eClinical Technology and Industy News

Adverum Biotechnologies Presents Best-Corrected Visual Acuity and Central Subfield Thickness Analyses After a Single IVT Injection of ADVM-022 (Ixo-vec) in the OPTIC Study in Wet AMD

– Study participants had an 81%-98% reduction in annualized anti-VEGF injections and demonstrated continuous aflibercept expression levels through three years

– Mean best-corrected visual acuity and central subfield thickness were maintained or improved in subjects treated with ADVM-022

-The Phase 2 LUNA trial is expected to dose the first subject in the third quarter of 2022 and preliminary data anticipated throughout 2023

Excerpt from the Press Release:

REDWOOD CITY, Calif., July 15, 2022 (GLOBE NEWSWIRE) — Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced new data from the OPTIC study treating wet age-related macular degeneration (wet AMD) during the American Society of Retina Specialists (ASRS) 2022 Annual Meeting. New data presented are as of February 24, 2022 and include best-corrected visual acuity (BCVA) and central subfield thickness (CST) maintenance, as well as reduction in CST fluctuation after a single, in-office intravitreal (IVT) injection of ADVM-022, ixoberogene soroparvovec (Ixo-vec), in subjects requiring frequent anti-VEGF injections for their wet AMD.

“We are pleased to present our findings on BCVA and CST from the OPTIC trial, establishing that maintenance in both BCVA and CST, as well as a reduction in CST fluctuations, were sustained through at least two years, suggesting the long-term durability of Ixo-vec after a single IVT injection,” stated Richard Beckman, M.D., chief medical officer at Adverum Biotechnologies. “As several publications have recently highlighted, retinal CST fluctuations over time are associated with poor long-term visual outcomes for patients. The combination of durable maintenance of BCVA and reduced CST fluctuations in subjects who previously required frequent IVT injections further support our belief that Ixo-vec can provide better long-term benefit for wet AMD patients. We are excited by the possibility of extending the treatment benefit for this lifelong disease from the order of months to the order of years.”

Data Highlights as of February 24, 2022

  • OPTIC trial participants had an 81%-98% reduction in annualized anti-VEGF injections and demonstrated continuous therapeutic aflibercept protein expression levels through three years following a single, in-office intravitreal injection of ADVM-022.
  • Mean BCVA (ETDRS) change from baseline to last visit was maintained or improved for two years post-treatment with ADVM-022 across both the 6×10^11 vg/eye (6E11) and 2×10^11 vg/eye (2E11) dose levels.
  • Mean CST was reduced by 55.7 µm at the 6E11 dose (p=0.014) and by 95.9 µm at the 2E11 dose (p=0.015) and maintained for two years following treatment across both ADVM-022 dose levels.
  • In the 2E11 dose in subjects with neutralizing antibodies (NAb) titers <1:125, subjects demonstrated a mean BCVA improvement of 5.2 letters for two years following treatment with ADVM-022.

Click the button below to read the entire Press Release:

Continue Reading The Press Release

Discover What Sets TrialStat Apart From Ordinary EDC Platforms

Click the image or button below to explore our eClinical Suite Platform and discover what sets TrialStat apart from competing EDC platforms.

Request Your Demo Today!

From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?

Archives