Aflibercept with higher dose given at longer interval Promising in neovascular eye disease

Aflibercept 8 mg is investigational, and its safety and efficacy have not been evaluated by any regulatory authority.

According to two randomized trial, increasing dose of aflibercept (Eylea) with prolonged treatment intervals for neovascular eye disease was not associated with with a loss in efficacy or major increase in adverse events. The trial showed that a dose of 8 mg of aflibercept every 12 or 16 weeks for DME, AMD matched results with a dose of 2 mg every 8 weeks.

The findings of the two trials have been presented at meeting of American Association of Ophthalmology.

"Our presentations at AAO demonstrate that aflibercept 8 mg 12- and 16-week dosing regimens have achieved a high bar, sustaining improvements in visual acuity and anatomic measures of retinal fluid across 48 weeks in patients with diabetic macular edema and wet age-related macular degeneration," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron, and a principal inventor of aflibercept.

"These results were all achieved in patients who were rapidly initiated on extended dosing intervals with the vast majority not requiring regimen modification. Altogether, the pivotal data support aflibercept 8 mg as providing a longer duration of action while maintaining a safety profile similar to EYLEA."

As presented at AAO, the PHOTON trial in DME and the PULSAR trial in wAMD both met the same primary endpoint. Aflibercept 8 mg demonstrated non-inferiority in vision gains in both the 12- and 16-week dosing regimens after initial monthly doses at 48 weeks compared to an EYLEA 8-week dosing regimen. Furthermore, 91% and 89% of DME patients and 79% and 77% of wAMD patients respectively randomized to 12- and 16-week dosing maintained those intervals through 48 weeks.

The safety of aflibercept 8 mg was similar to EYLEA in both trials, and consistent with the known safety profile of EYLEA from previous clinical trials. Comparing aflibercept 8 mg to EYLEA, ocular adverse events occurred in 31% versus 28% in PHOTON and 38% versus 39% in PULSAR, and there were no cases of retinal vasculitis, occlusive retinitis or endophthalmitis in either trial.

Data from PHOTON and PULSAR were first shared in early September, and the full AAO presentations are available on the Regeneron website.

Aflibercept 8 mg is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron maintains exclusive rights to EYLEA and aflibercept 8 mg. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of EYLEA.