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 × 1011 vg per eye, which is three times lower than the first cohort’s dose of 6 × 1011 vg per eye, rather than the 2 × 1012 vg per eye that the company originally had planned due to preliminary anatomical response observed in the first cohort.

A planned third cohort, which would have received a dose of 6 × 1012 vg per eye, is still on partial clinical hold, and the company does not plan to dose at this level, the release said.

“Given the encouraging robust anatomical response from patients in the first cohort, we will begin dosing patients in the second cohort at a lower dose of 2 × 1011 vg per eye, instead of dose escalating as previously planned,” Adverum CEO Leone Patterson said in the release.

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 × 1011 vg per eye, which is three times lower than the first cohort’s dose of 6 × 1011 vg per eye, rather than the 2 × 1012 vg per eye that the company originally had planned due to preliminary anatomical response observed in the first cohort.

A planned third cohort, which would have received a dose of 6 × 1012 vg per eye, is still on partial clinical hold, and the company does not plan to dose at this level, the release said.

“Given the encouraging robust anatomical response from patients in the first cohort, we will begin dosing patients in the second cohort at a lower dose of 2 × 1011 vg per eye, instead of dose escalating as previously planned,” Adverum CEO Leone Patterson said in the release.