Ocular Therapeutix Inc’s Drug OTX-DP fails in Second Phase-III Clinical Trial

Ocular Therapeutix announced that its leading eye drug failed to meet one of the main goals in a second late-stage study.

The leading developer of ophthalmic therapies said that its drug, OTX-DP, is a hydrogel formulation which is effective in reducing pain in patients who had cataract surgery. But the drug failed to reduce the inflammation in the eyes, the company said.

The investigators in the first Phase III noted that while the drug performed better than a dummy version in reducing pain, it failed to distinguish itself from the placebo.

The company affirmed that the drug has to meet both the endpoints for the trail to be considered successful.

It further said it is now looking forward to meet the US Food and Drug Administration to discuss the trial results.

The company presently is also busy testing the drug for treating inflammation related to dry eye. A mid-stage trial was started in January.

As per experts, Ocular Therapeutix needs a clean sweep in its expansive Phase III program for a postoperative eye treatment in order to set itself for a clear shot at an FDA approval.

CEO Amar Sawhney straightaway blamed the failure of the drug on a high placebo response, but it is still unclear how persuasive the drug may be with regulators if the treatment gets to the market.

Any new therapy competing against cheap and long-established competitors would have to clearly distinguish itself in order to carve out significant market share, said experts.

Sawhney said, "Following the favorable results from our first Phase III trial, we are disappointed that the second Phase III clinical results for resolution of inflammation did not have the same magnitude of differential as what OTX- DP achieved in the first trial".