Shows slights progress on the second endpoint but not so significant. Not quite out yet plus other promising pipe line candidates:)
Results revealed that 39.4% of patients treated with OTX-DP showed an absence of inflammatory cells as compared to 31.3% of patients under placebo vehicle control punctum plug. The difference was not statistically significant.
However, the study was successful in meeting the other primary endpoint of a statistically significant number of patients under OTX-DP achieving absence of pain as compared to those under placebo. Moreover, the candidate was successful in the first phase III study where it met both the primary efficacy endpoints of reduction of inflammatory cells and pain.
The company now plans to meet with the FDA in order to discuss the results from the two phase III studies on OTX-DP.