“Clinical and regulatory goals”
CLINUVEL’s senior management in regulatory affairs and clinical research discuss the development of CLINUVEL’s proprietary first-in-class drug, SCENESSE® (afamelanotide).
Administered by physicians as a controlled-release resorbable implant, SCENESSE® is a preventative drug activating melanin – pigmentation – in the skin.
Melanin provides a biological barrier, protecting skin from UV and visible light. Medically, this is known as photoprotection.
SCENESSE® is released over 10 days by the implant, while activating melanin for up to 60 days. The breakthrough controlled-release formulation maximizes the effect of the drug, while minimizing patient exposure to drug substance.
CLINUVEL’s ongoing clinical program aims to demonstrate the safety and efficacy of SCENESSE® as a medicinal photoprotective drug.