Theodore Leng, MD: Real-World Faricimab Use in FARETINA-AMD Study

New research evaluating early treatment patterns and outcomes among patients with neovascular age-related macular degeneration (nAMD) treated with faricimab suggests a majority of eyes were able to extend treatment intervals in ≥6 months of follow-up.

The data, presented at the American Society of Retina Specialists (ASRS) 41st Annual Meeting, suggest vision remained stable in patients with previously treated eyes after faricimab treatment, while treatment-naive eyes experienced gains in vision after initiating faricimab.

“That was actually really good news for people that were switched over to faricimab, they didn’t lose any vision,” presenting author Theodore Leng, MD, associate professor of ophthalmology, Byers Eye Institute, Stanford University School of Medicine. “They were, in fact, able to extend their dosing interval, which is one of the benefits of switching.”

The standard of care for nAMD remains anti-vascular endothelial growth factor (VEGF) intravitreal therapies, but these require frequent injections, proving a substantial burden for patients and clinics. Approved by the US Food and Drug Administration (FDA) in January 2022, faricimab is the only bispecific antibody for intraocular use that binds angiopoietin-2 and VEGF-A.

However, there is limited data on real-world treatment patterns and outcomes associated with faricimab. The FARETINA-AMD study is the largest ongoing real-world evaluation of injection frequency and early clinical response of patients with nAMD initiating faricimab.

The retrospective study utilized electronic health record data obtained from the American Academy of Ophthalmology Intelligent Research in Sight (IRIS) registry and analyzed from February to September 2022 to identify faricimab starts among eyes diagnosed with nAMD. Investigators used rules-based text search using regular expression keywords to identify the use of faricimab.

Eyes with ≥12 months of electronic health record data prior to initiation and known laterality were included in the study. Those with ≥6 months of electronic health record data after faricimab initiation through December 2022 and ≥4 faricimab injections were included in injection intervals analyses. The study defined injection intervals as extended if any interval was >6 weeks apart.

More than 28,000 eyes have been treated with faricimab through September 2022 in the IRIS registry, of which 79% (n = 22,266) had documentation of nAMD. The final cohort included 17,503 eyes, including 16,419 (93.8%) previously treated eyes and 1084 treatment-naive (6.2%) eyes. Baseline patient demographics were considered well-balanced between groups, with an average age of 80 years with a higher proportion of female patients (62%) in the treatment-naive group.

The analysis indicated 94% of nAMD treated with faricimab were previously treated with anti-VEGF agents, with approximately 67% of patients switched from aflibercept. Previously treated eyes had a mean of 7.4 injections in the prior 12 months with a most recent prior injection interval of approximately 6 weeks.

By September 2022, nearly half of the eyes treated with faricimab had ≥6 months of follow-up, with a mean of 6.7 injections for previously treated eyes and 6.1 injections for treatment-naive eyes. Upon analysis, investigators found 69% of previously treated eyes achieved an extended interval, of which 55% extended after 1-2 injections of faricimab. For treatment-naive eyes, the analysis showed 66% extended the interval, of which 43% extended after 1-2 injections.

Regarding baseline visual acuity, 49% of previously treated eyes and 37% of treatment-naive eyes initiated faricimab at 20/40 or better best-determined visual acuity (BDVA). The analysis showed vision remained stable from baseline in previously treated eyes and vision gains were observed in treatment-naive eyes, with a mean gain of 2 letters.

“Looking at real-world data really helps to fill in that gap about what is happening to patients who have these indications, but may not have qualified for a trial,” Leng said. “Of course, there are limitations to a real-world study, as visual acuity is not collected as exactly as in a trial’s protocol-driven manner. We don’t have insight into the physician’s decision-making process to switching or extending and so forth. But I think it is important to fill in those gaps.”

Relevant disclosures for Dr. Leng include Astellas, Boehringer Ingelheim, Genentech, Kodiak, Regeneron, and others.