Sirion Therapeutics, Inc., a
privately held ophthalmic-focused biopharmaceutical company, announced the presentation of data from two Phase 3 clinical trials of
Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a topical steroid in
the treatment of postoperative ocular inflammation. The results were given
in a presentation by Michael Korenfeld, MD during the American Society of
Cataract and Refractive Surgery Annual Symposium in Chicago, Illinois.
The two multi-center studies evaluated the safety and efficacy of
Durezol(TM) 0.05% compared to placebo dosed twice a day (BID) and four
times a day (QID) beginning 24 hours after ocular surgery. The studies
included 438 subjects who presented with an anterior chamber cell grade 2
(greater than or equal to 10 cells) or higher the day after surgery. The
clinically and statistically significant findings demonstrated that
Durezol(TM), at both the BID and QID dosing regimens, was superior to
placebo in achieving the primary endpoint of proportion of subjects with an
anterior chamber cell grade of 0 (less than or equal to 1 cell) on Day 8,
with 30% of subjects in the BID group reaching Grade 0 versus 9% in the
placebo group. Of the subjects in the QID group, 35% reached Grade 0 on Day
8. In addition, Durezol(TM) maintained superiority over placebo through the
treatment period (Day 15), with 56% in the BID group and 63% in the QID
group reaching Grade 0 versus 16% in the placebo group.
Further data from the presentation demonstrated that both the BID and
QID dosing regimens were superior to placebo with regard to change from
baseline in anterior chamber cell count at Day 8. The mean reduction in
cell count for subjects in both the BID and QID groups was 19 cells and the
mean reduction in the placebo group was 6 cells. In addition, the
proportion of subjects who reached “clinical cure” (defined as anterior
chamber cell count less than or equal to 5 and flare score of 0) at Day 15
was 73% in the BID group and 71% in the QID group versus 27% in the placebo
group (p