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Two-year Results for Aflibercept 8 mg from Pivotal PHOTON Trial Demonstrate Durable Vision ...

FDA Issues Complete Response Letter (CRL) for Aflibercept 8 mg Biologics License Application ...

Two-year Results for Aflibercept 8 mg from Pivotal PHOTON Trial Demonstrate Durable Vision Gains at Extended Dosing Intervals in Diabetic Macular Edema

89% of all aflibercept 8 mg patients maintained ≥12-week dosing intervals through two years Of those assigned to a 16-week dosing regimen at baseline, 83% maintained ≥16-week dosing intervals through two years Many patients met the extension crite.

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Two-year Results for Aflibercept 8 mg from Pivotal PHOTON Trial Demonstrate Durable Vision Gains at Extended Dosing Intervals in Diabetic Macular Edema

Two-year Results for Aflibercept 8 mg from Pivotal PHOTON Trial Demonstrate Durable Vision Gains at Extended Dosing Intervals in Diabetic Macular Edema
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FDA Issues Complete Response Letter (CRL) for Aflibercept 8 mg Biologics License Application Solely Due to an Ongoing Review of Inspection Findings at a Third-party Filler

No issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in the CRL No additional clinical data or trials have been requested TARRYTOWN, N.Y., June 27, 2023 (GLOBE NEWSWIRE) Regeneron Ph.

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