Primary efficacy endpoint for pain met; primary efficacy endpoint
for inflammatory cells not attained
Safety data for both Phase 3 clinical trials showed no ocular or
treatment related serious adverse events
Conference call today at 5:00pm Eastern Time
BEDFORD, Mass.--(BUSINESS WIRE)--Apr. 6, 2015--
Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company
focused on the development and commercialization of innovative therapies
for diseases and conditions of the eye, today announced topline data
from the Company’s second of two Phase 3 clinical trials evaluating the
safety and efficacy of its lead product candidate, OTX-DP (Sustained
Release Dexamethasone, 0.4mg), for the treatment of ocular inflammation
and pain following cataract surgery and reported additional details from
the first Phase 3 clinical trial. The two primary efficacy endpoints for
the OTX-DP Phase 3 clinical trials were statistically significant
differences between the treatment group and the placebo group for the
absence of pain on day 8 and absence of inflammatory cells on day 14.
Both endpoints need to be met for the trials to be considered
successful. In the second Phase 3 clinical trial, OTX-DP met one of the
study’s two primary efficacy endpoints. In this trial, 77.5% of patients
receiving OTX-DP reported an absence of pain in the study eye on day 8
following insertion of the drug product, compared to 58.8% of those
receiving placebo vehicle control punctum plug, a difference which was
statistically significant (p=0.0025). 39.4% of OTX-DP-treated patients
showed an absence of inflammatory cells in the anterior chamber of the
study eye on day 14 following drug product insertion, compared to 31.3%
of those receiving placebo vehicle control punctum plug , a difference
which was not statistically significant (p=0.2182). Additionally, there
were a total of 240 patients enrolled in the second clinical trial, with
a 2:1 randomization of treated and control patients.
In March 2015, Ocular Therapeutix reported results from the Company’s
first Phase 3 clinical trial of OTX-DP, which enrolled 247 patients. In
this trial, OTX-DP met both primary efficacy endpoints, achieving a
statistically significant improvement in the reduction of inflammatory
cells on day 14 and pain on day 8. 33.7% of OTX-DP-treated patients
showed an absence of inflammatory cells in the anterior chamber of the
study eye on day 14 following drug product insertion, compared to 14.6%
of those receiving placebo vehicle control punctum plug (p=0.0015). In
addition, 76.1% of patients receiving OTX-DP reported absence of pain in
the study eye on day 8 following insertion of the drug product, compared
to 36.1% of those receiving placebo vehicle control punctum plug (p<
0.0001).
Topline safety results have been evaluated for the two Phase 3 clinical
trials of OTX-DP. There were no ocular or treatment related serious
adverse events in the OTX-DP treatment group in either of the two Phase
3 clinical trials. There were two serious adverse events in the OTX-DP
treatment group in the first Phase 3 trial (1.2% incidence), compared
with three serious adverse events in the placebo group (3.6% incidence).
There were two serious adverse events in the OTX-DP treatment group in
the second Phase 3 trial (1.3% incidence), compared with three serious
adverse events in the placebo group (3.8% incidence). Overall there were
fewer adverse events in the treated group than in the placebo group. The
Company expects to be able to use the safety data from these Phase 3
trials to support its other OTX-DP clinical development programs
including allergic conjunctivitis.
The secondary efficacy endpoints for the first Phase 3 clinical trial
have also been evaluated. Statistically significant differences were
seen for the absence of pain at days 2, 4, 14 and 30 in the OTX-DP
treatment group compared to the placebo group. Statistically significant
differences were seen for the absence of inflammatory cells at day 30 in
the OTX-DP treatment group compared to the placebo group, and there were
no statistically significant differences seen in the secondary endpoint
for absence of inflammatory cells at the other time points in the OTX-DP
treatment group in the first Phase 3 trial. Statistically significant
differences were seen for the absence of flare at day 8, day 14 and day
30 but not at day 2 or day 4. Data regarding secondary efficacy
endpoints for the second Phase 3 trial are still being evaluated.
“Following the favorable results from our first Phase 3 trial, we are
disappointed that the second Phase 3 clinical results for resolution of
inflammation did not have the same magnitude of differential as what
OTX-DP achieved in the first trial,” said Amar Sawhney, Ph.D., President
and CEO. “Although the efficacy results for the absence of inflammatory
cells in the OTX-DP treatment group met our expectations, the placebo
group response was significantly higher than expected. We have begun a
thorough analysis of the data from the second Phase 3 trial to fully
understand the difference in efficacy between these two trials that had
essentially the same trial design and similar patient populations. We
have examined the aggregate result on a post-hoc basis of the absence
and very minimal presence of inflammatory cells (defined as 0 and 0.5 on
a scale of 0 to 4.0) and the difference between the treatment and
placebo groups was found to be highly significant (66.3% in the
treatment group and 42.5% in the placebo group, p=0.0004).”
Dr. Sawhney continued, “We plan to meet with the FDA promptly to discuss
the Phase 3 OTX-DP clinical trial results and chart the appropriate path
forward. The safety data from these two trials further enhances the
safety profile of this product and will serve as a foundation for the
regulatory submissions for other indications with this product. We look
forward to advancing our OTX-DP and OTX-TP clinical development programs
to the next stage.”
OTX-DP is a product candidate placed in the canaliculus and designed to
deliver dexamethasone to the ocular surface for approximately four
weeks. Following treatment, OTX-DP resorbs and exits the nasolacrimal
system without need for removal. In March 2015, Ocular announced results
from its first Phase 3 trial of OTX-DP in post-operative ocular
inflammation and pain, which met both its primary efficacy endpoints,
with OTX-DP-treated patients achieving a statistically significant
improvement in the reduction of inflammatory cells and pain compared to
those receiving placebo. In November 2014, the Company announced
encouraging data from its Phase 2 clinical trial evaluating the safety
and efficacy of OTX-DP in allergic conjunctivitis, and the Company plans
to initiate Phase 3 clinical trials for this indication in the middle of
2015. The Company also initiated an exploratory Phase 2 clinical trial
of OTX-DP for the treatment of inflammatory dry eye in January 2015. The
Company is currently enrolling patients into a Phase 2b clinical trial
of its second sustained release product candidate, OTX-TP (Sustained
Release Travoprost), for the treatment of glaucoma and ocular
hypertension, and this trial is over 70% enrolled. Top-line efficacy
data from this trial is expected in the fourth quarter of 2015.
About the OTX-DP Post-Surgical Inflammation and Pain Clinical Trials
Two prospective, multicenter, randomized, parallel-arm, double-masked,
vehicle-controlled Phase 3 clinical trials were completed with a total
of 487 patients (247 patients in the first Phase 3 trial and 240
patients in the second Phase 3 trial) undergoing unilateral clear
corneal cataract surgery. Patients were randomized 2:1 to receive either
OTX-DP or a placebo vehicle control punctum plug without active drug.
Both primary efficacy endpoints, differences in the proportion of
patients in each treatment group with absence of cells in the anterior
chamber of the study eye, as measured using slit lamp examination, at
day 14 and absence of pain, as graded by a patient-reported score of
zero on a scale from zero to ten, at day 8 were recorded at each study
visit. Secondary efficacy endpoints were absence of flare in the
anterior chamber of the study eye at each evaluation date and absence of
inflammatory cells in the anterior chamber of the study eye and absence
of pain in the study eye at each evaluation date other than the day used
for the primary efficacy measure.
About Post- Surgical Ocular Inflammation and Pain
Ocular inflammation and pain are common side effects following
ophthalmic surgery. Physicians prescribe anti-inflammatory drugs, such
as corticosteroids, as the standard of care. If left untreated,
inflammation of the eye may result in further ocular complications,
including scarring and vision loss. Market Scope estimated approximately
5 million ocular surgeries were to have been performed in the United
States in 2014.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the
development and commercialization of innovative therapies for diseases
and conditions of the eye using its proprietary hydrogel platform
technology. Ocular Therapeutix's lead product candidates are in Phase 3
clinical development for post-surgical ocular inflammation and pain, and
Phase 2 clinical development for glaucoma, allergic conjunctivitis, and
dry eye disease. The Company is also evaluating sustained-release
injectable anti-VEGF drug depots for back-of-the-eye diseases. Ocular
Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal
corneal incisions following cataract surgery.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a live
conference call and webcast at 5:00 pm Eastern Time on April 6, 2015 to
discuss the results of the Phase 3 clinical trials evaluating OTX-DP for
the treatment of post-surgical inflammation and pain.
The live webcast and a replay may be accessed by visiting Ocular’s
website at investors.ocutx.com. Please connect to the Company's website
at least 15 minutes prior to the live webcast to ensure adequate time
for any software download that may be needed to access the webcast.
Alternatively, please call (844) 464-3934 (U.S.) or (765) 507-2620
(international) to listen to the live conference call. The conference ID
number for the live call is 22064396. Please dial in approximately 10
minutes prior to the call. Following the webcast, an archived version of
the call will be available for three months.
Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about the
development of the Company’s product candidates, such as plans to meet
with the FDA to discuss the path forward for OTX-DP for the treatment of
post-surgical ocular inflammation and pain, the ongoing development and
potential utility of OTX-DP for post-surgical ocular inflammation and
pain, the timing and conduct of the Company's Phase 2b clinical trial of
OTX-TP for the treatment of glaucoma and ocular hypertension and the
Company’s Phase 3 clinical trials of OTX-DP for allergic conjunctivitis,
the advancement of the Company's other product candidates and other
statements containing the words "anticipate," "believe," "estimate,"
"expect," "intend", "goal," "may", "might," "plan," "predict,"
"project," "target," "potential," "will," "would," "could," "should,"
"continue," and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors. Such forward-looking statements involve substantial
risks and uncertainties that could cause the Company’s clinical
development programs, future results, performance or achievements to
differ significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include, among
others, those related to the timing and costs involved in
commercializing ReSure® Sealant, the initiation
and conduct of clinical trials, availability of data from clinical
trials and expectations for regulatory approvals, the Company’s
scientific approach and general development progress, the availability
or commercial potential of the Company’s product candidates, the
sufficiency of cash resources and need for additional financing or other
actions and other factors discussed in the “Risk Factors” section
contained in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2014 on file with the Securities and Exchange Commission.
In addition, the forward-looking statements included in this press
release represent the Company’s views as of the date of this release.
The Company anticipates that subsequent events and developments will
cause the Company’s views to change. However, while the Company may
elect to update these forward-looking statements at some point in the
future, the Company specifically disclaims any obligation to do so.
These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the date
of this release.
Source: Ocular Therapeutix, Inc.
Investors:
Ocular Therapeutix, Inc.
Brad Smith
Chief
Financial Officer
bsmith@ocutx.com
or
Burns
McClellan on behalf of Ocular Therapeutix
Kimberly Minarovich,
212-213-0006
kminarovich@burnsmc.com
or
Media:
Scott
Corning
Vice President of Sales and Marketing
scorning@ocutx.com