The Scottish Medicines Consortium (SMC) has accepted Outlook Therapeutics’ Lytenava (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD) within the National Health Service Scotland (NHS Scotland).
Lytenava is the first and only licensed bevacizumab ophthalmic formulation for wet AMD in adults in the UK. It has an initial ten years of market exclusivity following its initial authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA).
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The acceptance follows the company’s announcement of its commercial availability in the UK.
The endorsement for Lytenava’s use was based on outcomes from the company’s clinical programme for the therapy.
Outlook Therapeutics Europe head and senior vice-president Jedd Comiskey stated: “Receiving the SMC recommendation of Lytenava (bevacizumab gamma) for patients with wet AMD is a significant milestone for our company and a testament to our commitment to improving patient outcomes.
“This acceptance will allow patients in Scotland to have access to an additional important treatment option. Our focus now is to work closely with healthcare providers to ensure a smooth rollout and to continue our mission of advancing healthcare solutions that make a real difference in people’s lives.”
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By GlobalDataThe company has also entered a strategic partnership with Cencora to support the worldwide commercial launch of Lytenava post-regulatory clearances.
In the US, the therapy remains investigational, while certain member states of the European Union (EU) require pricing and reimbursement approval before commencing sales
Bevacizumab-vikg (known as bevacizumab gamma in the UK and the EU) is a recombinant humanised monoclonal antibody that attaches with high affinity to all isoforms of human vascular endothelial growth factor, neutralising its biological activity.
