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Ozurdex

SIDE EFFECTS

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adverse reactions associated with ophthalmic steroids including OZURDEX® include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.

Retinal Vein Occlusion and Posterior Segment Uveitis

The following information is based on the combined clinical trial results from 3 initial, randomized, 6-month, sham-controlled studies (2 for retinal vein occlusion and 1 for posterior segment uveitis):

Table 1: Adverse Reactions Reported by Greater than 2% of Patients

MedDRA Term OZURDEX®
N=497 (%)
Sham
N=498 (%)
Intraocular pressure increased 125 (25%) 10 (2%)
Conjunctival hemorrhage 108 (22%) 79 (16%)
Eye pain 40 (8%) 26 (5%)
Conjunctival hyperemia 33 (7%) 27 (5%)
Ocular hypertension 23 (5%) 3 (1%)
Cataract 24 (5%) 10 (2%)
Vitreous detachment 12 (2%) 8 (2%)
Headache 19 (4%) 12 (2%)

Increased IOP with OZURDEX® peaked at approximately week 8. During the initial treatment period, 1% (3/421) of the patients who received OZURDEX® required surgical procedures for management of elevated IOP.

Following a second injection of OZURDEX® in cases where a second injection was indicated, the overall incidence of cataracts was higher after 1 year.

Diabetic Macular Edema

The following information is based on the combined clinical trial results from 2 randomized, 3­year, sham-controlled studies in patients with diabetic macular edema. Discontinuation rates due to the adverse reactions listed in Table 2 were 3% in the OZURDEX® group and 1% in the Sham group. The most common ocular (study eye) and non-ocular adverse reactions are as follows:

Table 2: Adverse Reactions Reported by ≥ 1% of Patients

MedDRA Term OZURDEX®
N=324 (%)
Sham
N=328 (%)
Ocular
Cataract1 166/2432 (68%) 49/230 (21%)
Intraocular pressure increased3 115 (35%) 16 (5%)
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%)
1Includes 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.
2243 of the 324 OZURDEX®subjects were phakic at baseline; 230 of 328 sham-controlled subjects were phakic at baseline.
3Includes IOP increased and ocular hypertension.

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.

Increased Intraocular Pressure

Table 3: Summary of Elevated IOP Related Adverse Reactions

IOP Treatment: N (%)
OZURDEX®
N=324
Sham
N=328
Any IOP Related AE 120 (37%) 18 (6%)
≥ 10 mm Hg IOP Change from Baseline at any visit 91 (28%) 13 (4%)
≥ 25 mm Hg IOP at any visit 106 (33%) 15 (5%)
≥ 35 mm Hg IOP at any visit 20 (6%) 3 (1%)
Glaucoma 4 (1.2%) 1 (0.3%)
IOP lowering procedure* 4 (1.2%) 1 (0.3%)
* 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

Approximately 42% of the patients who received OZURDEX® were subsequently treated with IOP lowering medications during the study . In the sham control group, IOP lowering medications were used in approximately 10% of patients.

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

Mean IOP during the study - Illustration

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 combination of these factors, include: complication of device insertion (implant misplacement), device dislocation with or without corneal edema, endophthalmitis, hypotony of the eye (associated with vitreous leakage due to injection), and retinal detachment.

Read the Ozurdex (dexamethasone intravitreal implant) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No information provided.

Read the Ozurdex Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 7/14/2014
This monograph has been modified to include the generic and brand name in many instances.

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