Ocular Therapeutix Inc. (NASDAQ: OCUL) shares plunged early on Monday following less-than-favorable results, although the news was not all bad. The company announced top-line results from its second Phase 3 clinical trial to evaluate the safety and efficacy of Dextenza (sustained-release dexamethasone) intracanalicular depot for the treatment of ocular itching associated with chronic allergic conjunctivitis.
Dextenza is a product candidate administered by a physician as a bioresorbable intracanalicular depot and designed for drug release to the ocular surface for up to 30 days. The single primary endpoint of the trial was defined as the difference in the mean scores in ocular itching between the treatment group and the placebo comparator group. Unfortunately, this difference did not reach statistical significance.
In the other facets of the Phase 3 trials, Dextenza was successful and well-tolerated, with no servious adverse events observed.
Looking ahead, Dextenza has a PDUFA date set for July 2016.
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Amar Sawhney, Ph.D., president, CEO and chairman, commented:
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. We are currently in the process of conducting a thorough analysis of the data from the second Phase 3 trial to fully understand the difference in efficacy between the two Phase 3 trials. There was a greater variability in ocular itching exhibited by patients in the second Phase 3 trial over the multiple allergen challenges 7, 14 and 28 days following insertion of the depots, compared to the first Phase 3 trial. In a post hoc analysis, when ocular itching scores were averaged over these multiple visits, a statistically significant reduction of symptoms over the entire 1 month intended duration of sustained release, single dose therapy was observed in the DEXTENZA treatment group relative to the placebo vehicle group. Since this analysis was not part of the original end points, we plan to meet with the FDA to discuss the results and chart an appropriate path forward for the development of DEXTENZA for the treatment of allergic conjunctivitis.
Shares of Ocular were down about 28% at $8.50 in early trading indications on Monday. The stock has a consensus analyst price target of $38.75 and a 52-week trading range of $5.07 to $29.22.
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