Biomedical Engineering Reference
In-Depth Information
was the time to achieve a
15-letter improvement in best-corrected
visual acuity (BCVA); secondary efficacy outcomes included the
percentage of patients achieving
15-letter (3-line) improvement
in BCVA, mean change in BCVA, and central retinal thickness.
In each study and in the pooled analysis, Ozurdex
®
achieved its
primary endpoint; the time to achieve a
15 letter improvement in
BCVA cumulative response rate curves were significantly faster
with Ozurdex
®
as compared with a sham procedure (
P
0.001).
The secondary efficacy measures also supported the efficacy of
Ozurdex
®
, as the percentage of patients achieving
<
15-letters of
improvement in BCVA at day 90 was 22 % with Ozurdex
®
and 13 %
with sham (
P
0.001) [
39
]. Benefits were similar following a
second treatment 6 months after the first [
40
]. The most common
adverse effect associated with Ozurdex
®
was increased IOP (per-
centage with IOP
<
25 mmHg: 16 % vs.
1 % in the sham group;
<
0.001) [
39
]. Phakic eyes treated with a second Ozurdex
®
implant also had an increased risk of cataract progression (30 % vs.
6 % for sham)—although the rate of cataract surgery was similar to
that for sham (1.3 % vs. 1.1 % for sham) [
40
]. The rate of all other
adverse events were similar between Ozurdex
®
-treated and sham-
treated eyes [
39
,
40
].
Marketing approval for the uveitis indication was based on a
single, multicenter, masked, 26-week, randomized, sham-controlled
study of 153 patients; the c
H
ronic
U
veitis evaluation of the int
R
a-
vitreal dexamethas
ON
e implant (HURON) trial [
41
]. It should
be noted that intermediate and posterior uveitis are both rare, so
it is appropriate that only a single, small study was conducted for
this additional indication. The primary outcome measure was the
proportion of eyes with a vitreous haze score of 0 at week 8. The
proportion of eyes that achieved this primary endpoint was sig-
nificantly greater with Ozurdex
®
treatment (47 %) than with the
sham procedure (12 %;
P
P
<
0.001) and the benefits persisted
through week 26. In addition, the percentage of eyes achieving
<
15-letters of improvement in BCVA at day 90 was two- to
sixfold greater with Ozurdex
®
than with sham throughout the
follow-up
period.
Increased IOP (percentage with IOP
25 mmHg: 7.1 % vs. 4.2 %) and an increased risk of cataract
(15 % vs. 7 % for sham) were more common with Ozurdex
®
treatment than sham treatment, but these differences were not
statistically significant (
P
>
0.05) [
41
].
In the US, Ozurdex
®
was granted a Fast Track Designation by the
FDA for the BRVO/CRVO indication and a priority review [
36
].
It should be noted that, at the time Ozurdex
®
was submitted for
marketing authorization, no approved treatment had been shown
to improve vision in eyes with RVO. The FDA concluded that the
NDA submitted supported the safety and efficacy of Ozurdex
®
for this indication. The studies demonstrated that the efficacy of
4.1 US Approvals
