he analysis of ETDRS-DRSS at week 100 in the VIVID and VISTA studies are shown in TABLE 8 below.
Table 8: Proportion of Patients who Achieved a ≥2-Step Improvement from Baseline in the ETDRS-DRSS Score at Week 100 (LOCF*) in VIVID and VISTA Studies
VIVID VISTA
EYLEA
2 mg Q8 weeks † EYLEA
2 mg Q4 weeks Control EYLEA
2 mg Q8 weeks † EYLEA
2 mg Q4 weeks Control
eva luable Patients‡ N=101 N=97 N=99 N=148 N=153 N=150
* Non-gradable post-baseline ETDRS-DRSS values were treated as missing and were imputed using the last gradable ETDRS-DRSS values (including baseline values if all post-baseline values were missing or non-gradable) † After treatment initiation with 5 monthly injections ‡ The number of eva luable patients included all patients who had valid ETDRS-DRSS data at baseline § Difference with confidence interval (CI) was calculated using Mantel-Haenszel weighting scheme adjusted by protocol specified stratification factors ¶ Difference is EYLEA minus Control group # p<0.01 compared with Control
Number of patients with a ≥2-step improvement on ETDRS-DRSS from Baseline (%) 32
(32%) 27
(28%) 7
(7%) 56
(38%) 58
(38%) 24
(16%)
Difference§, ¶(%)
(97.5% CI) 24%#
(12, 36) 21%#
(9, 33) 22%#
(11, 33) 22%#
(11, 33)
Results of the eva luable subgroups (e.g., age, gender, race, baseline HbA1c, baseline visual acuity) on the proportion of patients who achieved a ≥2-step improvement on the ETDRS-DRSS from baseline to week 100 were, in general, consistent with those in the overall population.
16 HOW SUPPLIED/STORAGE AND HANDLING
Each Vial is for single eye use only. EYLEA is supplied in the following presentation [see DOSAGE AND ADMINISTRATION (2.6) and (2.7)].
NDC NUMBER CARTON TYPE CARTON CONTENTS
61755-005-02 Vial one single-use, sterile, 3-mL, glass vial designed to deliver 0.05 mL of 40 mg/mL EYLEA
one 19-gauge × 1½-inch, 5-micron, filter needle for withdrawal of the vial contents
one 30-gauge × ½-inch injection needle for intravitreal injection
one 1-mL syringe for administration
one package insert
Storage
EYLEA should be refrigerated at 2°C to 8ºC (36°F to 46ºF). Do Not Freeze. Do not use beyond the date stamped on the carton and container label. Protect from light. Store in the original carton until time of use.
17 PATIENT COUNSELING INFORMATION
In the days following EYLEA administration, patients are at risk of developing endophthalmitis or retinal detachment. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise patients to seek immediate care from an ophthalmologist [see WARNINGS AND PRECAUTIONS (5.1)].
Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA and the associated eye examinations [see ADVERSE REACTIONS (6)]. Advise patients not to drive or use machinery until visual function has recovered sufficiently.
SPL UNCLASSIFIED SECTION
REGENERON
Manufactured by:
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591-6707
U.S. License Number 1760
EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc.
© 2016, Regeneron Pharmaceuticals, Inc.
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