surabgene lomparvovec (ABBV-RGX-314) / REGENXBIO, AbbVie - LARVOL DELTA

Sura-vec for the Treatment of Wet AMD (Subretinal Delivery) (PRNewswire) - "REGENXBIO expects to announce topline data with AbbVie from the ATMOSPHERE and ASCENT pivotal trials of sura-vec using subretinal delivery in Q4 2026; Global regulatory submissions are expected in 2027."

Filing • P2/3 data • P3 data: top line • Wet Age-related Macular Degeneration

RGX-314-5201: Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy (clinicaltrials.gov) - P2 | N=100 | Enrolling by invitation | Sponsor: AbbVie | Phase classification: P ➔ P2 | Trial completion date: May 2028 ➔ Jun 2031 | Trial primary completion date: May 2028 ➔ Jun 2031

Phase classification • Trial completion date • Trial primary completion date • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

RGX-314-5102: Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD (clinicaltrials.gov) - P2 | N=116 | Enrolling by invitation | Sponsor: AbbVie | Phase classification: P ➔ P2 | Trial completion date: Mar 2028 ➔ Jul 2031 | Trial primary completion date: Mar 2028 ➔ Jul 2031

Phase classification • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

ASCENT: Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD (clinicaltrials.gov) - P3 | N=735 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

ABBV-RGX-314: Data from P2/3 ATMOSPHERE trial (NCT04704921) for wAMD in 2027 (AbbVie) - Q2 2026 Results: Top-line data from P3 ASCENT trial (NCT05407636) for wAMD in 2027

P2/3 data • P3 data: top line • Ophthalmology • Wet Age-related Macular Degeneration

Sura-vec for the treatment of wet AMD: 5-year data summary (PRNewswire) - "Participants in Cohorts 3 and 4 of the Phase I/IIa trial received subretinal sura-vec at doses...and demonstrated stable to improved visual acuity and had meaningful reductions in anti-VEGF treatment burden through five years, apart from a polypoidal participant in Cohort 4 with polypoidal choroidal vasculopathy, refractory to anti-VEGF...No new safety signals were identified in long-term follow-up, including no intraocular inflammation observed in participants who completed the Phase I/IIa study....Data from an external control study of sura-vec compared to real-world anti-VEGF intravitreal injections in wet AMD were also presented at ASRS. At one year, vision was preserved for sura-vec participants compared to real-world anti-VEGF external control-matched participants. Participants who received sura-vec also maintained or improved BCVA gains, had less central retinal thickness fluctuation, and received significantly fewer injections."

P1/2 data • Age-related Macular Degeneration • Wet Age-related Macular Degeneration

Sura-vec for the treatment of DR: 2.5-year data summary (PRNewswire) - "In long-term follow-up from the Phase II ALTITUDE trial, a single in-office administration of sura-vec using suprachoroidal delivery in participants with non-proliferative DR (NPDR) at Dose Level 3 (1.0×10¹² GC/eye) with short-course prophylactic topical steroids, the same dose being evaluated in the Phase IIb/III NAAVIGATE trial, demonstrated a durable safety and efficacy profile through 2.5 years. 55% of participants achieved >2 step improvement on the Diabetic Retinopathy Severity Scale (DRSS) without additional treatment, and 70% of participants experienced no vision-threatening events...Additionally, the majority of patients who achieved a 1-step DRSS improvement at one year post-treatment went on to achieve a 2-step DRSS improvement by 2.5 years....As of May 25, 2026, sura-vec was well tolerated with no intraocular inflammation observed through 2.5 years (n=17) with short-course prophylactic topical steroids."

P2 data • Diabetic Retinopathy

New long-term data from diabetic retinopathy and wet AMD programs to be presented at American Society of Retina Specialists (ASRS) 2026 (Yahoo Finance) - "REGENXBIO plans to present two and a half-year data from the long term follow up study of the ALTITUDE trial at the ASRS 44th Annual Meeting in July 2026. In two-year dose level 3 data from the ALTITUDE trial, sura-vec demonstrated a durable efficacy profile and was well tolerated with no intraocular inflammation observed (n=15), supporting the potential of an in-office gene therapy approach.....Five-year long-term follow-up data from the Phase I/IIa study of subretinal sura-vec for wet AMD will also be presented at ASRS."

P1/2 data • P2 data • Diabetic Retinopathy • Wet Age-related Macular Degeneration

REGENXBIO Announces First Patient Dosed in Phase IIb/III NAAVIGATE Trial of Surabgene Lomparvovec in Diabetic Retinopathy; Company to Receive $100 Million Milestone (Yahoo Finance) - "The Phase IIb portion, operationalized by REGENXBIO, is expected to enroll approximately 135 participants in the United States."

Financing • Trial status • Diabetic Retinopathy

Sura-vec for the Treatment of Wet AMD (Subretinal Delivery) (Yahoo Finance) - "REGENXBIO expects to share topline data with AbbVie from ATMOSPHERE and ASCENT pivotal trials of sura-vec using subretinal delivery in Q4 2026; Global regulatory submissions are expected in 2027."

Filing • P2/3 data • P3 data: top line • Wet Age-related Macular Degeneration

NAAVIGATE: Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema (clinicaltrials.gov) - P2/3 | N=576 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

NAAVIGATE: Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema (clinicaltrials.gov) - P2/3 | N=576 | Not yet recruiting | Sponsor: AbbVie

New P2/3 trial • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

Sura-vec for the Treatment of DR (Suprachoroidal Delivery) (Yahoo Finance) - "U.S. clinical sites are active and initiating enrollment in the Phase IIb/III NAAVIGATE study....REGENXBIO will receive a $100 million milestone payment from AbbVie upon first patient dosed in the Phase IIb portion of NAAVIGATE, expected in Q2 2026."

Financing • Trial status • Diabetic Macular Edema

Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) (clinicaltrials.gov) - P3 | N=561 | Recruiting | Sponsor: AbbVie

Adverse events • Real-world evidence • Trial initiation date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Subretinal Sura-vec Maintains or Improves Vision (BCVA) and Retinal Thickness (CRT) in Subjects with Neovascular Age-Related Macular Degeneration: A Time in Range Analysis (ARVO 2026) - "Conclusions These data indicate that sura-vec maintains or improves best corrected visual acuity (BCVA) and central retinal thickness (CRT) for most of the 48-week period for both LD and HD, (i.e. the subject remains in the favorable range for most [>95%] of the 48 week duration). These findings highlight sura-vec's potential as a long-term treatment, ensuring functional and anatomic stability."

Clinical • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Impact of Neovascular AMD Disease Duration on Investigational Subretinal Surabgene lomparvovec (Sura-vec; ABBV-RGX-314) Outcomes: A Subgroup Analysis (ARVO 2026) - "Shorter nAMD disease duration at the time of sura-vec administration was associated with numerically better vision and anatomical outcomes, and lower supplemental injection burden over 48 weeks. This analysis is limited by the small sample size, and similar subgroup analyses may be conducted in the future following completion of the sura-vec pivotal studies (ATMOSPHERE® and ASCENT™)."

Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Lower Central Retinal Thickness Fluctuations are Associated with Better Vision Outcomes in nAMD Subjects Treated with Subretinal Sura-vec (ARVO 2026) - "Additional research is needed to verify whether higher CRT fluctuations are associated with a higher incidence of fibrosis. Furthermore, it will be important to explore how sura-vec outcomes compare to those achieved with anti-VEGF standard of care treatment in a real-world setting."

Clinical • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Subretinal Delivery of Investigational Sura-vec (ABBV-RGX-314) as a Gene Therapy for Neovascular Age-Related Macular Degeneration (nAMD): One-year Results of Bilateral Dosing from a Fellow Eye Study (ARVO 2026) - "Results support continued evaluation in larger studies. This is an interim analysis performed by REGENXBIO."

Gene therapy • Age-related Macular Degeneration • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis • Wet Age-related Macular Degeneration

Evaluating Agreement Between Notal Home Optical Coherence Tomography (OCT) and In-Office OCT for Central Retina Thickness (CRT) in an Investigational sura-vec Phase 2 Study (ARVO 2026) - P2 | "Bland-Altman analysis indicates that the measurements are nearly equivalent, with a slight bias as the mean value of the differences is >0, indicating that in-office OCT values tended to be slightly larger than those at-home. Given the high level of agreement between at-home and in-office OCT measurements, home-based OCT technology could enable more decentralized clinical trial designs, improving patient accessibility, and data collection frequency in future research."

P2 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

ATMOSPHERE: Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD (clinicaltrials.gov) - P2/3 | N=671 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) (clinicaltrials.gov) - P3 | N=561 | Recruiting | Sponsor: AbbVie

Adverse events • Real-world evidence • Trial initiation date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

AAVIATE: RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD) (clinicaltrials.gov) - P2 | N=146 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Emerging drugs for diabetic retinopathy: an overview of therapeutic innovation. (PubMed, Ther Adv Ophthalmol) - No abstract available

Journal • Diabetic Retinopathy • Retinal Disorders

AAV-based gene therapies for neovascular AMD. (PubMed, Gene Ther) - "This review summarizes the rationale for AAV use in ocular gene therapy, compares major delivery routes, and highlights leading clinical candidates, including RGX-314, ADVM-022, 4D-150, and NG101. Future directions include next-generation capsids, combination regimens, and precision patient selection. Collectively, these developments position AAV-based gene therapy as a promising strategy to redefine the therapeutic landscape of nAMD."

Journal • Review • Age-related Macular Degeneration • Gene Therapies • Immune Modulation • Immunology • Inflammation • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

REGENXBIO Reports First Quarter 2025 Financial Results and Recent Operational Highlights (PRNewswire) - "Sura-vec for the Treatment of Wet AMD (Subretinal Delivery): Enrollment is ongoing in the ATMOSPHERE and ASCENT pivotal trials. REGENXBIO and AbbVie expect to share topline results in 2026."

Clinical data • Enrollment status • Wet Age-related Macular Degeneration