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Adverum Biotechnologies (ADVM -9.8%) has announced positive new interim data from Cohorts 1-4 of the OPTIC Phase 1 trial of ADVM-022 intravitreal injection gene therapy in patients with wet age-related macular degeneration, who require frequent anti-VEGF injections.Data showed treatment response from both high and low doses of ADVM-022, and demonstrated long-term durability beyond 15 months from a single IVT injection with zero anti-VEGF rescue injections in patients from Cohort 1.On safety front, ADVM-022 was well tolerated across all cohorts with encouraging safety data from Cohort 4; though ocular inflammation was observed that was responsive to steroid eye drops.With the OPTIC enrollment now complete, the company expects to present clinical data from Cohorts 1 to 4 by the end of this year.It plans to initiate a pivotal Phase 3 clinical trial in mid-2021, a timeline that investors may be reacting to.The company has initiated process scale-up from 200L to 1000L scale to support the future commercial product launch of ADVM-022.Also, expects to present clinical data from INFINITY Phase 2 data of ADVM-022 in diabetic macular edema in 2H of 2021.
From Talk Markets