Outlook Therapeutics Receives UK Approval of Lytenava for the Treatment of Wet AMD
Outlook Therapeutics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Lytenava (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet AMD. Lytenava is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU and UK.
“We have waited a long time for a brand of bevacizumab that is authorized for eye use, and it is good news that Lytenava has now entered the market. This occurs subsequent to Outlook Therapeutic's clinical trial meeting its endpoint," Professor Tim Jackson, PhD, FRCOphth, Consultant Ophthalmic Surgeon, King's College Hospital and Professor of Retinal Research, King’s College London, said in a company news release. "To date, many ophthalmologists have been hesitant to use an off-label bevacizumab, when licensed products are available. We value being able to utilize products that meet the standards required for marketing authorization. Additionally, a well-controlled pharmaceutical manufacturing operation will allay concerns that compounding pharmacies increase the risk of rare but potentially devastating endophthalmitis.”
This approval comes after Outlook Therapeutics was recently granted Marketing Authorization for Lytenava by the European Commission for the same indication. The Marketing Authorization Application (MAA) submission to the MHRA was completed under the new International Recognition Procedure (IRP), which allows the MHRA to rely on a positive opinion by the European Medicines Agency’s CHMP concerning an application for granting marketing authorization for the same product in the EU in the MHRA’s authorization decision.
“We are pleased to receive UK approval on the heels of marketing authorization in the EU for Lytenava. This milestone achievement is the final regulatory step towards our expected commercial launch in the EU and UK in the first calendar quarter of 2025. Our team continues to make a concerted effort to bring to the UK market the first and only authorized ophthalmic bevacizumab for the treatment of wet AMD. We are grateful to all the patients, researchers, clinical sites and the MHRA for the research, drug development, and regulatory efforts that led to this approval,” said Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics.
As part of a multi-year planning process, Outlook Therapeutics entered a strategic collaboration with Cencora (formerly AmerisourceBergen) to support the commercial launch of Lytenava globally.
In the United States, ONS-5010/Lytenava (bevacizumab-vikg) is investigational and is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD.