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Regeneron Touts Mid-Stage Win For Higher Dose Of Eylea In Age-related Macular Degeneration

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  • Regeneron Pharmaceuticals Inc (NASDAQ: REGN) revealed new Phase 2 proof-of-concept trial data on Eylea (aflibercept) injection in patients with wet age-related macular degeneration (wet AMD).

  • 43% of wet age-related macular degeneration patients dosed with an 8 mg dose of Eylea reported no retinal fluid after four weeks compared with 26.4% of patients receiving a 2 mg dose of the drug.

  • Regeneron and Bayer AG (OTC: BAYRY) are jointly developing aflibercept 8 mg.

  • The study is part of Regeneron’s ongoing clinical program to expand Eylea’s approved dosing into the 8 mg format.

  • Regeneron has two Phase 3 studies looking at the 8 mg dose in wet AMD, with early results expected in 1H of 2022.

  • On the safety front, after 16 weeks, 17% of patients receiving the 8 mg dose reported side effects compared with 22.6% on the 2 mg dose.

  • Two serious ocular side effects were reported, one in the 8 mg cohort and the other in the 2 mg cohort.

  • There were no instances of intraocular inflammation (including occlusive retinal vasculitis), anti-platelet trialists’ collaboration (APTC)-defined arterial thromboembolic events or deaths in either patient group.

  • Price Action: REGN shares are down 0.40% at $664.63 during the market session on the last check Tuesday.

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