Aflibercept 8 mg first to achieve sustained vision gains with more than 70% of patients extended to intervals between 16 and 24 weeks in wet age-related macular degeneration at two years.- Bayer

At two years (96 weeks), the aflibercept 8 mg combined groups demonstrated that 71% of patients reached a greater than 16-week dosing interval, including 47% reaching 20-week or longer intervals and 28% reaching 24-week intervals. At the end of two years the proportion of patients reaching a greater than 12-week dosing interval remained high (88% at two years vs. 83% at one year).

“These durability results are impressive and demonstrate the sustainable efficacy of treatment with aflibercept 8 mg throughout the second treatment year,” said Professor Dr. Paolo Lanzetta, Chairman of the Department of Ophthalmology at the University of Udine, Italy, and a principal investigator of PULSAR. "Importantly, the vision outcomes for patients on extended treatment intervals with aflibercept 8 mg were consistent with the Eylea 2 mg comparator arm.”

Of those patients randomized at baseline to a 16-week dosing regimen, 78% reached greater than 16-week dosing intervals through two years and 53% greater than 20-week dosing intervals. The number of injections with aflibercept 8 mg was considerably reduced by 4.6 injections over two years down to a mean number of 8.2 injections in the 16-week-group versus 12.8 in the Eylea (aflibercept 2 mg) group with a fixed 8-week dosing interval.

In PULSAR , the safety of aflibercept 8 mg also continued to be similar to Eylea through two years and remained consistent with the known safety profile of Eylea. There were no cases of retinal vasculitis, occlusive retinitis or endophthalmitis in the aflibercept 8 mg group. The rate of intraocular inflammation was 1.3% for the aflibercept 8 mg group and 2.1% for the Eylea (aflibercept 2 mg) group. There was no difference in intraocular pressure increase rates compared to Eylea (aflibercept 2 mg) through two years.

The two-year data from the PULSAR and PHOTON study with aflibercept 8 mg are planned for presentation at upcoming scientific congresses in 2023.

Aflibercept 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea (aflibercept 2 mg) 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 2 mg).