Bayer announced today that the Drug Evaluation Center (DEC) of China's National Medical Products Administration (NMPA) has agreed to review an application for regulatory approval of aflibercept 8 mg for the treatment of neovascular (wet) age-related macular degeneration (AMD).

The study data are currently under review by the Chinese regulatory authority.

The application is based on positive results from a Phase III trial showing that aflibercept 8 mg met its primary endpoint of non-inferiority in terms of best change in corrected visual acuity (BCVA) compared with Eylea (aflibercept 2 mg).

At week 48 of the trial, aflibercept 8 mg, administered with extended treatment intervals (every 12 or 16 weeks), demonstrated visual acuity comparable to that of standard Eylea (aflibercept 2 mg) with a fixed treatment interval of 8 weeks, after three initial monthly doses.

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