Aflibercept 8 mg first to achieve extended injection intervals of 16 weeks in up to 89% of patients
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Aflibercept 8 mg meets primary endpoints in two global pivotal studies in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) achieving non-inferior improvements in best corrected visual acuity to Eylea® (aflibercept 2 mg) at week 48 / Highest levels of durability seen in nAMD and DME: 77% of nAMD and 89% of DME patients maintained every 16-week dosing intervals with as few as 5 injections in the first year / Aflibercept 8 mg safety consistent with the well-established safety profile of Eylea / Bayer will submit these data to health authorities outside of the U.S.
Berlin, September 8, 2022 – Bayer AG today announced the primary endpoint was met in two pivotal trials investigating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) at week 48. The Phase III PULSAR trial in nAMD and Phase II/III PHOTON trial in DME evaluated the non-inferiority of the two aflibercept 8 mg extended-dosing regimens in terms of best corrected visual acuity (BCVA), compared to Eylea® (aflibercept 2 mg) dosed every 8-week following initial monthly doses. In these trials, the safety of aflibercept 8 mg was consistent with the well-established safety profile of Eylea. Bayer will submit these data to regulatory authorities outside of the U.S..
“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, Professor of Ophthalmology and Head of the Department of Ophthalmology at University Hospital of Bordeaux in France and a trial investigator.
“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, M.D., FACS, Director of Research at Retina Consultants of Texas in the U.S. and a trial investigator. “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.”
Aflibercept 8 mg was investigated in two double-masked, active-controlled pivotal trials – PULSAR (n=1009) in nAMD and PHOTON (n=658) in DME – to evaluate efficacy and safety 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. Additional results were as follows:
In the aflibercept 8 mg 16-week dosing groups, 77% of nAMD patients in PULSAR (n=312) and 89% of DME patients in PHOTON (n=156) were able to maintain 16-week injection intervals with an average of 5 injections in the first year.
In the aflibercept 8 mg 12-week dosing groups, 79% of nAMD patients in PULSAR (n=316) and 91% of DME patients in PHOTON (n=300) were able to maintain 12-week injection intervals with an average of 6 injections in the first year.
In a pooled analysis of aflibercept 8 mg dosing groups, 83% of nAMD patients in PULSAR and 93% of DME patients in PHOTON maintained 12-week dosing or longer.
The safety of aflibercept 8 mg in both trials was similar to the well-established safety profile of Eylea and consistent with the safety of Eylea observed in previous clinical trials. Comparing aflibercept 8 mg to Eylea, the rates of serious ocular adverse events were 1.6% versus 0.6% in PULSAR and 0.6% versus 0.6% in PHOTON. The rates of intraocular inflammation for aflibercept 8 mg compared to Eylea were 0.7% versus 0.6% in PULSAR and 0.8% versus 0.6% in PHOTON. There were no clinically relevant differences in intraocular pressure between the treatment groups. In both trials, there were no cases of retinal vasculitis and no new safety signals.
“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. “All of this was accomplished while improving and maintaining vision with comparable safety to Eylea.”
Detailed efficacy and safety data from PHOTON and PULSAR are planned for presentation at an upcoming medical meeting.
Aflibercept 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea and aflibercept 8 mg in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea.
Aflibercept 8 mg is investigational, and its safety and efficacy have not yet been evaluated by any regulatory authority.
About nAMD and DME
Neovascular (wet) age-related macular degeneration (nAMD) is an eye disease that progresses rapidly and if left untreated can lead to vision loss in as little as three months. nAMD is one of the leading causes of irreversible blindness and vision impairment around the world. nAMD may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This fluid can damage and scar the macula, which can cause vision loss. 196 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040.
Diabetic macular edema (DME) is a common complication in eyes of people living with diabetes. DME occurs when high levels of blood sugar lead to damaged blood vessels in the eye that leak fluid into the macula. This can lead to vision loss and, in some cases, blindness. Globally, 146 million people are currently living with diabetic retinopathy (DR), which can develop into a more serious condition which is diabetic macular edema (DME).
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