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AbbVie's $370M upfront for co-exclusive US rights to REGENXBIO's RGX-314 gene therapy is tracking toward proof: the ATMOSPHERE and ASCENT wet AMD trials finished enrolling over 1,200 patients by October 2025, though the parties amended the original $1.38B milestone structure in August 2025, swapping out a prior $200M milestone.
Outcome grade pending — assessed 5 years post-close.
Full analysis, sources & comparables →Wet AMD affects an estimated 1.5 to 2 million Americans with roughly 200,000 new cases diagnosed each year. Anti-VEGF therapy with ranibizumab, aflibercept,…
AbbVie said it would pay REGENXBIO $370 million upfront and up to $1.38 billion in additional payments for rights to develop and commercialize RGX-314, a gene…
REGENXBIO announced (Oct 6, 2025) completion of enrollment in the ATMOSPHERE and ASCENT pivotal trials of subretinal surabgene lomparvovec (sura-vec,…
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AbbVie and REGENXBIO entered a global eye care collaboration to develop and commercialize RGX-314 (now ABBV-RGX-314 / surabgene lomparvovec, "sura-vec"), a one-time AAV8 gene therapy expressing an anti-VEGF antibody fragment, for wet AMD, diabetic retinopathy and other chronic retinal diseases. Announced September 13, 2021 and closed November 9, 2021, REGENXBIO received $370M upfront and is eligible for up to $1.38B in development, regulatory and commercial milestones, with 50/50 US profit sharing and tiered ex-US royalties; AbbVie leads global development and commercialization. Post-close the program has advanced materially: the wet AMD pivotal trials ATMOSPHERE and ASCENT completed enrollment (Oct 2025, >1,200 patients, the largest gene-therapy program in nAMD to date) with topline data expected in 2026. On August 5, 2025 the parties amended the agreement — in lieu of a prior $200M milestone, AbbVie will pay REGENXBIO $100M on first patient dosed in the suprachoroidal DR Phase IIb/III trial and a further $100M on first patient dosed in a subsequent Phase III trial, while AbbVie independently funds a new wet AMD Phase III trial (ACHIEVE).
200K US cases/yr · $9.0B US wet AMD anti-VEGF market 2021 (USD MM) · 7 Average real-world anti-VEGF injections per year vs 12 mandated in trials
Wet (neovascular) age-related macular degeneration is the leading cause of irreversible vision loss in adults aged 50+ in the United States, affecting approximately 1.5 to 2 million Americans with an estimated 200,000 incident cases each year. The disease is driven by pathologic choroidal neovascularization secondary to VEGF-A overexpression in the retinal pigment epithelium, producing subretinal fluid, hemorrhage, and progressive central vision loss. Standard of care since 2006 has been intravitreal anti-VEGF injections — Lucentis (ranibizumab, Genentech/Roche), Eylea (aflibercept, Regeneron/Bayer), bevacizumab off-label, brolucizumab (Beovu, Novartis 2019), and faricimab (Vabysmo, Roche 2022) — administered every 4 to 12 weeks for life. Real-world undertreatment (driven by injection burden, transportation, and cost) produces vision outcomes substantially worse than registrational trials, with patients receiving on average 7 injections in year 1 versus the 12 mandated in PIER/MARINA studies. The total US wet AMD anti-VEGF market exceeds $9 billion and the broader retinal anti-VEGF franchise (wet AMD + DME + DR + RVO) is approximately $14-16 billion globally, creating a clear clinical and commercial opening for a one-time durable gene therapy that obviates chronic dosing.
The wet AMD competitive landscape spans entrenched anti-VEGF biologics, longer-acting reformulations, biosimilars, and emerging gene therapies. Anti-VEGF mAbs/Fc fusions: Lucentis (ranibizumab, Roche/Novartis, anti-VEGF-A Fab), Eylea (aflibercept, VEGF Trap Fc fusion, Regeneron/Bayer — 8mg HD-Eylea filed 2022), Beovu (brolucizumab, single-chain Fv, Novartis), Vabysmo (faricimab, bispecific anti-VEGF-A/anti-Ang2, Roche). Sustained-release platforms: Susvimo (ranibizumab port delivery system, Roche, approved Oct 2021), Ocular Therapeutix OTX-TKI (axitinib hydrogel implant), EyePoint Pharmaceuticals EYP-1901 (vorolanib insert), Clearside CLS-AX, Kodiak KSI-301 (anti-VEGF biopolymer conjugate). Gene therapies: REGENXBIO/AbbVie RGX-314 (AAV8-anti-VEGF Fab, subretinal and suprachoroidal routes, Phase 2/3 ATMOSPHERE/ASCENT), Adverum ADVM-022 (intravitreal AAV.7m8-aflibercept, Phase 2 — paused 2021 after hypotony AE in DME cohort), 4D Molecular Therapeutics 4D-150 (AAV intravitreal, Phase 2 SPECTRA), Janssen/Hemera JNJ-1887. Biosimilars: Byooviz (ranibizumab-nuna, Samsung Bioepis/Biogen, FDA Sept 2021), Cimerli (Coherus, FDA 2022). RGX-314 differentiates on subretinal one-time delivery with potential decade-long durability and a less-invasive suprachoroidal route enabling repeat outpatient dosing.
The AbbVie/REGENXBIO eye care Collaboration and License Agreement for RGX-314 closed on November 9, 2021. REGENXBIO received $370M upfront with up to $1.38B in milestones, 50/50 US profit share and tiered ex-US royalties; AbbVie leads global development and commercialization.
AbbVie and REGENXBIO confirmed pivotal ATMOSPHERE/ASCENT wet AMD data expected in 2026 and advancement of a suprachoroidal Phase 3 program in diabetic retinopathy. The asset received its INN, surabgene lomparvovec (sura-vec).
The parties amended the agreement (effective Aug 5, 2025). In lieu of a prior $200M milestone, AbbVie pays REGENXBIO $100M on first patient dosed in the DR Phase IIb/III trial and $100M on first patient dosed in a subsequent Phase III trial. REGENXBIO funds Phase IIb of its DR trial; AbbVie independently funds a new Phase III ACHIEVE trial in wet AMD.
REGENXBIO completed enrollment in the ATMOSPHERE and ASCENT pivotal trials of subretinal sura-vec for wet AMD — the largest global gene therapy program for nAMD to date — with topline data expected in 2026.
| Deal | Year | Value | Outcome |
|---|---|---|---|
| AbbVie Inc. / REGENXBIO Inc. (this deal) | 2021 | $1.8B | — |
| AbbVie Inc. / Boehringer Ingelheim GmbH | 2016 | $2.2B | 95 |
| AbbVie Inc. / Genmab A/S | 2020 | $3.9B | 81 |
| AbbVie Inc. / Pharmacyclics Inc. | 2015 | $21.0B | 79 |
| AbbVie Inc. / Apogee Therapeutics, Inc. | 2026 | $10.9B | 72 |
| AbbVie Inc. / ImmunoGen Inc. | 2023 | $10.1B | 69 |
| AbbVie Inc. / Gilgamesh Pharmaceuticals Inc. | 2024 | $2.0B | 64 |
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