Ocular Therapeutix Eye-Pain Implant Fails Crucial Clinical Study

Ocular Therapeutix, a biopharmaceutical company working on therapies for eye diseases, experienced a setback Monday when its implant was unable to reduce swelling compared to a dummy device in a second phase 3 study reports The Street’s Adam Feuerstein.

Ocular’s implantable device, known as OTX-DP, is inserted into the tear duct to directly administer steroids to patients recovering from cataract surgery over the course of four weeks.

In February 2014, Ocular conducted the first phase 3 examination of OTX-DP with a randomized group of 247 patients to evaluate the safety and efficacy profile of the product.

Another article from The Street breaks down the results from this examination:

• 34 percent of patients demonstrated an absence of inflammation after 14 days, while 15 percent who received treatment in the control group did not.
• 76 percent said they felt a lack of pain within 8 days, compared to 36 percent of the control group.

These statistics caused the company to pursue a second trial. However, Ocular released a statement saying it was disappointed in the results hampering the company’s attempts at getting approval in the U.S.

President and CEO Amar Sawhney added: “Although the efficacy results for the absence of inflammatory cells in the OTX-DP treatment group met our expectations, the placebo group response was significantly higher than expected. We have begun a thorough analysis of the data from the second Phase 3 trial to fully understand the difference in efficacy between these two trials that had essentially the same trial design and similar patient populations.”

Sawhney continued saying he would meet with regulators from the Food and Drug Administration to figure out how to proceed.

Investors didn’t seem pleased about this either. Shares fell 30 percent in after-hours trading on Monday, according to Business Insider.