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
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.
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development of the Company’s product candidates, such as the ongoing
development and potential utility of OTX-DP for allergic conjunctivitis
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Ocular Therapeutix, Inc.
Chief Financial Officer
Burns McClellan on behalf of Ocular Therapeutix
Kimberly Minarovich, 212-213-0006
Ocular Therapeutix, Inc.
Vice President of Sales and Marketing