AbbVie to Earn $100M Milestone as NAVIGATE DR Trial Begins Dosing
AbbVie will receive a $100 million milestone payment next quarter when the NAVIGATE DR trial for RGX-314 begins dosing diabetic retinopathy patients. Top-line readouts for wet AMD from the ATMOSPHERE and ASCENT pivotal studies are scheduled in Q4 2026, advancing AbbVie’s gene therapy pipeline.
1. Ophthalmology Collaboration with REGENXBIO
AbbVie’s partnership on RGX-314 targets both wet age-related macular degeneration and diabetic retinopathy, using subretinal delivery for AMD and suprachoroidal delivery for DR to reduce anti-VEGF injection frequency and broaden the company’s gene therapy portfolio.
2. NAVIGATE DR Trial Dosing and $100M Milestone
The double-masked, sham-controlled NAVIGATE DR trial is set to dose its first patient next quarter, which will trigger a $100 million milestone payment to AbbVie under the collaboration agreement.
3. Wet AMD Pivotal Study Timeline
The ATMOSPHERE and ASCENT Phase III pivotal studies for wet AMD are slated to report top-line data in Q4 2026, supported by Phase I/II bilateral dosing results showing a 93% reduction in annualized anti-VEGF injections at 12 months and 60% of patients remaining injection-free.
4. Strategic and Financial Implications
The upcoming milestone payment and pivotal readouts reinforce AbbVie’s commitment to innovative ophthalmology programs, potentially boosting near-term revenue recognition and enhancing long-term value in the gene therapy pipeline.