Press Release
Ocular Therapeutix™ Announces Topline Results of Phase 3 Clinical Trial for DEXTENZA™ for the Treatment of Allergic Conjunctivitis
DEXTENZA successfully met primary endpoint for treatment of ocular itching associated with allergic conjunctivitis
Conference call today at
Treatment success was evaluated separately in this trial for ocular
itching and conjunctival redness, and attainment of endpoints for both
ocular itching and conjunctival redness has not been historically
required by the
The primary endpoint of treatment of ocular itching associated with allergic conjunctivitis was successfully achieved in this trial. There was a statistically significant difference (p<0.0001) in the mean scores between the DEXTENZA treatment group and the placebo group for ocular itching at all three time points measured on day 7 post-insertion of the drug product. The difference in the scores for ocular itching between the DEXTENZA group and the placebo group was greater than 0.5 units at all time points on day 7 post-insertion and was greater than 1 unit at a majority of the time points on day 7 post-insertion.
The primary endpoint of conjunctival redness is typically an endpoint included in Phase 3 trials for allergic conjunctivitis but has not been required for approval. The DEXTENZA treatment group did not achieve the primary endpoints for conjunctival redness in this trial. Many commercially available prescription medications for the treatment of allergic conjunctivitis have an ocular itching indication only. In this clinical trial, as well as other clinical trials completed to date, DEXTENZA has exhibited a strong safety profile and has been well tolerated.
“We are very pleased with the results of this Phase 3 clinical trial in
terms of the treatment of ocular itching associated with allergic
conjunctivitis,” stated
Phase 3 Study Design
The Phase 3 U.S.-based, multicenter, 1:1 randomized, parallel-arm,
double-masked, vehicle-controlled trial in 73 patients was designed to
evaluate the safety and efficacy of DEXTENZA™ (sustained release
dexamethasone) 0.4mg, Intracanalicular Depot for the treatment of the
signs and symptoms of allergic conjunctivitis. This is the first of two
planned Phase 3 studies to be conducted by
The study was designed to assess the effect of DEXTENZA compared with a placebo drug delivery vehicle on allergic reactions using four series of successive allergen challenges over a 30-day period. According to the trial design, DEXTENZA or placebo was administered 48 to 72 hours after final confirmatory exposure to the allergen. The primary efficacy endpoints evaluated were the differences in mean scores in ocular itching and conjunctival redness between the treatment group and the placebo group at 7 days following insertion of the drug product.
About Allergic Conjunctivitis
Allergic conjunctivitis is an inflammatory disease of the conjunctiva
resulting primarily from a reaction to allergy-causing substances such
as pollen or pet dander. The primary sign of this inflammation is
conjunctival redness, and the primary symptom is acute ocular itching.
Allergic conjunctivitis ranges in clinical severity from relatively
mild, common forms to more severe forms that can cause impaired vision.
According to a study on the management of seasonal allergic
conjunctivitis published in 2012 in the peer-reviewed journal
About the Modified Conjunctival Allergen Challenge Model
The modified Ora-CAC® model used in the recently completed study has been developed to study the interactions between the early and late phases of the allergic response in the eye, and to evaluate the effects of pharmaceutical intervention. The modified Ora-CAC model utilizes four challenges conducted over a 2-day interval to evaluate the effectiveness of a test agent to prevent an acute ocular allergic reaction, as well as evaluate the test agent’s ability to prevent an acute ocular allergic reaction in the presence of subclinical late phase inflammation.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 5:00 pm Eastern Time. The live webcast can be accessed by visiting the investor section of the Company’s website at investors.ocutx.com. Please connect 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 conference call. The conference ID number for the live call will be 66607929. An archive of the webcast will be available until November 5, 2015 on the company’s website.
About Ocular Therapeutix, Inc.
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 the ongoing
development and potential utility of OTX-DP for allergic conjunctivitis
and the timing and conduct of the Company’s second Phase 3 clinical
trial of OTX-DP for allergic conjunctivitis, the Company’s plans for
regulatory submissions and the advancement of the Company's other
product candidates, the potential for the Company’s sustained release
hydrogel depot technology 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 submissions and 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 quarterly and annual reports on file with the
View source version on businesswire.com: http://www.businesswire.com/news/home/20151022006612/en/
Source:
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
Ocular
Therapeutix, Inc.
Scott Corning
Vice President of Sales and
Marketing
scorning@ocutx.com