A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)

Inclusion criteria

• male or female subjects with a positive diagnosis of EPP who successfully completed the CUV017 or CUV029 studies;
• aged 18-75 years (inclusive);
• provide written informed patient consent prior to the performance of any study-specific procedure.

Exclusion criteria

• any serious adverse event considered to be related to afamelanotide or the polymer contained in the implant;
• any allergy to lignocaine or other local anaesthetic 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 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 12 months);
• female who is pregnant (confirmed by positive serum β-Human Chorionic Gonadotropin (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);
• sexually active men with partners of child-bearing potential not using barrier contraception during the trial and for a period of three months thereafter;
• 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.