In a major step forward for ophthalmic care, Scotland has officially approved the first licensed formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD). The Scottish Medicines Consortium (SMC) has given the green light to Lytenava (bevacizumab gamma), developed by Outlook Therapeutics, marking a significant development for patients at risk of permanent vision loss.
A Game-Changer for Wet AMD Treatment
Lytenava is the first and only licensed ophthalmic version of bevacizumab approved for wet AMD use in both the European Union and the United Kingdom. While bevacizumab has long been used off-label in ophthalmology, this is the first time a formulation specifically designed and tested for eye conditions has received full regulatory endorsement.
“This approval ensures that patients in Scotland will have access to an additional treatment option,” said Jedd Comiskey, Senior Vice President and Head of Europe at Outlook Therapeutics. “Our focus now is to work closely with healthcare providers to ensure a smooth rollout and to continue our mission of advancing healthcare solutions.”
Scientific Rigor Behind the Green Light
The SMC’s decision was informed by Outlook’s comprehensive AMD clinical programme, which includes three clinical trials, along with supporting studies and peer-reviewed literature. These trials helped demonstrate both the safety and efficacy of Lytenava in managing wet AMD — a condition that can lead to rapid and irreversible vision loss if left untreated.
Wet AMD affects the macula — the central part of the retina — and is caused by the growth of abnormal blood vessels beneath it. These vessels leak fluid and blood, damaging nearby retinal cells and ultimately impairing central vision.
Why It Matters
Until now, patients in Scotland largely relied on off-label use of unlicensed bevacizumab, often prepared in hospital pharmacies for intravitreal injection. The approval of Lytenava offers a regulated, quality-controlled, ophthalmology-specific product, reducing variability and improving safety assurance.
It also aligns Scotland’s treatment options with wider European and UK standards, where demand for more ophthalmic-specific biologics is growing — particularly as the population ages.
Strategic Rollout with Global Backing
To ensure effective distribution, Outlook Therapeutics has formed a strategic partnership with Cencora (formerly AmerisourceBergen), a global pharmaceutical solutions provider based in the US. The collaboration will support logistics, accessibility, and outreach for healthcare professionals across the UK.
Cencora is expected to play a key role in streamlining Lytenava’s commercial launch, which began in parts of the UK earlier this month.
What’s Next?
With Scottish approval secured and UK access underway, Outlook now has its sights set on the US market, where Lytenava is not yet approved. Regulatory submissions and review processes are expected to follow later this year.
In the meantime, the company is engaging closely with NHS Scotland, clinical commissioning groups, and retinal specialists to embed the new treatment option into patient care pathways.
Table: Key Facts About Lytenava in Scotland
| Feature | Details |
|---|---|
| Drug Name | Lytenava (bevacizumab gamma) |
| Indication | Wet Age-Related Macular Degeneration (wet AMD) |
| Developer | Outlook Therapeutics |
| Approval Body | Scottish Medicines Consortium (SMC) |
| Formulation | First and only licensed ophthalmic bevacizumab in EU/UK |
| Commercial Partner | Cencora (formerly AmerisourceBergen) |
| Launch Status | Commercially available in UK as of early June 2025 |
| Next Target Market | United States |
Lytenava’s approval marks a new chapter in AMD treatment in Scotland — one backed by clinical evidence, regulatory confidence, and strategic foresight. For thousands of Scots living with or at risk of wet AMD, this represents a critical new option to help preserve vision and independence.
