Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP)

Exclusion Criteria

• •Any allergy to afamelanotide or the polymer contained in the implant or to lidocaine or other local anesthetic to be used during the administration of the study medication
• •EPP patients with significant hepatic involvement
• •Personal history of melanoma or dysplastic nevus syndrome.
• •Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions.
• •Any other photodermatosis such as PLE, DLE or solar urticaria.
• •Any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory determinations.
• •Acute history of drug or alcohol abuse (in the last 6 months).
• •Patient assessed as not suitable for the study in the opinion of the Investigator (e.g. noncompliance history, allergic to local anesthetics, faints when given injections or giving blood).
• •Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.
• •Prior and concomitant therapy with medications which may interfere with the objectives of the study, including drugs that cause photosensitivity or skin pigmentation within 60 days prior to the screening visit.
• •Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating.
• •Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device).