Scenesse is a subcutaneous implant designed to increase pain-free light exposure in this rare patient population. The implant increases the production of eumelanin in the skin independent of exposure to sunlight or artificial light.
The approval of Scenesse was based on data from two parallel-group clinical trials of patients with erythropoietic protoporphyria who received Scenesse or placebo subcutaneously every two months. In the first clinical trial of 93 patients, 48 received Scenesse. Patients receiving Scenesse spent a median of 64 hours in direct sunlight with no pain during 10 a.m. to 6 p.m. over 180 days compared with a median of 41 hours for patients who received placebo. In the second trial of 74 patients, 38 received Scenesse.
This trial did not include sun exposure on days when patients reported spending time in both direct sunlight and shade. Patients receiving Scenesse reported spending a median of six hours outdoors pain-free between 10 a.m. and 3 p.m. when "most of the day" was spent in direct sunlight over 270 days compared with 0.75 hours reported by patients who received placebo.
The most commonly reported side effects of Scenesse are implant site reaction, nausea, oropharyngeal pain, cough, fatigue, skin hyperpigmentation, dizziness, melanocytic nevus, respiratory tract infection, somnolence, nonacute porphyria, and skin irritation.
The FDA notes that Scenesse should be administered by a health care professional proficient in the procedure for subcutaneous implantation and who has completed the applicant-provided training. Patients are recommended to undergo a full-body skin examination twice a year and are encouraged to maintain sun protection measures during treatment.
Approval was granted to Clinuvel.