randomized study of 153 patients with non-infectious uveitis affecting the posterior segment of the eye.
After a single injection, the percent of patients reaching a vitreous haze score of 0 (where a score of 0 represents no inflammation) was statistically significantly greater for patients receiving OZURDEX® versus sham at week 8 (primary time point) (47% versus 12%). The percent of patients achieving a 3-line improvement from baseline BCVA was 43% for patients receiving OZURDEX® versus 7% for sham at week 8.
Diabetic Macular Edema
The efficacy of OZURDEX® for the treatment of diabetic macular edema was assessed in two, multicenter, masked, randomized, sham-controlled studies. Subjects were to be eva luated for retreatment eligibility every three months starting from Month 6 but could only receive successive treatments at least 6 months apart. Retreatment was based on physician's discretion after examination including Optical Coherence Tomography. Patients in the OZURDEX® arm received an average of 4 treatments during the 36 months.
The primary endpoint was the proportion of patients with 15 or more letters improvement in BCVA from baseline at Month 39 or final visit for subjects who exited the study at or prior to Month 36. The Month 39 extension was included to accommodate the eva luation of safety and efficacy outcomes for subjects who received re-treatment at Month 36. Only fourteen percent of the study patients completed the Month 39 visit (16.8% from OZURDEX® and 12.2% from Sham).
Table 5: Visual Acuity outcomes at Month 39 (All randomized subjects with LOCFc)
aStudy 1: OZURDEX®, N=163; Sham, N=165
bStudy 2: OZURDEX®, N=165; Sham, N=163
c14% (16.8% from OZURDEX® and 12.2% from Sham) of patients had BCVA outcome at Month 39, for the remaining patients, the data at Month 36 or earlier was carried forward.
Study Outcomes OZURDEX® Sham
Estimated Difference (95% CI)
1a Mean (SD) Baseline BCVA (Letters) 56 (10)
57 (9)
Median (range) Baseline BCVA (Letters) 59 (34-95) 58 (34-74)
Gain of ≥15 letters in BCVA (n(%)) 34 (21%) 19 (12%) 9.3% (1.4%, 17.3%)
Loss of ≥15 letters in BCVA (n(%)) 15 (9%) 17 (10%) -1.1% (-7.5%, 5.3%)
Mean change in BCVA (SD) 4.1 (13.9) 0.9 (11.9) 3.2 (0.4, 5.9)
2b Mean (SD) Baseline BCVA (Letters) 55 (10)
56 (9)
Median (range) Baseline BCVA (Letters) 58 (34-72) 58 (36-82)
Gain of ≥15 letters in BCVA (n(%)) 30 (18%) 16 (10%) 8.4% (0.9%, 15.8%)
Loss of ≥15 letters in BCVA (n(%)) 30 (18%) 18 (11%) 7.1% (-0.5%, 14.7%)
Mean change in BCVA (SD) 0.4 (17.5) 0.8 (13.6) -0.7 (-4.1, 2.6)
Visual acuity outcomes by lens status (Phakic or Pseudophakic) at different visits are presented in FIGURE 2 and FIGURE 3. The occurrence of cataracts impacted visual acuity during the study. The visual acuity improvement from baseline increases during a treatment cycle, peaks at approximately 3 Months posttreatment and diminishes thereafter. Patients who were pseudophakic at baseline achieved greater mean BCVA change from baseline at the final study visit.
Figure 2: Proportion of Subjects with ≥ 15 Letters Improvement from Baseline BCVA in the Study Eye
Figure 2
Figure 3: Mean BCVA Change from Baseline
Figure 3
The best corrected visual acuity outcomes for the Pseudophakic a |
