Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA

This is a randomized, open label, parallel group study that will be conducted in male and
female patients ≥ 40 years of age with bilateral knee OA.

Approximately 24 patients will be randomized to one of two treatment groups (1:1) and treated
with IA injections to both knees of either:

- extended-release FX006 64 mg total dose (approximately 12 patients) or

- immediate-release TAcs 80 mg total dose (approximately 12 patients) Each patient will be
screened to confirm the diagnosis of OA and eligibility based on the inclusion/exclusion
requirements and will be randomized to treatment on Day 1. Following screening,
pharmacokinetics (PK) and safety will be evaluated at 6 out-patient visits scheduled on
Study Days 1 [calendar day of injection], 2, 8, 15, 29, and 43.

Inclusion Criteria:

- Written consent to participate in the study

- Male or female greater than or equal to 40 years of age

- Symptoms consistent with OA in both knees for greater than or equal to 6 months prior
to Screening (patient reported is acceptable)

- Currently meets ACR Criteria (clinical and radiological) for OA in both knees

- Knee pain in both knees for greater than 15 days over the last month (as reported by
the patient)

- Body mass index (BMI) less than or equal to 40 kg/m2

- Morning serum cortisol result within normal range at Screening (5-23 mcg/dL or 138-635
nmol/dL)

- Ambulatory and in good general health

- Willing and able to comply with the study procedures and visit schedules and able to
follow verbal and written instructions.

- Willing to abstain from use of protocol-restricted medications during the study

Exclusion Criteria:

- Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis,
or arthritis associated with inflammatory bowel disease

- History of infection in either knee joint

- Clinical signs and symptoms of active knee infection or crystal disease in either knee
within 1 month of Screening

- Unstable joint (such as a torn anterior cruciate ligament) in either knee within 12
months of Screening

- Presence of surgical hardware or other foreign body in either knee

- Surgery or arthroscopy of either knee within 12 months of Screening

- IA treatment of any joint with any of the following agents within six (6) months of
Screening: any corticosteroid preparation (investigational or marketed, including
FX006), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells,
prolotherapy, amniotic fluid injection; investigational or marketed).

- IA treatment in either knee with hyaluronic acid (investigational or marketed) within
6 months of Screening

- Parenteral or oral corticosteroids (investigational or marketed) within 3 months of
Screening

- Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2
weeks of Screening

- Females who are pregnant or nursing or plan to become pregnant during the study; men
who plan to conceive during the study