Orphan drug designation would entitle Fovea to exclusive marketing rights in the European countries for 10 years should Fovea be the first company to receive marketing approval for this type of therapeutic drug product. In addition, the designation would allow Fovea to apply for research funding, tax credits for certain research expenses and protocol assistance.
Bernard Gilly, chairman and CEO of Fovea, said: “We are pleased to have received this orphan drug designation for RdCVF in the treatment of retinitis pigmentosa. This designation is a recognition of the quality of our work and will also provide us with financial and regulatory benefits in addition to market exclusivity.”