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Second phase 3 trial of OTX-DP meets one of two primary endpoints
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The second phase 3 trial of OTX-DP did not meet the primary endpoint of absence of inflammatory cells but met the primary endpoint of absence of pain, according to topline data released by Ocular Therapeutix.
The trial included 240 patients who were randomized to treatment with OTX-DP (sustained-release dexamethasone 0.4 mg) or a placebo vehicle control punctum plug.
On day 8 after insertion of the product, 77.5% of patients treated with OTX-DP reported absence of pain in the study eye compared with 58.8% of patients in the placebo group. The difference was statistically significant (P = .0025).
On day 14 after insertion of the product, 39.4% of patients treated with OTX-DP showed an absence of inflammatory cells in the anterior chamber of the study eye compared with 31.3% of patients in the placebo group. The difference was not statistically significant.
“Following the favorable results from our first phase 3 trial, we are disappointed that the second phase 3 clinical results for the resolution of inflammation did not have the same magnitude of differential as what OTX-DP achieved in the first trial,” Amar Sawhney, PhD, president and CEO of Ocular Therapeutix, said in the release. “We plan to meet with the FDA promptly to discuss the phase 3 clinical trial results and chart the appropriate path forward.”
No ocular or treatment-related serious adverse events were reported in the OTX-DP group in either of the two phase 3 trials.