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- 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.
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ADVMAdverum Biotechnologies Inc
$2.59-4.78%
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