Aflibercept 8 mg clinical study data now published in The Lancet.-Bayer + Regeneron.

Both studies met their primary endpoint of non-inferior best corrected visual acuity (BCVA) changes with two extended dosing intervals (every 12 or 16 weeks) of Eylea 8 mg compared to standard of care Eylea 2 mg with a fixed 8-week dosing interval, following initial monthly doses. Eylea 8 mg demonstrated unprecedented durability results in the vast majority of patients: 77% of nAMD patients and 89% of DME patients maintained 16-week dosing intervals with Eylea 8 mg with an average of 5 injections (versus 7-8 injections with Eylea 2 mg with a fixed 8-week dosing interval) through week 48. In the 12-week dosing group, 79% of nAMD patients and 91% of DME patients maintained this dosing interval with Eylea 8 mg with an average of 6 injections through week 48. The safety profile of Eylea 8 mg was consistent with that of Eylea 2 mg.

“In its clinical trials, Eylea 8 mg has shown meaningful and clinically relevant benefits, enabling patients to achieve sustained disease control.

" This means uniquely delivering lasting vision gains with extended treatment intervals, rapid and resilient fluid control, and a safety profile comparable to Eylea 2 mg,” said Prof. Paolo Lanzetta, Chairman of the Department of Ophthalmology at the University of Udine, Italy, and a member of the steering committee of the clinical trials.

“Non-adherence and non-persistence remain a significant challenge for patients with retinal diseases due to a need for frequent injections and visits to eye clinics. Eylea 8 mg has the potential to reduce that disease burden by extending treatment intervals. This may contribute to improved adherence and persistence and ultimately improve patient outcomes” said Sobha Sivaprasad, Professor and Consultant Ophthalmologist, Moorfields Eye Hospital, London, UK, and member of the steering committee of the PHOTON study.

See-

"Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase III trial"- Prof Paolo Lanzetta, MD , Prof Jean-François Korobelnik, MD , Jeffrey S Heier, MD ,Sergio Leal, MD, et al. Published: March 07, 2024DOI:https://doi.org/10.1016/S0140-6736(24)00063-1.

"Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase II/III trial"; Prof David M Brown, MD. David S Boyer, MD, Prof Diana V Do, MD, Charles C Wykoff, MD, Prof Taiji Sakamoto, MD, Peter Win, MD, et al. Published: March 07, 2024DOI:https://doi.org/10.1016/S0140-6736(23)02577-1.