Ocular Therapeutix Announces Additional Successful Results for Phase 3 Clinical Trial of Dextenza

Source: Ocular Therapeutix

Wednesday, January 04, 2017 | Cataract Surgery , Clinical Trials , Ocular Therapeutix


Ocular Therapeutix announced additional positive secondary endpoint results from its most recent successful phase 3 clinical trial of Dextenza (dexamethasone insert) 0.4 mg for the treatment of postsurgical ocular inflammation and pain. Dextenza is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed to release drug to the ocular surface for up to 30 days.

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,” Jonathan H. Talamo, MD, Chief Medical Officer of Ocular Therapeutix, said in a company news release. “Ocular flare occurs when the protein content of the aqueous humor increases due to intraocular inflammation, so the fact that we are seeing a statistically significant decrease in the absence of flare across all time points further supports the efficacy profile of Dextenza.”

Summary of Efficacy Results from Third Phase 3 Trial of DEXTENZA for the Treatment of Postsurgical 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
(P Value)

  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
(P Value)

  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
(P Value)

  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 the United States. Immediately following surgery, patients were randomized to insertion of either Dextenza or a placebo vehicle. Primary efficacy endpoints evaluated the differences between the Dextenza treatment group and the placebo group for the absence of anterior chamber cells at day 14 and absence of pain at day 8. Secondary efficacy endpoints included absence of anterior chamber cells, absence of ocular flare, and absence of ocular pain across relevant time points during the 30-day treatment period.

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, Ocular Therapeutix plans to resubmit a New Drug Application (NDA) to the FDA for Dextenza for the treatment of ocular pain occurring after ophthalmic surgery early in the first quarter of 2017. The purpose of conducting this third Phase 3 clinical trial was to support the Company’s label expansion strategy for Dextenza. Accordingly, subject to the approval of the NDA for post-surgical ocular pain by the FDA, Ocular Therapeutix intends to submit a supplemental NDA for Dextenza to broaden its label to include an indication for post-surgical inflammation.


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