In today’s episode of Evidence Based Retina, Rishi P. Singh, MD, is joined by Theodore Leng, MD, MS, FACS, to review recently presented data from the FARETINA studies regarding neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) patients who switched to faricimab from either aflibercept or bevacizumab.
Dr. Leng is a Professor of Ophthalmology at Stanford University and the Byers Eye Institute at Stanford, where he also serves as Director of Clinical and Translational Research.
FARETINA-AMD and FARETINA-DME fast facts
- Design: The FARETINA-AMD and FARETINA-DME studies are two ongoing, retrospective, real-world studies of the initiation of faricimab, analyzing electronic health record data contained within the American Academy of Ophthalmology Intelligent Research in Sight (IRIS) registry.1,2
- Inclusion criteria: Patients included had received at least one injection of faricimab between February and September of 2022; and had a documented diagnosis of either nAMD or DME at the time of selection. Patients also needed to have both 12 months of preindex data and at least 24 months of follow-up data.
- Although both treatment-naïve and previously-treated patients were included, the discussed data only covered those who had previously received anti-VEGF treatment.
- Exclusion criteria: Patients with either unknown injection laterality or missing demographic data were excluded from the study.
- Participants: Using these criteria, the final study cohort contained approximately 4,000 eyes with nAMD (3,700 of which had previously received aflibercept and 300 who had received bevacizumab) and 654 with DME (600 aflibercept and 54 bevacizumab).
The impact of switching to faricimab
The key finding that Dr. Leng highlighted is the extension of the interval between treatment injections without a loss in the stability of visual acuity achieved using other anti-VEGF agents.
Key findings from the FARETINA-AMD and -DME studies:
- For eyes with nAMD that had previously received aflibercept, the researchers observed an average interval extension of 17 days (61-day average total interval after the eighth injection).
- Those previously treated with bevacizumab experienced an average interval extension of 20 days (70-day average interval post-injection eight).
- Eyes with DME saw a 12-day interval extension when previously treated with aflibercept, and an 11-day extension when the switch was from bevacizumab—extending the interval time to 65 and 59 days, respectively.
- Additionally, the study demonstrated a similar safety profile—specifically regarding intraocular inflammation (IOI) and endophthalmitis—to that observed in the phase III registered trials.
When to select faricimab
Although Dr. Leng says that oftentimes the decision of when to prescribe faricimab to a patient ultimately comes down to what insurance will pay for, he shares deeper insight into his personal process.
Dr. Leng notes that different retinal specialists will vary in how quickly they pick up new treatment modalities, residing somewhere on the spectrum from early adopters to early followers to those who wait to follow the majority, and ending with reluctant followers.
As an early adopter/follower, Dr. Leng tends to use and assess therapeutics as soon as they are approved by the FDA, first switching recalcitrant patients (those with persistent fluid despite monthly injections on other anti-VEGF agents) and then, over time and as he develops a level of comfort and understanding of how a drug works in his patient population, expands this use to other patients.
Conclusion
Dr. Leng explains that there are no current plans to stop the FARETINA studies, with him and his colleagues having plans to continue to evaluate this patient cohort over the long term.
He notes that other long-term studies in the anti-VEGF space have all reported a reduction in vision,3 something the FARETINA studies are aiming to explore further.
But as a newer anti-VEGF agent, with the potential for longer intervals while maintaining stability of visual acuity, Dr. Leng hopes that faricimab will be able to buck this trend.
