nd Phakic subgroups from Studies 1 and 2 at Month 39 are presented in TABLE 6.
Table 6: Visual Acuity outcomes at Month 39 (Subgroup for pooled data with LOCFc)
a Pseudophakic: OZURDEX®, N=82; Sham, N=99
b Phakic: OZURDEX®, N=246; Sham, N=229
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 used in the analysis.
Subgroup
(Pooled) Outcomes OZURDEX® Sham
Estimated Difference (95% CI)
aPseudophakic Gain of ≥15 letters in BCVA (n(%)) 16 (20%) 11 (11%) 8.4%
(-2.2%, 19.0%)
Loss of ≥15 letters in BCVA (n(%)) 4 (5%) 7 (7%) -2.2% (-9.1%, 4.7%)
Mean change in BCVA (SD) 5.8 (11.6) 1.4 (12.3) 4.2 (0.8, 7.6)
Gain of ≥15 letters in BCVA (n(%)) 48 (20%) 24 (11%) 9.0% (2.7%, 15.4%)
bPhakic Loss of ≥15 letters in BCVA (n(%)) 41 (17%) 28 (12%) 4.4% (-1.9%, 10.7%)
Mean change in BCVA (SD) 1.0 (16.9) 0.6 (12.9) 0.3 (-2.4, 3.0) CLOSE
16 HOW SUPPLIED/STORAGE AND HANDLING
OZURDEX® (dexamethasone intravitreal implant) 0.7 mg is supplied in a foil pouch with 1 single-use plastic applicator, NDC 0023-3348-07.
Storage: Store at 15°-30°C (59°-86°F).
17 PATIENT COUNSELING INFORMATION
Steroid-related Effects
Advise patients that a cataract may occur after repeated treatment with OZURDEX®. If this occurs, advise patients that their vision will decrease, and they will need an operation to remove the cataract and restore their vision.
Advise patients that they may develop increased intraocular pressure with OZURDEX® treatment, and the increased IOP will need to be managed with eye drops, and, rarely, with surgery.
Intravitreal Injection-related Effects
Advise patients that in the days following intravitreal injection of OZURDEX®, patients are at risk for potential complications including in particular, but not limited to, the development of endophthalmitis or elevated intraocular pressure.
When to Seek Physician Advice
Advise patients that if the eye becomes red, sensitive to light, painful, or develops a change in vision, they should seek immediate care from an ophthalmologist.
Driving and Using Machines
Inform patients that they may experience temporary visual blurring after receiving an intravitreal injection. Advise patients not to drive or use machines until this has been resolved.
© 2014 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® marks owned by Allergan, Inc.
Patented. See: www.allergan.com/products/patent_notices
Made in Ireland.
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PRINCIPAL DISPLAY PANEL
Ozurdex ®
(dexamethasone
intravitreal implant) 0.7 mg
Contents include:
One Sterile, Single-Use Applicator
NDC 0023-3348-07
For Intravitreal Injection Only
Rx only
ALLERGAN
One Sterile, Single-Use Applicator
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INGREDIENTS AND APPEARANCE
OZURDEX
dexamethasone implant
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-3348
Route of Administration INTRAVITREAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
dexamethasone (UNII: 7S5I7G3JQL) (dexamethasone - UNII:7S5I7G3JQL) dexamethasone 0.7 mg
PACKAGING
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