Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

Inclusion Criteria: * Male or female ≥40 years of age * Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months; confirmation of osteoarthritis according to American College of Rheumatology Criteria (clinical and radiological) * Kellgren-Lawrence grades II or III * Mean score for the WOMAC A subscale (pain) between 2.0 and 3.5 for the index knee * Score of 2-3 for the WOMAC A1 score (pain on walking) for the index knee * Body mass index ≤ 40 kg/m2 * Willingness to abstain from use of restricted medications during the study * Willingness and ability to comply with the study procedures and visit schedule Exclusion Criteria: * Kellgren-Lawrence Grade 0, I or IV radiographic stage of the index knee * Clinically apparent tense effusion in index knee * Presence of surgical hardware or other foreign body in the index knee * Clinical signs and symptoms of active knee infection or crystal disease * Intra-articular corticosteroid within 3 months of Screening * Intra-articular hyaluronic acid within 6 months of Screening * Other intra-articular therapy within 3 months of Screening * Prior arthroscopic or open surgery of the index knee within 12 months of Screening * Planned/anticipated surgery of the index knee during the study period * History of malignancy or other serious, non-malignant, significant, acute or chronic medical (e.g.. uncontrolled diabetes) or active psychiatric illness * Skin breakdown at the knee where the injection would take place * Women who are pregnant, nursing or likely to become pregnant during the time of the study * Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year) not using effective contraception