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Ozurdex

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Ozurdex

Ozurdex

CLINICAL PHARMACOLOGY

Mechanism Of Action

Dexamethasone, a potent corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.

Pharmacokinetics

Plasma concentrations were obtained from 21 patients in two 6 month studies prior to dosing and on Days 1, 7, 30, 60, and 90 following the intravitreal implant containing 0.35 mg or 0.7 mg dexamethasone. In both studies, the majority of plasma dexamethasone concentrations were below the lower limit of quantitation (LLOQ = 50 pg/mL). Plasma dexamethasone concentrations from 10 of 73 samples in the 0.7 mg dose group and from 2 of 42 samples in the 0.35 mg dose group were above the LLOQ, ranging from 52 pg/mL to 94 pg/mL. The highest plasma concentration value of 94 pg/mL was observed in one subject from the 0.7 mg group. Plasma dexamethasone concentration did not appear to be related to age, body weight, or sex of patients.

In an in vitro metabolism study, following the incubation of [14C]-dexamethasone with human cornea, iris-ciliary body, choroid, retina, vitreous humor, and sclera tissues for 18 hours, no metabolites were observed.

Clinical Studies

Retinal Vein Occlusion

The efficacy of OZURDEX® for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) was assessed in two, multicenter, double-masked, randomized, parallel studies.

Following a single injection, OZURDEX® demonstrated the following clinical results for the percent of patients with ≥ 15 letters of improvement from baseline in best-corrected visual acuity (BCVA):

Number (Percent) of Patients with ≥ 15 Letters Improvement from Baseline in BCVA

Study Day Study 1 Study 2
DEX 700
N=201
Sham
N=202
p-value* DEX 700
N=226
Sham
N=224
p-value*
Day 30 40 (20%) 15 (7%) < 0.01 51 (23%) 17 (8%) < 0.01
Day 60 58 (29%) 21 (10%) < 0.01 67 (30%) 27 (12%) < 0.01
Day 90 45 (22%) 25 (12%) < 0.01 48 (21%) 31 (14%) 0.039
Day 180 39 (19%) 37 (18%) 0.78 53 (24%) 38 (17%) 0.087
*P-values were based on the Pearson's chi-square test.

In each individual study and in a pooled analysis, time to achieve ≥ 15 letters (3-line) improvement in BCVA cumulative response rate curves were significantly faster with OZURDEX®compared to sham (p < 0.01), with OZURDEX® treated patients achieving a 3­line improvement in BCVA earlier than sham-treated patients.

The onset of a ≥ 15 letter (3-line) improvement in BCVA with OZURDEX® occurs within the first two months after implantation in approximately 20-30% of subjects. The duration of effect persists approximately one to three months after onset of this effect.

Posterior Segment Uveitis

The efficacy of OZURDEX® was assessed in a single, multicenter, masked, 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.

Last reviewed on RxList: 2/20/2014
This monograph has been modified to include the generic and brand name in many instances.

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