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EyePoint's Duravyu misses wet AMD primary endpoint, hinges on second trial for FDA path
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Fusion42 · 17 August 2026 · Fusion42 review
EyePoint Pharmaceuticals reported that its Duravyu Phase III trial for wet AMD missed the primary endpoint of visual acuity non-inferiority to aflibercept, relying on a second Phase III trial, LUCIA, for FDA approval. Despite this, Duravyu showed significant treatment burden reduction and safety benefits, with LUCIA results expected in Q4 2026 guiding the regulatory path.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
You face a delayed FDA approval in wet AMD treatment as Duravyu's trial missed key endpoints but still offers a treatment advantage. This shift calls for contingency plans until the second pivotal trial provides the regulatory path forward.
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1 source · 17 Aug 2026
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