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OCUL

Ocular Therapeutix

$6.96

0.11 (1.61%)

16:06
10/04/16
10/04
16:06
10/04/16
16:06

Ocular Therapeutix starts enrollment in Phase 3 clinical trial with OTX-TP

Ocular Therapeutix announced the enrollment of the first patient in the first of two planned Phase 3 clinical trials with OTX-TP for the treatment of glaucoma and ocular hypertension. OTX-TP is a preservative-free drug product candidate that resides within the canaliculus and is designed to deliver the prostaglandin analog travoprost to the ocular surface for up to 90 days. The U.S.-based, prospective, multicenter, randomized, parallel-arm, placebo-controlled study is expected to enroll approximately 550 patients with open angle glaucoma or ocular hypertension at 50 clinical sites. Importantly, the Phase 3 study design will not include a timolol comparator or validation arm, and will not have active or placebo eye drops administered in either arm. The comparator arm will utilize a non-drug eluting hydrogel-based intracanalicular insert. The primary efficacy endpoint will be statistically superior reduction of intraocular pressure from baseline with OTX-TP compared to placebo at 2, 6 and 12 weeks following insertion.

OCUL Ocular Therapeutix
$6.96

0.11 (1.61%)

06/06/16
COWN
06/06/16
NO CHANGE
Target $60
COWN
Outperform
Ocular OTX-DP data miss 'meaningless' to Outperform thesis, says Cowen
Cowen said that while any clinical trial failure of any kind is always a disappointment, the OTX-DP miss in allergic conjunctivitis reported by Ocular Therapeutix is "meaningless" to the firm's thesis, which is predicated "nearly entirely" on the OTX-TP opportunity for the treatment of glaucoma. The firm keeps an Outperform rating and $60 price target on Ocular shares.
06/07/16
MSCO
06/07/16
NO CHANGE
Target $16
MSCO
Overweight
Ocular Therapeutix weakness an overreaction, says Morgan Stanley
Morgan Stanley analyst Andrew Berens said the initial investor reaction to the failure of the second Phase III trial for Dextenza in allergic conjunctivitis appears extreme. Berens said he assigned little direct value for the allergy opportunity and does not see a read through to the post-op indication. The analyst said the focus remains on Dextenza's July 24 PDUFA in post surgical pain and maintains his Overweight rating on Ocular and $16 price target.
07/26/16
RBCM
07/26/16
NO CHANGE
RBCM
Ocular Therapeutix risk/reward still positive, says RBC Capital
After the FDA issued a complete response letter for Ocular's Dextenza, RBC Capital analyst Adnan Butt notes that the agency did not ask for more safety or efficacy data about the drug. According to the analyst, the company has already issued a response to the letter, and the FDA's reply could come in one to three months. Butt thinks that the stock could still advance if Dextenza and a number of its other drugs are approved. The analyst trimmed the price target on the shares to $38 from $40 but keeps an Outperform rating on the stock.
08/11/16
JMPS
08/11/16
INITIATION
Target $21
JMPS
Outperform
Ocular Therapeutix initiated with an Outperform at JMP Securities
Target $21.

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