April 7, 2015
By Alex Keown, BioSpace.com Breaking News Staff
BEDFORD, Mass. — One of two late-stage Phase III clinical trials for Ocular Therapeutix, Inc. ’s post-operative cataract drug therapy OTX-DP failed to meet desired endpoints in treating inflammation, which sent the company’s stock tumbling this morning.
Stocks tumbled 30 percent after Ocular released its report this morning. Shares fell from Monday’s high of $40.95 to $26.70 in early trading today. Ocular Therapeutix went public in July with an initial public offering that priced at $13 per share. The stock had nearly tripled in value since then.
OTX-DP is a hydrogel drug implanted in a patient’s tear duct that is designed to deliver dexamethasone to the ocular surface for approximately four weeks. Following treatment, OTX-DP resorbs and exits the body without need for physician-assisted removal. The late-stage clinical trial of 240 patients showed that patients who received the medication showed a significant absence of pain after several days in comparison to a group that received a placebo treatment; however, there was no statistically significant difference in the reduction of inflammation between patients who received the mediation versus the placebo. The trial did meet its expected endpoints regarding safety of the medication.
The company said it was disappointed in the results of the Phase III trial, especially after earlier trials showed such promise. Company officials said they are conducting a review of the data from the trial results in order to better understand the results. In a press release Amar Sawhney, chief executive officer for Ocular Therapeutix, said the company will meet with federal regulators from the U.S. Food and Drug Administration (FDA) to discuss the results of the clinical trials and map out the next steps. The company had planned to submit a marketing application for the drug later this year.
Based in Bedford, Mass., Ocular Therapeutix employs about 75 people. The company announced last month it expected to expand its sales force following regulatory approval of OTX-DP, but that will certainly be deferred following the late-stage clinical trial results.
Last month results from another late-stage trial featuring 247 patients were released, that showed OTX-DP met its end goals in relieving pain and inflammation in patients following cataract procedures.
In addition to post-operative cataracts treatment, OTX-DP is also being investigated for treatments for glaucoma, allergic conjunctivitis and inflammatory dry eye.
In January of 2014 the FDA approved Ocular‘s first product, ReSure Sealant, which is used to prevent postoperative fluid loss from the eye following cataract surgery. When announcing fourth quarter financial results last month, the company said it expects limited sales of ReSure this year.
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