cular adverse reactions are shown in TABLES 2 and 3:
Table 2: Ocular Adverse Reactions Reported by ≥ 1% of Patients and Non-ocular Adverse Reactions Reported by ≥ 5% of Patients
1 Includes cataract, cataract nuclear, cataract subcapsular, lenticular opacities in patients who were phakic at baseline. Among these patients, 61% of OZURDEX® subjects vs. 8% of sham-controlled subjects underwent cataract surgery.
2 243 of the 324 OZURDEX® subjects were phakic at baseline; 230 of 328 sham-controlled subjects were phakic at baseline.
MedDRA Term
OZURDEX®
N=324 (%) Sham
N=328 (%)
Ocular
Cataract1 166/2432 (68%) 49/230 (21%)
Conjunctival hemorrhage 73 (23%) 44 (13%)
Visual acuity reduced 28 (9%) 13 (4%)
Conjunctivitis 19 (6%) 8 (2%)
Vitreous floaters 16 (5%) 6 (2%)
Conjunctival edema 15 (5%) 4 (1%)
Dry eye 15 (5%) 7 (2%)
Vitreous detachment 14 (4%) 8 (2%)
Vitreous opacities 11 (3%) 3 (1%)
Retinal aneurysm 10 (3%) 5 (2%)
Foreign body sensation 7 (2%) 4 (1%)
Corneal erosion 7 (2%) 3 (1%)
Keratitis 6 (2%) 3 (1%)
Anterior Chamber Inflammation 6 (2%) 0 (0%)
Retinal tear 5 (2%) 2 (1%)
Eyelid ptosis 5 (2%) 2 (1%)
Non-ocular
Hypertension 41 (13%) 21 (6%)
Bronchitis 15 (5%) 8 (2%)
Increased Intraocular Pressure
Table 3: Summary of Elevated Intraocular Pressure (IOP) Related Adverse Reactions
* OZURDEX®: 1 surgical trabeculectomy for steroid-induced IOP increase, 1 surgical trabeculectomy for iris neovascularization,
1 laser iridotomy, 1 surgical iridectomy
Sham: 1 laser iridotomy
IOP Treatment: N (%)
OZURDEX®
N=324 Sham
N=328
IOP elevation ≥10 mm Hg from Baseline at any visit 91 (28%) 13 (4%)
≥30 mm Hg IOP at any visit 50 (15%) 5 (2%)
Any IOP lowering medication 136 (42%) 32 (10%)
Any surgical intervention for elevated IOP * 4 (1.2%) 1 (0.3%)
The increase in mean IOP was seen with each treatment cycle, and the mean IOP generally returned to baseline between treatment cycles (at the end of the 6 month period) shown below:
Figure 1: Mean IOP during the study
Figure 1
Cataracts and Cataract Surgery
At baseline, 243 of the 324 OZURDEX® subjects were phakic; 230 of 328 sham-controlled subjects were phakic. The incidence of cataract development in patients who had a phakic study eye was higher in the OZURDEX® group (68%) compared with Sham (21%). The median time of cataract being reported as an adverse event was approximately 15 months in the OZURDEX® group and 12 months in the Sham group. Among these patients, 61% of OZURDEX® subjects vs. 8% of sham-controlled subjects underwent cataract surgery, generally between Month 18 and Month 39 (Median Month 21 for OZURDEX® group and 20 for Sham) of the studies.
6.2 Postmarketing Experience
The following reactions have been identified during post-marketing use of OZURDEX® in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to OZURDEX®, or a combin |
