Early real-world data presented at the 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting suggests that aflibercept 8 mg offers extended dosing intervals for patients with neovascular age-related macular degeneration (nAMD), potentially reducing treatment burden.
Real-World Evidence from Large Patient Cohorts
Researchers combined data from two major ophthalmology databases—Intelligent Research in Sight (IRIS) and Vestrum Health Retina Database—to analyze the effectiveness of aflibercept 8 mg in clinical practice. The analysis included nearly 40,000 eyes that initiated aflibercept 8 mg treatment between August 2023 and July 2024.
"I'm really excited about this study because it is a real-world data study which allows us an insight into how aflibercept 8 mg is being used in the AMD and DME population since it launched," said Theodore Leng, MD, Director of Clinical and Translational Research and Director of Ophthalmic Diagnostics at Stanford University School of Medicine. "The other exciting part about this study is that we combined data from two separate real-world data sets."
Extended Dosing Intervals in Treatment-Experienced Patients
The study revealed significant extensions in dosing intervals for patients who switched to aflibercept 8 mg from other anti-VEGF agents. Approximately 71% of patients switched from aflibercept 2 mg, while 18% transitioned from faricimab.
For consistently treated eyes with at least one post-loading phase injection, the last post-loading dosing interval was on average 16-18 days longer than the last observed interval prior to switching. The extension was even more pronounced in specific subgroups:
- Patients previously on 4-6 week injection intervals: 19-21 day extension
- Patients previously on 6-8 week injection intervals: 12-16 day extension
"Typically, the most common reason for switching is a lack of efficacy or suboptimal treatment response, or the desire to have longer treatment intervals between the injections," Dr. Leng explained. "If your goal is to have fewer visits, that can come from either the patient side or from a clinical flow operational side, from the physician side. Then even patients who are only going to get a few more weeks might still be worth to consider switching."
Treatment-Naive Patient Outcomes
In a separate analysis presented at ARVO 2025, researchers examined aflibercept 8 mg in treatment-naive nAMD patients. This study included approximately 3,000 eyes from the IRIS database and 1,300 eyes from the Vestrum database.
"We saw some improvements that we might expect. So patients that had vision of 20/50, or worse, we saw meaningful improvements in their vision as captured through the database," reported Ferhina Ali, MD, MPH, a retina specialist from New York Medical College and West Chester Medical Center.
The analysis divided treatment into an initial dosing phase (first 3 injections or 90 days) and a follow-up period. Dr. Ali noted, "What we found is that, on average, we saw an interval at about 10 weeks, as measured by this database. So meaning the potential for extension and durability up to that point based on how we're following this cohort at this time."
Clinical Implications and Future Research
These early real-world findings appear to validate the durability benefits observed in clinical trials like PULSAR, though researchers emphasize that longer follow-up is needed to fully understand the long-term durability of aflibercept 8 mg.
"We're always interested in validating what we see in the clinical trial setting. We know that clinical trials are a very specific cohort, and those patients are sort of very strictly followed," Dr. Ali explained. "We're always going to be interested in real-world data to see if it mirrors what was seen in the clinical trials, and then that helps us inform our decision making for kind of what treatment intervals may be possible for the patient."
Future analyses will also focus on real-world safety data, which was not explored in these initial studies. As the cohorts mature and longer follow-up becomes available, researchers plan to provide more comprehensive information on both efficacy and safety to guide clinical decision-making.
The potential for extended treatment intervals with aflibercept 8 mg could significantly reduce the treatment burden for nAMD patients, many of whom are elderly and may face challenges with frequent clinic visits for injections.
