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Regeneron Presents Encouraging Phase 2 Results for High-dose Aflibercept 8 mg in Wet Age-related Macular Degeneration at Angiogenesis Meeting
TARRYTOWN, N.Y., Feb. 11, 2022 /PRNewswire/ -- Trial met primary safety endpoint and no new safety signals seen through week 44 Results favored aflibercept 8
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y., Feb. 11, 2022 /PRNewswire/ -- \nTrial met primary safety endpoint and no new safety signals seen through week 44\nResults favored aflibercept 8 mg in visual acuity, drying and other anatomical measures through week 44\nPhase 3 results in wet age-related macular degeneration and diabetic macular edema expected in the second half of 2022\nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced results from its Phase 2 proof-of-concept trial evaluating an investigational 8 mg high dose of aflibercept compared to the currently-approved 2 mg dose of EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The results will be presented at the Angiogenesis (Angiogenesis, Exudation, and Degeneration) 2022 annual meeting on Saturday, February 12. \nAs previously announced, more patients treated with aflibercept 8 mg had no retinal fluid at week 16, when the primary efficacy endpoint was assessed. At this timepoint, 43% (n=23/53) had no fluid in the macula compared to 26% for EYLEA (n=14/53) (p=0.0667); and 51% (n=27) had no fluid in the center subfield compared to 34% for EYLEA (n=18) (p=0.0770). At week 16, patients in both treatment groups had received three initial doses (administered at weeks 0, 4 and 8), after which dosing was extended to every 12 weeks. In new results presented for the first time, aflibercept 8 mg continued to show numeric improvements in anatomical and vision outcomes compared to EYLEA through 44 weeks. \n\"These Phase 2 data in wet AMD demonstrate the exciting potential for aflibercept 8 mg to maintain dryness and improve vision compared to the standard-of-care EYLEA,\" said Dr. David Brown, Director of Research at Retina Consultants of Texas. \"This is the first time we have seen a promising trend towards sustained improved vision over EYLEA in wet AMD. I look forward to seeing the results of the Phase 3 program investigating extended dosing of aflibercept 8 mg.\"\nEyes treated with aflibercept 8 mg were more likely to be dry in the center subfield on optical coherence tomography (OCT) compared to EYLEA at every timepoint measured throughout the trial after the initial monthly dosing period. At week 44 when the trial ended, key anatomical and vision changes included:\n40% (n=21/53) of patients treated with aflibercept 8 mg did not have fluid in the c...