New data presented at the ARVO 2026 Annual Meeting highlighted how DME management continues to evolve beyond VEGF alone, with a growing focus on durability, treatment burden reduction and more personalized pathway-driven care
At the ARVO 2026 Annual Meeting, DME remained a major focus, with multiple studies exploring how clinicians may extend treatment intervals, improve outcomes in suboptimal responders and target inflammatory pathways beyond VEGF. Across phase 2 and phase 3 trials, as well as real-world observational studies, key themes included long-term durability with faricimab, sustained-delivery approaches, and growing evidence supporting dual-pathway strategies that may help address the heterogeneity of DME in routine practice.
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Phase 2 ALLUVIUM trial positions IL-6 as a new therapeutic target in DME
The phase 2 ALLUVIUM trial evaluated vamikibart, a first-in-class anti-IL-6 antibody, for treating DME. Results demonstrated that IL-6 inhibition independently improves visual and anatomical outcomes, though vamikibart monotherapy was less robust than ranibizumab and associated with higher inflammation rates. Most significantly, the study confirms IL-6 as a pathogenic driver distinct from VEGF. These findings provide a critical clinical rationale for future combination strategies targeting both inflammatory and angiogenic pathways to address suboptimal anti-VEGF responses in DME patients.
Presenting author Dr Arshad M Khanani shared his thoughts with us:
“In the Phase 2 ALLUVIUM study, we evaluated efficacy and safety of vamikibart (anti-IL6) intravitreal injection in patients with DME as a monotherapy compared to ranibizumab. The results show that vamikibart monotherapy demonstrated improvements from baseline in both BCVA and anatomical outcomes across all doses in patients with DME. A higher rate of intraocular inflammation in the high-dose vamikibart group. In my opinion, IL-6 inhibition with vamikibart provides a clinical effect distinct from VEGF blockade. These findings from the ALLUVIUM study are important for our field, and they provide a rationale for exploring a combination of anti–IL-6 and anti-VEGF to simultaneously target both inflammatory and angiogenic pathways in patients with DME.”
Abstract information: Khanani AM et al. Efficacy and safety of vamikibart in patients with diabetic macular edema: first results from the phase 2 ALLUVIUM trial. ARVO 2026 Annual Meeting; 3–7 May, 2026; Denver, Colorado.
BARDENAS trial suggests dual IL-6 and VEGF blockade may improve visual outcomes
Building on the mechanistic signal seen in ALLUVIUM, a further study explored whether combining IL-6 inhibition with VEGF blockade could translate into greater functional benefit for patients with DME. The Phase 2 BARDENAS trial investigated whether combining vamikibart, a first-in-class anti-IL-6, with ranibizumab offers superior outcomes for DME compared to standard anti-VEGF monotherapy. Results demonstrated significant visual and anatomical gains with combination therapy, including a substantially higher proportion of patients achieving a 15-letter visual improvement. These findings suggest that IL-6 inhibition provides a clinical effect distinct from VEGF blockade, targeting the multifactorial drivers of the disease. While safety monitoring for intraocular inflammation remains important, BARDENAS establishes a robust rationale for dual-pathway therapeutic strategies to optimize functional outcomes in DME management.
Presenting author Dr Roger Goldberg shared his thoughts with us:
“These results, which demonstrated improved visual acuity gains both in terms of mean change in best corrected visual acuity, as well as a responder analysis looking at proportion of three-line gainers, together with improved anatomic benefits, show that targeting IL-6 in conjunction VEGF-a can lead to better outcomes for our patients with DME. We know that while anti-VEGF agents work well, about a third of patients are sub-optimal responders, and likely have a more inflammatory phenotype. Targeting IL-6 may help address this significant unmet need.”
Abstract information: Goldberg RA et al. Efficacy and safety of vamikibart in combination with ranibizumab in patients with diabetic macular edema: first results from the phase 2 BARDENAS trial. ARVO 2026 Annual Meeting; 3–7 May, 2026; Denver, Colorado.
Real-world VOYAGER study confirms one-year durability of faricimab in routine DME care
The VOYAGER study evaluated the one-year real-world effectiveness and safety of faricimab for DME. The study found that treatment-naïve eyes achieved significant vision gains and anatomical improvements, while previously treated eyes maintained stable vision and showed stabilized retinal thickness. Notably, injection frequency decreased substantially in the second half of the year for both groups, demonstrating the real-world durability of faricimab.
Additional 12-month data presented at the meeting further highlighted how faricimab is being used in routine clinical practice across global centres treating AMD, RVO and DME. A notable finding was that patients with DME were treated earlier in the disease course than in pivotal clinical trials, with a baseline visual acuity of approximately 65 ETDRS letters compared with around 61 letters in landmark studies. These findings suggest clinicians are becoming more proactive in initiating treatment before substantial vision loss occurs. With low rates of inflammation and endophthalmitis, the VOYAGER data continue to support faricimab as a safe and effective treatment option that can reduce treatment burden while delivering durable real-world outcomes for patients with DME.
Dr Monica Loevestam-Adrian shared her perspective on why the real-world VOYAGER data may represent an important shift in the management of chronic DME:
“The most interesting finding for me was in the chronic DME population, where many patients had already received years of anti-VEGF treatment and a high number of injections, so these were truly difficult-to-treat eyes. Historically, we have often associated this chronic edema with inflammation and turned to steroids, but faricimab’s dual Ang-2 and VEGF-A inhibition may offer a way to address inflammatory components without the steroid-related side effects we worry about in clinical practice. Another unique aspect of the VOYAGER study is the large-scale image collection from clinics worldwide, which will allow us to explore anatomical markers of inflammation, such as hyperreflective changes and hard exudates, alongside visual and fluid outcomes. It is a really important real-world dataset that will continue to evolve as the study progresses beyond two years.”
Abstract information: Loevestam-Adrian M et al. One-year outcomes of faricimab patients with diabetic macular edema from a global, prospective observational study: the VOYAGER study. ARVO 2026 Annual Meeting; 3–7 May, 2026; Denver, Colorado.
Two-year FARWIDE data reinforce faricimab durability in UK clinical practice
Building on the one-year findings from the VOYAGER study, investigators also presented two-year results from the UK FARWIDE-DME study, providing one of the most comprehensive real-world assessments of faricimab in routine clinical practice. The study, the largest real-world analysis of faricimab outside the US, showed sustained visual outcomes over two years, with treatment-naïve eyes achieving meaningful vision gains and previously treated eyes maintaining vision while extending treatment intervals. Injection frequency declined markedly after the first six months, highlighting the potential to reduce treatment burden in everyday practice. Safety findings remained consistent with those observed in phase 3 clinical trials.
Presenting author Dr Tunde Peto shared her thoughts with us:
“I was thrilled to share the most recent results from FARWIDE-DME, the largest real-world study of faricimab outside the US, at the ARVO meeting. The latest analyses included a total of 3,077 eyes with DME from 34 centres in the UK that had received at least 2 years of faricimab treatment. We found that vision improved by approximately 4 ETDRS letters in treatment-naïve eyes and was stable in previously-treated eyes. The injection frequency decreased through the 2 years in both treatment-naïve and previously-treated eyes. Furthermore, previously-treated eyes had substantial treatment interval extensions, highlighting the potential of faricimab to reduce treatment burden.
Importantly, the rates of intraocular inflammation and endophthalmitis were low and consistent with those reported in clinical trials and other real-world studies of faricimab. Taken together, the findings presented at ARVO further support the effectiveness, durability, and safety of faricimab for treatment of DME.”
Abstract information: Peto T et al. Long-term effectiveness and safety of faricimab in eyes with diabetic macular edema: 2-year results from the UK FARWIDE-DME study. ARVO 2026 Annual Meeting; 3–7 May, 2026; Denver, Colorado.
Bioerodible EYP-1901 insert extends treatment durability in phase 2 VERONA trial
The Phase 2 VERONA trial evaluated the efficacy of EYP-1901, a bioerodible intravitreal insert providing sustained release of the pan-VEGFR and JAK1 inhibitor vorolanib, for treating DME.
The study met its primary endpoint, demonstrating that a single EYP-1901 injection significantly extended the time to first supplemental anti-VEGF treatment compared to aflibercept alone. Patients experienced rapid, sustained improvements in visual acuity and retinal anatomy, alongside notable reductions in macular leakage and volume. These findings suggest that EYP-1901 could substantially reduce treatment burden while maintaining clinical outcomes, supporting its advancement into Phase 3 trials.
Abstract information: Talcott KE et al. VERONA phase 2 clinical trial of bioerodible EYP-1901 (vorolanib intravitreal insert) versus aflibercept for diabetic macular edema: visual, anatomic, and angiographic outcomes. ARVO 2026 Annual Meeting; 3–7 May, 2026; Denver, Colorado.
Phase 3 RC28-E meets efficacy endpoint and shows added benefit in advanced diabetic retinopathy
This Phase 3 trial compared RC28-E, a novel bispecific inhibitor of VEGF and FGF-2, with aflibercept for treating DME. Results demonstrated that RC28-E is non-inferior to aflibercept in improving visual acuity at 52 weeks. Notably, RC28-E showed superior efficacy in improving diabetic retinopathy severity, particularly in patients with more advanced non-proliferative disease. With a safety profile comparable to aflibercept, RC28-E represents a promising therapeutic option that addresses dual pathways to achieve robust functional and anatomical gains in patients with center-involved DME.
Abstract information: Chen Y et al. Intravitreal RC28-E, a Recombinant Fusion Protein with Simultaneous Inhibition of Fibroblast Growth Factor-2 and Vascular Endothelial Growth Factor in patients with Diabetic Macular Edema: 52-week Results from a Randomized, Double-masked, Phase 3 Trial. ARVO 2026 Annual Meeting; 3–7 May, 2026; Denver, Colorado.
Key takeaway
The DME data presented at ARVO 2026 Annual Meeting suggest that the field continues to evolve on multiple fronts, from longer durability in real-world practice and sustained-delivery approaches designed to reduce injection burden, to novel inflammatory and dual-pathway strategies aimed at addressing the biological complexity of the disease. Emerging data with faricimab, the bioerodible EYP-1901 insert, IL-6 inhibition with vamikibart, and the bispecific agent RC28-E highlight a pipeline increasingly focused not only on maintaining vision, but also on extending treatment intervals, targeting suboptimal responders and potentially delivering more individualized care in the future.
Cite: ARVO 2026: DME data spotlight longer durability, IL-6 inhibition and emerging dual-pathway therapies touchOPHTHALMOLOGY. 2 June 2026.
Editor: Nicola Cartridge, Director of Content
Acknowledgment: This content has been developed independently by Touch Medical Media for touchOPHTHALMOLOGY. It is not affiliated with ARVO. Views expressed are the speaker’s own and do not necessarily reflect the views of Touch Medical Media. No funding was received in the publication of this short article. This article was created by the touchOPHTHALMOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-5.4) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article. Thank you to the presenting authors for sharing their perspectives.
