Abbvie ((ABBV)), Abbvie (($CC:ABBV.CUR)) announced an update on their ongoing clinical study.
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AbbVie, in collaboration with REGENXBIO Inc., is conducting a pivotal Phase 3 clinical study titled ‘A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD.’ The study aims to assess the efficacy and safety of RGX-314, a novel gene therapy for neovascular age-related macular degeneration (wet AMD), which is a leading cause of vision loss. This therapy could potentially offer a one-time treatment alternative to current anti-VEGF therapies, which require frequent injections.
The study is testing two doses of the RGX-314 gene therapy, delivered subretinally, against aflibercept, an existing treatment administered via intravitreal injection. The goal is to determine the change in best-corrected visual acuity as the primary endpoint.
This interventional study employs a randomized, parallel assignment model with quadruple masking to ensure unbiased results. The primary purpose is treatment, and the study involves three arms: two experimental arms for RGX-314 and one control arm for aflibercept.
The study began on January 13, 2022, and is currently recruiting participants. The last update was submitted on August 11, 2025. These dates are crucial as they indicate the study’s progress and timelines for potential results.
The outcome of this study could significantly impact AbbVie’s stock performance by potentially introducing a groundbreaking treatment for wet AMD. This could shift market dynamics, especially if RGX-314 proves to reduce the treatment burden compared to existing therapies, influencing investor sentiment positively.
The study is ongoing, with further details available on the ClinicalTrials portal.