$OCUL dissapointing phase III data stock is down 4
Post# of 23076
Posted On: 06/06/2016 9:52:32 AM
$OCUL dissapointing phase III data stock is down 41% on watch
Ocular Therapeutix Inc. said Monday that a late-stage clinical trial for an anti-eye-itching medication failed to achieve its goals.
Shares fell 41% in premarket trading.
The drug, Dextenza, was in a Phase III clinical trial to treat allergy-associated eye itching. The company said the drug didn't reduce eye itching by a statistically significant amount in its randomized study of 86 patients.
This trial was being watched by outside observers for the medicine as much as for the treatment method. Instead of using typical eye drops or injections, the drug is inserted into the eye via an intracanalicular depot, which releases medicine for up to 30 days, after which the depot is absorbed into the body.
The drug and its treatment method exhibited a strong safety profile and was generally well-tolerated, the company said. No serious adverse health events were observed in the trial.
A previous Phase III trial testing the same goals was successful, the company said in October.
Monday, Ocular Therapeutix said it was analyzing data from the two trials to understand why the outcomes were different.
"We are disappointed that the primary endpoint of ocular itching associated with allergic conjunctivitis was not achieved in our second Phase 3 trial in these patients," said Chief Executive Amar Sawhney . "We are currently in the process of conducting a thorough analysis of the data from the second Phase 3 trial to fully understand the difference in efficacy between the two Phase 3 trials.
The drug also is being tested for the treatment of inflammatory dry-eye disease and post-surgery eye pain and inflammation.
Write to Austen Hufford at austen.hufford@wsj.com
(END) Dow Jones Newswires
06-06-16 0858ET
Copyright (c) 2016 Dow Jones & Company, Inc.
Ocular Therapeutix Inc. said Monday that a late-stage clinical trial for an anti-eye-itching medication failed to achieve its goals.
Shares fell 41% in premarket trading.
The drug, Dextenza, was in a Phase III clinical trial to treat allergy-associated eye itching. The company said the drug didn't reduce eye itching by a statistically significant amount in its randomized study of 86 patients.
This trial was being watched by outside observers for the medicine as much as for the treatment method. Instead of using typical eye drops or injections, the drug is inserted into the eye via an intracanalicular depot, which releases medicine for up to 30 days, after which the depot is absorbed into the body.
The drug and its treatment method exhibited a strong safety profile and was generally well-tolerated, the company said. No serious adverse health events were observed in the trial.
A previous Phase III trial testing the same goals was successful, the company said in October.
Monday, Ocular Therapeutix said it was analyzing data from the two trials to understand why the outcomes were different.
"We are disappointed that the primary endpoint of ocular itching associated with allergic conjunctivitis was not achieved in our second Phase 3 trial in these patients," said Chief Executive Amar Sawhney . "We are currently in the process of conducting a thorough analysis of the data from the second Phase 3 trial to fully understand the difference in efficacy between the two Phase 3 trials.
The drug also is being tested for the treatment of inflammatory dry-eye disease and post-surgery eye pain and inflammation.
Write to Austen Hufford at austen.hufford@wsj.com
(END) Dow Jones Newswires
06-06-16 0858ET
Copyright (c) 2016 Dow Jones & Company, Inc.
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