5 Key Takeaways
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1
Axpaxli outperformed an FDA-approved anti-VEGF therapy in the phase 3 SOL-1 trial for wet age-related macular degeneration.
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2
The drug is a bioresorbable hydrogel containing axitinib, a tyrosine kinase inhibitor with antiangiogenic properties.
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3
SOL-1 is the first superiority trial in the field to succeed, potentially leading to the first superiority label for a wet AMD treatment.
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4
Ocular Therapeutix plans to file for approval based solely on the SOL-1 trial results, following FDA guidelines and receiving a special protocol agreement.
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5
The ongoing SOL-R trial will provide additional information but is not deemed necessary for Axpaxli's approval.
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