Ocular Therapeutix, Inc. OCUL crumbled almost 19% after announcing disappointing results from its second phase III study on its pipeline candidate OTX-DP. The study is evaluating the safety and efficacy of its lead candidate, OTX-DP, for the treatment of ocular inflammation and pain following cataract surgery.
The company said that OTX-DP has failed to meet one of the two primary efficacy endpoints. The candidate needed to meet both the primary endpoints to be successful in the second phase III study.
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.
The candidate is also being developed for other indications. Ocular Therapeutix intends to start phase III studies on OTX-DP in allergic conjunctivitis in mid-2015. Last year, the company reported positive results from a phase II study on OTX-DP in the allergic conjunctivitis indication. Also, OTX-DP is being developed in a phase II study for inflammatory dry eye indication.
Ocular Therapeutix carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care space include Acorda Therapeutics, Inc. ACOR, Cytokinetics, Incorporated CYTK and Affymetrix Inc. AFFX. All stocks hold a Zacks Rank #1 (Strong Buy).
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