Pivotal data
OZURDEX® achieved clinically meaningful improvements in vision in the 3-year pivotal trial1
Best corrected
visual acuity
outcomes
Outcomes in
pseudophakic
patients
Central retinal
thickness
outcomes
OZURDEX® patients (n=351)
The mean change in BCVA from baseline was +3.5 letters
with a mean of 4.1 injections over 3 years1
22.2% of patients with a ≥15-letter improvement in BCVA
from baseline to year 3 or final visit1
• p<0.001 vs sham (12% of patients with a ≥15-letter
improvement, n=350)
Clinically meaningful improvements in BCVA were
observed independent of lens status at baseline1
Pseudophakic OZURDEX® patients (n=86)
The mean change in BCVA from baseline was +6.5 letters1
• p<0.001 vs sham which achieved 1.7 letters, n=101
23.3% of patients with a ≥15-letter improvement in BCVA from
baseline to year 3 or final visit1
Mean reduction in CRT was -131.8 μm from baseline to 3 years1
• p<0.001 vs sham which achieved a -50.8 μm reduction, n=101
OZURDEX® patients (n=351)
Mean reduction in CRT from baseline (463 µm) to 3 years was -111.6 μm1
• p<0.001 vs sham which achieved a -41.9 μm reduction, n=350
Study details
Boyer D et al. 2014. Data from the pivotal MEAD study included two randomised, multicentre, masked sham-controlled, phase 3 trials with identical protocols conducted to evaluate the safety and efficacy of OZURDEX® in the treatment of patients with DME. 1,048 patients were randomised 1:1:1 to study treatment with OZURDEX® 0.7 mg (n=351), dexamethasone implant 0.35 mg (n=347) and sham (n=350). Patients were followed for three years (or 39 months for patients treated at Month 36) ≤40 scheduled visits. The primary endpoint was 15 letters improvement in BCVA from baseline. The results were pooled for analysis. The primary endpoint was achieved by 22.2% of OZURDEX® patients (p<0.001). Rates of cataract-related AEs in phakic eyes were 67.9% with OZURDEX®. Increases in IOP were usually controlled with medication or no therapy; only one patient (0.3%) treated with OZURDEX® required trabeculectomy due to steroid-induced IOP increase.1
Abbreviations and references
BCVA, best corrected visual acuity; CRT, central retinal thickness.
1. 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
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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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