The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to Adverum Biotechnologies’ (NASDAQ:ADVM) lead drug ADVM-022 for the treatment of wet age-related macular degeneration (wet AMD).
A Phase 2 study in wet AMD is planned to investigate ADVM-022, expects dosing the first patient in the third quarter of 2022.
Laurent Fischer, M.D., president and chief executive officer, said, “We are extremely pleased with EMA's decision to grant ADVM-022 PRIME designation. Following the encouraging results seen in the OPTIC trial in wet AMD, our PRIME designation recognizes the broad potential of ADVM-022 and is based in part on our trial subjects now having three-year sustained aflibercept expression with stable disease and maintained long-term central subfield thickness and visual acuity after a single IVT injection.”
PRIME is a program launched by the EMA to enhance support for research on and development of medicines that target a significant unmet medical need.
Adverum Shares are trading higher 2 percent at $1.11
