Adverum's Wet AMD Gene Therapy Shows Long Term Benefit In Treatment-Experienced Patients

Loading...
Loading...
  • Adverum Biotechnologies Inc ADVM has announced new long-term data from the OPTIC Phase 1 trial of ADVM-022 single intravitreal (IVT) injection gene therapy in patients with neovascular or wet age-related macular degeneration (wet AMD).
  • Safety and efficacy data from patients followed for a median of 88 and 68 weeks at 2 x 10^11 vg/eye dose (for Cohorts 2 & 3, respectively) and 104 and 36 weeks at the 6 x 10^11 vg/eye dose (for Cohorts 1 & 4, respectively). The data was presented at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Virtual Meeting.
  • ADVM-022 demonstrated durability out to two years with the ease of a single, in-office intravitreal injection.
  • Data showed that 60% (9/15) of the patients following 2 x 10^11 vg/eye dose did not require supplemental anti-VEGF injection anti-VEGF injection.
  • 73% of patients required zero or one injection following 2 x 10^11 vg/eye at one-year
  • 87% of patients were injection-free following 6 x 10^11 vg/eye dose.
  • Additionally, the aflibercept protein levels at the 2e11 dose were within the modeled therapeutic range. They sustained out to at least one year, consistent with levels observed 4-6 weeks after an aflibercept injection.
  • All ADVM-022-related ocular adverse events were mild (80%) to moderate (20%) in OPTIC patients with wet AMD. No clinical or fluorescein evidence of posterior inflammation.
  • At 2 x 10^11 vg/eye dose, ocular inflammation was minimal and responsive to steroid eye drops; 87% of patients have discontinued steroid eye drops.
  • A substantial reduction was seen in annualized anti-VEGF injection frequency following ADVM-022 in patients who previously required frequent injections.
  • On Friday, the company's share price dropped after it reported an unexpected serious adverse reaction of hypotony in the Phase 2 trial evaluating ADVM-022 in diabetic macular edema.
  • The event was reported in one patient who received a high dose of (6 x 10^11 vg/eye).
  • Price Action: ADVM shares are up 6.2% at $4.14 during the premarket session on the last check Monday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsPenny StocksHealth CareSmall CapGeneralBriefsgene therapyWet AMD
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...