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Archived: dexamethasone (Ozurdex)

Advice

following a resubmission: 

dexamethasone intravitreal implant (Ozurdex®) is not recommended for use within NHS Scotland. 

Indication under review: treatment of adult patients with macular oedema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). 

In two phase III studies dexamethasone 700 microgram intravitreal implant was superior to sham administration at day 90 for the proportion of patients with a best corrected visual acuity improvement of 15 letters.  Longer-term effectiveness of treatment is uncertain. 

The submitting company did not provide a sufficiently robust clinical and economic analysis to gain acceptance by SMC.  

The licence holder has indicated their intention to resubmit.

Drug Details

Drug Name: dexamethasone (Ozurdex)
SMC Drug ID: 652/10
Manufacturer: Allergan Ltd
Indication: For the treatment of macular oedema following RVO.
BNF Category:
Sub Category: 11.4 Corticosteroids and other anti-inflammatory preparations
Submission Type: Resubmission
Status: Not Recommended
Date Advice Published: 12 December 2011

Current Advice

Resubmission 11 June 2012

Archived Advice

Full submission 13 December 2010

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