Ocular Therapeutix™ Announces Topline Results of Second Phase 3 Clinical Trial of DEXTENZA™ for the Treatment of Allergic Conjunctivitis
Primary endpoint for ocular itching not achieved
Conference call today at
The single primary endpoint of the trial, defined as the difference in the mean scores in ocular itching between the treatment group and the placebo comparator group at three time points 7 days following insertion of the depots, was not achieved. While mean ocular itching was seen to be numerically lower (more favorable) in the DEXTENZA treatment group compared to the placebo group measured 7 days following insertion of the depots, at 3, 5, and 7 minutes by -0.18, -0.29, and -0.29 units, respectively, on a five point scale, this difference did not reach statistical significance. In addition, the trial did not achieve the requirement of at least a 0.5 unit difference at all three time points 7 days following insertion of the depots and at least a 1.0 unit difference at the majority of the three time points between the treatment group and the placebo group 7 days following insertion of the depots.
The trial also assessed conjunctival redness as a secondary endpoint. The differences in the mean scores in conjunctival redness between the DEXTENZA treatment group and the placebo group 7 days following insertion of the depots at 7, 15 and 20 minutes were -0.35, -0.39 and -0.42, respectively, compared with values of -0.26, -0.32 and -0.41, respectively, at the same time points 7 days following insertion of the depots in the first Phase 3 trial.
The results from the second Phase 3 trial contrast with those achieved
in the first Phase 3 clinical trial of DEXTENZA for the treatment of
allergic conjunctivitis announced in
In the second Phase 3 clinical trial, as well as other DEXTENZA clinical trials completed to date regardless of indication, DEXTENZA has exhibited a strong safety profile and has been generally well-tolerated. There were no serious adverse events observed in the second Phase 3 clinical trial.
“We are disappointed that the primary endpoint of ocular itching
associated with allergic conjunctivitis was not achieved in our second
Phase 3 trial in these patients, and this result is inconsistent with
what we saw in our first Phase 3 trial,” said
Dr. Sawhney continued, “We remain confident in the potential of our
innovative sustained release platform to address diverse applications in
ophthalmology. We look forward to the
Second Phase 3 Study Design
This Phase 3 prospective, U.S.-based multicenter, 1:1 randomized,
double-masked, vehicle-controlled trial in 86 patients was designed to
evaluate the safety and efficacy of DEXTENZA™ (sustained release
dexamethasone), Intracanalicular Depot for the treatment of signs and
symptoms of chronic allergic conjunctivitis. This was the second Phase 3
trial which evaluated DEXTENZA versus a placebo vehicle punctum plug
using Ophthalmic Research Associate’s modified Conjunctival Allergen
Challenge (Ora-CAC®) Model (
The trial was designed to assess the effect of DEXTENZA compared with placebo on allergic reactions. DEXTENZA or placebo was administered 48 to 72 hours after the first set of allergen challenges confirming the appropriate allergen and dose exposure to incite an allergic response, followed by three series of successive allergen challenges over a 30 day period. The primary efficacy endpoint evaluated was the difference in mean scores in ocular itching between the treatment group and the placebo vehicle group at three time points 7 days following insertion of the depots. The trial also included a secondary efficacy endpoint for conjunctival redness which evaluated the difference in mean scores in conjunctival redness between the treatment group and the placebo vehicle group at three time points 7 days following insertion of the depots.
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 symptom of this inflammation is
acute ocular itching and the primary sign is conjunctival redness.
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 (Ora-CAC®) Model
The modified Ora-CAC® model used in the recently completed clinical trial 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
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Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about 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 allergic conjunctivitis, DEXTENZA for
post-surgical ocular inflammation and pain, including our expectations
regarding the pending PDUFA date for the NDA filed with the
Ocular Therapeutix, Inc.
Chief Financial Officer
Burns McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
Ocular Therapeutix, Inc.
Vice President of Sales and Marketing