Not only is neovascular (wet) age-related macular degeneration (nAMD) one of the leading causes of vision impairment around the world, it also progresses rapidly and can lead to vision loss in as little as three months. Meanwhile, diabetic macular edema (DME) is a common eye complication for people living with diabetes; DME occurs when high levels of blood sugar lead to damaged blood vessels in the eye which leak fluid into the macula. To date, anti-vascular endothelial growth factor (anti-VEGF) drugs, such as aflibercept, are considered the gold standard of treatment in both nAMD and DME, as they help to prevent blindness and improve vision.
Excitingly, Bayer AG, the company which jointly developed aflibercept with Regeneron, recently announced that aflibercept 8 mg meets primary endpoints in two global pivotal studies in nAMD (Phase III PULSAR trial) and DME (Phase II/III PHOTON trial), achieving non-inferior improvements in best corrected visual acuity to Eylea® (aflibercept 2 mg) at week 48. Highest levels of durability were also seen in nAMD and DME where 77% of nAMD and 89% of DME patients maintained every 16-week dosing interval with as few as five injections in the first year.
“These groundbreaking results are excellent news for patients. These outcomes have shown that aflibercept 8 mg not only improved vision with less frequent injections, but also demonstrated a similar safety profile to Eylea,” said Jean-François Korobelnik, trial investigator and professor of ophthalmology and head of the Department of Ophthalmology at University Hospital of Bordeaux in France.
“These pivotal aflibercept 8 mg trials demonstrated that nearly 90% of patients with diabetic macular edema and almost 80% of patients with wet age-related macular degeneration were able to maintain a 16-week dosing regimen,” said David Brown, MD, FACS, trial investigator and director of research at Retina Consultants of Texas, USA. “These unprecedented durability data coupled with a safety profile consistent with that of Eylea support aflibercept 8 mg as a potential new standard-of-care in these diseases.”
PULSAR (n=1009) and PHOTON (n=658) are double-masked, active-controlled pivotal trials that evaluated the efficacy and safety of aflibercept 8mg compared to Eylea. Both trials were conducted in multiple centers globally with similar designs and endpoints. At 48 weeks, both trials met their primary endpoints of non-inferiority of aflibercept 8 mg to Eylea.
“These data mark a new era, as the extended dosing intervals of aflibercept 8 mg significantly reduced the treatment burden for a large majority of patients compared to the more intensive injection frequency currently required,” said Dr. Christian Rommel, member of the Executive Committee of Bayer’s Pharmaceutical Division and head of Research and Development.
Bayer will submit these data to health authorities outside of the United States.