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Home Industry News Bayer HealthCare applies for EU VEGF Trap-Eye approval

Bayer HealthCare applies for EU VEGF Trap-Eye approval

13th June 2011

Bayer HealthCare has applied for European regulatory approval of VEGF Trap-Eye as a treatment for the neovascular form of age-related macular degeneration (wet AMD).

In partnership with Regeneron Pharmaceuticals, the company has submitted an application to the European Medicines Agency, which is supported by data from two phase III clinical trials.

During these studies, the treatment was able to meet its primary efficacy endpoint of non-inferiority to a monthly 0.5 mg dose of ranibizumab, the current standard of care.

Should this prove successful, Bayer would be responsible for the European marketing of the drug, while Regeneron retains exclusive rights to sell the treatment in the US.

Dr Kemal Malik, head of global development and member of the Bayer HealthCare executive committee, said: "We look forward to working closely with the European regulatory authority to bring this new medicine to patients with wet AMD."

Earlier this year, Bayer and Regeneron initiated a new phase III study that will evaluate the drug as a diabetic macular oedema treatment.ADNFCR-8000103-ID-800576107-ADNFCR

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