Press Release
Ocular TherapeutixTM Completes End-of-Phase 2 Review with FDA for OTX-TP (Sustained Release Travoprost) for Glaucoma and Ocular Hypertension
First Phase 3 trial expected to commence in the third quarter of 2016
Trial design to evaluate OTX-TP using placebo as comparator; no timolol validation arm required
Based on this review, the company intends to initiate the first of two
Phase 3 clinical trials during the third quarter of 2016. The
- Two Phase 3 clinical trials that will include an OTX-TP treatment arm and a placebo-controlled comparator arm that would use a non-drug eluting hydrogel-based intracanalicular depot.
- The Phase 3 study design will not include a timolol comparator or validation arm.
- The study design will not have eye drops, placebo or active, administered in either arm.
-
A primary efficacy endpoint of statistically superior and clinically
meaningful reduction of intraocular pressure (IOP) from baseline with
OTX-TP compared to placebo at 60 and 90 days. The
FDA has also indicated that they will take into consideration the risk-reward profile of OTX-TP relative to currently available therapies in their evaluation of the Phase 3 clinical trial results.
“We are pleased with the End-of-Phase 2 feedback from
About Glaucoma and Ocular Hypertension
Glaucoma is a
chronic, sight-threatening diseases in which elevated levels of
intraocular pressure are associated with damage to the optic nerve,
which may result in irreversible vision loss. Glaucoma is the second
leading cause of blindness in the world. Ocular hypertension is
characterized by elevated levels of intraocular pressure without any
optic nerve damage. Patients with ocular hypertension are at high risk
of developing glaucoma. In the U.S. alone 2.7 million people suffer from
glaucoma. According to
Compliance is seen as the biggest problem with existing therapies for glaucoma, and more than 50% of patients on topical prostaglandin analogs are not compliant with their therapy within the first six months of treatment.
About OTX-TP (Sustained Release Travoprost)
OTX-TP
(sustained release travoprost) is a preservative-free drug product
candidate that resides within the canaliculus and delivers the
prostaglandin analog travoprost to the ocular surface for up to 90 days.
The drug depot is designed to deliver a continuous steady release
throughout the treatment period. A fluorescent visualization aid is
formulated within the product to enable both the physician and the
patient to monitor drug presence throughout the course of therapy.
About
Forward Looking Statements
Any statements in this press
release about future expectations, plans and prospects for the Company,
including statements about the development and regulatory status of the
Company’s product candidates, such as the ongoing development of OTX-TP
for glaucoma and ocular hypertension and the timing, design and conduct
of the planned Phase 3 clinical trials of OTX-TP, the availability of
data from clinical trials, the Company’s plans for regulatory
submissions, the potential utility of any of the Company’s product
candidates, the ongoing development of the Company’s sustained release
hydrogel depot technology and the advancement of the Company’s other
product candidates, the sufficiency of the Company’s cash resources and
other statements containing the words "anticipate," "believe,"
"estimate," "expect," "intend", "goal," "may", "might," "plan,"
"predict," "project," "target," "potential," "will," "would," "could,"
"should," "continue," and similar expressions, constitute
forward-looking statements within the meaning of
View source version on businesswire.com: http://www.businesswire.com/news/home/20160427006688/en/
Source:
Investors
Ocular Therapeutix, Inc.
Brad Smith
Chief
Financial Officer
bsmith@ocutx.com
or
Burns
McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
sklass@burnsmc.com
or
Media
Ocular
Therapeutix, Inc.
Scott Corning
Vice President of Sales and
Marketing
scorning@ocutx.com