OTX DP (SR dexamethasone) meets endpoint in second Phase III trial for ocular inflammation-Ocular Therapeutix

Ocular Therapeutix has announced topline data from the second of two Phase III clinical trials evaluating the safety and efficacy of its lead product candidate, OTX DP (sustained release dexamethasone, 0.4mg), for the treatment of ocular inflammation and pain following cataract surgery and reported additional details from the first Phase III trial.

The two primary efficacy endpoints for the OTX-DP trials were statistically significant differences between the treatment group and the placebo group for the absence of pain on day 8 and absence of inflammatory cells on day 14. Both endpoints need to be met for the trials to be considered successful. In the second Phase III clinical trial, OTX-DP met one of the study’s two primary efficacy endpoints. In this trial, 77.5% of patients receiving OTX-DP reported an absence of pain in the study eye on day 8 following insertion of the drug product, compared to 58.8% of those receiving placebo vehicle control punctum plug, a difference which was statistically significant (p=0.0025).

39.4% of OTX-DP-treated patients showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14 following drug product insertion, compared to 31.3% of those receiving placebo vehicle control punctum plug , a difference which was not statistically significant (p=0.2182). Additionally, there were a total of 240 patients enrolled in the second clinical trial, with a 2:1 randomization of treated and control patients.