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OZURDEX (dexamethasone), corticosteroid

OPHTHALMOLOGY - New indication
Opinions on drugs - Posted on Sep 10 2015

Reason for request

Extension of indication

No clinical benefit demonstrated in the treatment of visual impairment secondary to diabetic macular oedema:

- compared with LUCENTIS in pseudophakic patients and

- compared with the usual management in patients with an inadequate response to non-corticosteroid treatment and for whom corticosteroid treatment is not suitable.

  • OZURDEX has Marketing Authorisation in the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.
  • In these patients, this medicinal product is useful only when the impairment of visual acuity is less than or equal to 5/10 and in whom management of diabetes has been optimised.
  • Its effects are small and it has not been compared with photocoagulation or with anti-VEGFs, which are the first-line treatments for visual impairment secondary to DME.
  • OZURDEX is a second-line treatment.



 


Clinical Benefit

Moderate

-

Insufficient

Clinical Added Value

no clinical added value

-


Therapeutic use

-

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