On 12 March 2025, Medical Dialogues reported that Intas Pharmaceuticals has received approval from India’s Subject Expert Committee functional under the Central Drug Standard Control Organisation (CDSCO) to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.
The only currently authorised ophthalmic bevacizumab is Outlook Therapeutics’ Lytenava™ (ONS-5010, bevacizumab-vikg), which received marketing authorisation in the EU in May 2024 and was approved in the UK in July 2024 following submission of a marketing authorisation application to the MHRA under the International Recognition Procedure (IRP). Outlook Therapeutics resubmitted a BLA to the US FDA for ONS-5010 in February 2025 after the FDA issued a complete response letter in 2023.