Reason for request

Extension of inclusion

Minor improvement, as is the case with LUCENTIS, in the treatment of visual impairment due to diabetic macular oedema

 

  • EYLEA now has Marketing Authorisation in the treatment of visual impairment due to diabetic macular oedema (DME) in adults.

  • Its efficacy versus laser photocoagulation has been demonstrated. The observed differences versus ranibizumab in the change in BCVA, although statistically significant, are not clinically relevant.

  • As is the case with LUCENTIS, the therapeutic benefit provided by EYLEA in the treatment of visual impairment due to DME is minor in the diffuse form or in lesions close to the centre of the macula in patients with visual acuity less than or equal to 5/10 in whom management of diabetes has been optimised.

 

 


Clinical Benefit

Substantial

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Insufficient

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Clinical Added Value

minor

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Therapeutic use

-

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