FDA partially lifts clinical hold for Adverum’s wet AMD gene therapy

The FDA has partially lifted the clinical hold on Adverum Biotechnologies’ wet age-related macular degeneration gene therapy treatment candidate ADVM-022, allowing a phase 1 trial to continue, the company announced in a press release.
The second cohort of the OPTIC trial will now receive a dose of 2 × 10 vg per eye, which is three times lower than the first cohort’s dose of 6 × 10 vg per eye, rather than the 2 × 10 vg per eye that the company originally had planned due to preliminary anatomical response (Read more...)

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