Safety profile
OZURDEX® has a predictable and manageable
safety profile1-3
OZURDEX® has
over 1 million
estimated patient
years of
experience*1
IOP rises are
typically transient,
moderate and
manageable with
IOP medications2,3
Cataract-related
adverse events2,3
*Based on worldwide distribution and estimated patient exposure of Ozurdex® for the period 01 June 2009 – 31 January 2022.
The most commonly reported adverse events following treatment with OZURDEX® are those frequently observed with ophthalmic steroid treatment or intravitreal injections, such as:2
• Elevated intraocular pressure (IOP)
• Cataract formation
• Conjunctival or vitreal haemorrhage
Less frequently reported, but more serious, adverse reactions include endophthalmitis, necrotising retinitis, retinal detachment and retinal tear. This is not an exhaustive list of adverse events. For additional safety information please refer to the OZURDEX® SPC.2
Abbreviations and references
IOP, intraocular pressure.
1. AbbVie data on file. ALL-OZU-003557. April 2022.
2. OZURDEX® SPC.
3. Boyer D et al. Ophthalmology 2014; 121(10): 1904-14.
Job Number ALL-OZU-220048. Date of Preparation March 2023
OZURDEX® (dexamethasone intravitreal implant) is indicated for the treatment of adult patients with:
- Visual impairment due to diabetic macular edema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy
- Macular edema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
- Inflammation of the posterior segment of the eye presenting as non-infectious uveitis
Adverse events should be reported. Reporting forms and information can be found at XXXX
Adverse events should also be reported to AbbVie on GVPV@abbvie.com
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Additional info
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Job Number ALL-OZU-220048. Date of Preparation March 2023. This website has been developed and funded by AbbVie Ltd.
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In the pivotal MEAD study OZURDEX® patients (n=347)
- Mean IOP increase from baseline did not exceed 3.2 mmHg, peaked at 1.5 months after each injection and returned to approximately baseline by month 6 following each injection2
- 42% of patients required IOP-lowering medications in the study eye at some stage during the 3 year studies2
Cataract-related adverse events (including cataract cortical, cataract diabetic, cataract nuclear, cataract subcapsular, cataract lenticular, cataract) developed in 67.9% of phakic eyes (n=265) with 59.2% requiring cataract surgery by Year 3 of the pivotal MEAD study3
At baseline 87.0% of patients with a phakic study eye treated with OZURDEX® had some degree of lens opacification/early cataract2
