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AbbVie, REGENXBIO Enter Eye Care Collaboration

Strategic partnership combines eye care and gene therapy expertise.

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By: Kristin Brooks

Managing Editor, Contract Pharma

AbbVie and REGENXBIO Inc. entered a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases. RGX-314 is currently being evaluated in patients with wet AMD in a pivotal trial utilizing subretinal delivery, and in patients with wet AMD and DR in two separate Phase II clinical trials using in-office suprachoroidal delivery.
 
REGENXBIO will be responsible for completion of the ongoing trials of RGX-314. AbbVie and REGENXBIO will collaborate and share costs on additional trials of RGX-314. AbbVie will lead the clinical development and commercialization of RGX-314 globally. REGENXBIO will participate in U.S. commercialization efforts under a mutually agreed plan.
 
REGENXBIO will receive $370 million upfront with the potential for up to $1.38 billion in additional development, regulatory and commercial milestones. The companies will share profits from sales of RGX-314 in the U.S. equally. AbbVie will also pay royalties on sales of RGX-314 outside the U.S. In addition, REGENXBIO will lead the manufacturing of RGX-314 for clinical development and U.S. commercial supply, and AbbVie will lead manufacturing of RGX-314 for commercial supply outside the U.S. 
 
The transaction is expected to close by the end of 2021, subject to the satisfaction of customary closing conditions, including applicable regulatory approvals.

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