Biologics license application for aflibercept 8 mg receives priority review
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The FDA accepted for priority review the biologics license application for aflibercept 8 mg for the treatment of wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy, according to a Regeneron press release.
The target action date for the review is June 27.
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The application is supported by positive data from the pivotal PULSAR trial in wet AMD and PHOTON trial in DME. At 48 weeks, those treated with high-dose aflibercept in both trials met the primary endpoint of noninferiority in vision gains compared with treatment with Eylea (aflibercept 2 mg) for both the 12- and 16-week dosing regimens.
In addition, the majority of participants randomly assigned to aflibercept 8 mg were able to maintain the 12- and 16-week dosing regimens through 48 weeks, the release said.
The safety profile of higher-dose aflibercept was similar to and consistent with Eylea. Retinal vasculitis, occlusive retinitis and endophthalmitis were not reported in either trial.
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