Q&A: Updates on faricimab for DME from ASRS 2025

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The 2025 meeting of the American Society of Retina Specialists (ASRS) meeting is taking place in Long Beach, California. At this event, Veeral S. Sheth, MD, MBA, FASRS, FACS, gave a presentation titled, "Update on Faricimab for DME: New Clinical Features of Eyes in the RHONE-X Long-Term Extension Study."

In this question and answer session, Sheth highlights key points from this presentation and speaks to the value of the data gathered for the ophthalmic community.

Note: The following responses have been lightly edited for clarity.

Ophthalmology Times: Can you share a few key highlights from your presentation at ASRS 2025?

Veeral S. Sheth, MD, MBA, FASRS, FACS: In RHONE-X, we demonstrated that faricimab’s efficacy and safety were sustained over 4 years. Over 90% of patients achieved CST < 325 µm by the end of the study, and >50% met criteria for Q20W dosing. Importantly, visual and anatomical gains from the parent trials were maintained long term with fewer injections for many patients. Faricimab also continued to be well tolerated, consistent with its known safety profile.

OT: What patient population makes up this extension study?

Sheth: RHONE-X enrolled patients with diabetic macular edema (DME) who completed the YOSEMITE or RHINE trials without discontinuing study treatment. These patients entered a long-term extension phase of up to 2 additional years, giving us up to 4 years of continuous data on faricimab-treated eyes.

OT: Were there any surprising or unexpected results in these data?

Sheth: One of the more striking findings was how quickly patients reached disease control with faricimab compared to aflibercept. On average, patients who started on faricimab achieved CST < 325 µm 12–15 months earlier than those who started on aflibercept. We also saw a continued reduction in hard exudates and a higher proportion of patients achieving anatomical dryness after switching from aflibercept.

OT: How might these results impact how retina specialists are using faricimab for their patients with DME?

Sheth: The long-term data reinforce the durability and consistency of faricimab in managing DME. The ability to extend dosing to Q16W and even Q20W in many patients supports its use as a first-line agent, especially for those in whom treatment burden is a concern. It also highlights the value of individualized treat-and-extend regimens in long-term disease management.

OT: Did this study provide any insights into DME as a disease state? If so, what have we learned?

Sheth: Yes, RHONE-X helps clarify the trajectory of DME under long-term anti-VEGF/Ang-2 inhibition. We saw that extended control is achievable in a large percentage of patients, and that early, effective treatment may influence long-term disease stability. The data also underscore that DME is dynamic over time, with structural improvements continuing well into years 3 and 4.

OT: How can long-term studies or continued follow-up provide us with insights into the efficacy of a treatment?

Sheth: Long-term studies like RHONE-X help differentiate between treatments that offer short-term gains and those that provide sustained control. They show us how durable treatment effects really are, inform retreatment strategies, and provide insight into safety beyond the typical 1–2 year window. This is essential in chronic diseases like DME where patients may be treated for many years.

OT: As you consider current and potential therapeutics for treating patients with DME, what do you hope the future holds?

Sheth: I hope we continue to move toward personalized therapy that balances efficacy with quality of life. Agents like faricimab that offer dual-pathway inhibition and extended durability are a major step forward. In the future, I’d like to see even more targeted and sustained delivery options, better biomarkers to guide treatment, and improved access so all patients benefit from these advances.