Outlook Therapeutics Receives UK Approval of Lytenava for Wet AMD Treatment
Outlook Therapeutics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Lytenava (bevacizumab gamma) for the treatment of wet age-related macular degeneration (AMD) in the UK.
Lytenava is the first and only authorized ophthalmic formulation of bevacizumab approved for use in treating wet AMD in both the EU and UK.
Endorsement from Clinical Experts
“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," commented Professor Tim Jackson, PhD, FRCOphth, Consultant Ophthalmic Surgeon at King's College Hospital and Professor of Retinal Research at King’s College London.
"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.”
Regulatory Pathway and Approval Process
The approval by the MHRA follows a recent Marketing Authorization granted by the European Commission for Lytenava, facilitated through the International Recognition Procedure (IRP). This procedure allows the MHRA to rely on the positive opinion of the European Medicines Agency’s CHMP regarding marketing authorization for the same product in the EU.
“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," said Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. "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.”
Strategic Collaboration and Future Prospects
As part of its strategic planning, Outlook Therapeutics has entered into a collaboration with Cencora (formerly AmerisourceBergen) to support the global commercial launch of Lytenava. This partnership aims to ensure efficient distribution and accessibility of the treatment.
In the United States, Lytenava (marketed as ONS-5010) remains investigational and is currently undergoing evaluation in a non-inferiority study for the treatment of wet AMD.
The approval of Lytenava by the MHRA represents a significant advancement in Outlook Therapeutics’ mission to address unmet medical needs in ophthalmology, particularly in the management of wet AMD. With preparations underway for commercial availability in the EU and UK, the company anticipates providing a vital treatment option to patients and healthcare providers in early 2025.
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