent dose that has been approved by the medical monitor (MM).

- Azathioprine ≤ 175 mg per day.

- Tacrolimus (oral formulation) ≤ 8 mg per day.

- Adalimumab 40 mg SC every other week.

5. Participants must be willing to taper their current doses of corticosteroid and
immunomodulatory therapy to the minimum effective dose during the study.

6. Female Participants must be of nonchildbearing potential (history of hysterectomy,
bilateral oophorectomy, or bilateral tubal ligation; or postmenopausal with no history
of menstrual flow in the 12 months prior to the Screening Visit); or if of
childbearing potential must be nonpregnant, nonlactating and agree to use effective
contraception when with a male partner throughout study participation (through the
Follow-up Visit). Acceptable forms of contraception include hormonal measures (oral
contraceptive pills, contraceptive patch, contraceptive ring, injections),
intrauterine devices, double barrier method (condom plus diaphragm, condom or
diaphragm plus spermicidal gel or foam), and abstinence.

Exclusion Criteria:

1. Participant is from a vulnerable population, as defined by the US CFR Title 45, Part
46, Section 46.111(b) and other local and national regulations, including but not
limited to, employees (temporary, part-time, full time, etc) or a family member of the
research staff conducting the study, or of the sponsor, or of the clinical research
organization, or of the IRB/IEC.

2. Participant has a history of sensitivity to ACTH preparations or sensitivity to
porcine protein products.

3. Participant has had recent (within the previous 6 months) diabetic retinopathy,
age-related macular degeneration, intraocular surgery or ocular trauma, cataracts, or
posterior capsule opacification.

4. Participant is under treatment with any corticosteroids, immunosuppressants,
immunomodulators, or biologic agents for a concomitant condition (eg, rheumatoid
arthritis under treatment with a tumor necrosis factor- alpha [TNF-α] drug).
Participants are specifically excluded for any of the following:

5. Participant has received (glucocorticosteroid implant) within 3 years prior to the
Baseline Visit or has had complications related to the device and/or Participant has
had removal within 90 days prior to the Baseline Visit or has had complications
related to the removal of the device.

6. Participant has received intraocular or periocular corticosteroids within 30 days
prior to Baseline Visit.

7. Participant has proliferative or severe nonproliferative diabetic retinopathy or
clinically significant macular edema due to diabetic retinopathy.

8. Participant has neovascular/wet age-related macular degeneration.

9. Participant has an abnormality of a vitreoretinal interface (ie, vitreomacular
traction, epiretinal membranes, etc) with the potential for macular structural damage
independent of the inflammatory process.

10. Participant has a severe vitreous haze that precludes visualization of the fundus at
the Baseline Visit.

11. Participant has any known contraindication(s) to Acthar (Mallinckrodt Package Insert,
2018) including, but not limited to: Any known history of scleroderma, osteoporosis,
or ocular herpes simplex. For the purposes of this study, osteoporosis is defined as
evidence of current vertebral or long bone fracture, or lumbar T-score > 2.0 SD below
the mean of the reference population.

12. Any primary adrenocortical insufficiency, or adrenal cortical hyperfunction.

13. Any current congestive heart failure (defined as New York Heart Association

14. Participant has a history of chronic active hepatitis including active or chronic
hepatitis B, or acute or chronic hepatitis C.

15. Participant has a history of tuberculosis (TB) infection, any signs/symptoms of TB, or
any close contact with an individual with an active TB infection.

16. Participant has known immune compromised status (not related to disease/condition
under study), including but not limited to, individuals who have undergone organ
transplantation or who are known to be positive for the human immunodeficiency virus.

17. Participant has any solid tumor malignancy currently diagnosed or undergoing therapy,
or has received therapy for any solid tumor malignancy in the 5 years prior to the
Screening Visit; with the exception of treated and cured basal cell carcinoma, treated
and cured squamous cell carcinoma of the skin, and treated and cured carcinoma in situ
of the cervix.

18. Participant has any of the following laboratory abnormalities at the Screening Visit:
Hemoglobin ≤ 8.0 g/dL. Platelets ≤ 50,000 cells/μL. Absolute neutrophil count (ANC) ≤
1000 cells/μL. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or
total bilirubin 2 times upper limit of normal (ULN).

19. Glycosylated hemoglobin (HbA1c) 6.5. Positive Hepatitis B surface antigen (HBsAg) or
Hepatitis B core antibody (HBcAb), or positive Hepatitis C virus antibody (HCV). (If
HCV is positive at screening, HCV polymerase chain reaction [PCR] will be
automatically analyzed. Participants with a positive HCV must have HCV PCR < 25 IU/mL
at the Screening Visit to be eligible).

20. Participant has any other clinically significant disease, disorder or laboratory
abnormality (including those listed on the Prescribing Information Section 5: Warnings
and Precautions [Mallinckrodt Package Insert, 2018]) which, in the opinion of the
investigator (by its nature or by being inadequately controlled), might put the
patient at risk due to participation in the study, or may influence the results of the
study or the Participant's ability to complete the study.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply