Press Release
Ocular Therapeutix™ Announces Additional Successful Results for Phase 3 Clinical Trial of DEXTENZA™
Statistically significant secondary endpoint of absence of ocular flare confirms further evidence of reduction of inflammation
The secondary endpoint, the absence of anterior chamber (AC) flare, an indicator of inflammation, was statistically superior to placebo at all measured time points. Approximately 46% of patients in the DEXTENZA treatment group were shown to have an absence of AC flare at day 4 after insertion, which Ocular believes provides further support of the early onset anti-inflammatory effect of DEXTENZA. Additional secondary efficacy endpoints included differences in the absence of AC cells and ocular pain on days 2, 4, 14, and 30 after insertion. As previously reported, all of these secondary endpoints were met with statistical significance with the exception of the endpoint for the absence of AC cells at day 2.
As also previously announced, DEXTENZA successfully met the trial’s two primary efficacy endpoints, absence of ocular pain on day 8 and absence of ocular inflammation on day 14 when compared to placebo. In this Phase 3 clinical trial, for which the complete safety assessment will be available in the first quarter of 2017, no treatment-related serious adverse events were observed. DEXTENZA has exhibited a favorable safety profile and has been well tolerated in all clinical trials, regardless of indication.
“The positive results for the secondary endpoint of absence of ocular
flare build upon the successful topline results from this trial which we
announced last month,” said
Summary of Efficacy Results from Third Phase 3 Trial of DEXTENZA for the Treatment of Post-Surgical Ocular Inflammation and Pain
Visit | ||||||||||||
Efficacy Endpoint | Day 2* | Day 4 | Day 8 | Day 14 | Day 30 | |||||||
Proportion of patients with an absence of AC cells |
DEXTENZA Group |
1.9%*** |
14.1%
(P<0.05) |
29.1%
(P<0.0001) |
52.1%**
(P<0.0001) |
81.0%
(P<0.0001) |
||||||
Placebo Group | 2.3% | 7.7% | 11.7% | 31.2% | 63.3% | |||||||
Proportion of patients with an absence of ocular pain |
DEXTENZA Group |
73.0%
(P<0.0001) |
76.5%
(P<0.0001) |
79.3%**
(P<0.0001) |
84.2%
(P<0.0001) |
89.1%
(P<0.05) |
||||||
Placebo Group |
56.8% | 61.1% | 61.3% | 70.1% | 80.0% | |||||||
Proportion of patients with an absence of AC flare |
DEXTENZA Group |
28.8%
(P<0.05) |
46.0%
(P<0.05) |
58.2%
(P<0.0001) |
73.5%
(P<0.0001) |
90.0%
(P<0.05) |
||||||
Placebo Group | 19.8% | 29.4% | 36.9% | 49.3% | 79.5% |
*Day following insertion
**Primary endpoints of trial; both primary
efficacy endpoints were achieved
*** Did not achieve statistical
significance; all other efficacy endpoints were achieved
Phase 3 Study Design
This prospective, multicenter, 1:1
randomized, parallel-arm, double-masked, vehicle-controlled study was
designed to evaluate the safety and efficacy of DEXTENZA for the
treatment of ocular inflammation and pain following ophthalmic surgery.
The study enrolled 438 patients who were undergoing clear corneal
cataract surgery at 21 sites throughout
This was the third Phase 3 clinical trial that the Company has conducted
with DEXTENZA for the treatment of ocular inflammation and pain
following ophthalmic surgery. Independent of the results of this third
trial and based on the results from the first two Phase 3 clinical
trials,
About Ocular Pain and Inflammation Following Ophthalmic Surgery
Ocular
pain and inflammation are common side effects following ophthalmic
surgery. Physicians prescribe topical corticosteroids as part of the
standard of post-operative care. If left untreated, inflammation of the
eye may result in further ocular complications, which in some cases, may
cause permanent loss of vision. According to US Census data, by the year
2020, it is estimated that the number of Americans diagnosed with
cataracts is expected to rise to approximately 30 million, representing
a 32% increase over current prevalence estimates. Approximately 3.8
million cataract cases were performed in
About
Forward Looking Statements
Any statements in this press
release about future expectations, plans and prospects for the Company
including the development and regulatory status of the Company’s product
candidates, such as the Company’s expectations and plans regarding
regulatory submissions for and the timing and conduct of clinical trials
of DEXTENZA™ for the treatment of post-surgical ocular inflammation and
pain, including our expectations regarding the NDA filed with the
View source version on businesswire.com: http://www.businesswire.com/news/home/20170104005445/en/
Source:
Investors
Ocular Therapeutix, Inc.
Brad Smith
Chief
Financial Officer
bsmith@ocutx.com
or
Burns
McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
sklass@burnsmc.com
or
Media
Medical
Dynamics
Cynthia Sutherland, 646-599-8635
Media Group Director
csutherland@rxmedyn.com