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|Ocular Therapeutix™ Begins Enrollment in First Phase 3 Clinical Trial with OTX-TP (Sustained Release Travoprost) for the Treatment of Glaucoma and Ocular Hypertension|
Phase 3 study design to compare OTX-TP with placebo inserts; no timolol validation arm required
Refined product design shows significant improvement in patient retention over 3-month duration
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 (IOP) from baseline with OTX-TP compared to placebo at 2, 6 and 12 weeks following insertion.
“This is the first Phase 3 clinical trial to be conducted with a
non-invasive, sustained release drug candidate for the treatment of
glaucoma and represents an important advancement in the field of
“This is the first of two planned Phase 3 clinical trials that will both
include an OTX-TP treatment arm and a placebo-controlled comparator arm
using a non-drug eluting hydrogel-based intracanalicular insert,” said
Dr. Sawhney continued, “We are also pleased with the results of the refined OTX-TP product configuration we will be using in these studies. Our most recent results from ongoing non-significant risk (NSR) investigational device exemption (IDE) human clinical studies using the non-drug eluting version of the insert show significant improvements in retention rates at three months compared to previous studies.”
About Glaucoma and Ocular Hypertension
Glaucoma is a chronic, sight-threatening disease in which abnormally
high intraocular pressure may cause damage to the optic nerve, resulting
in irreversible vision loss. Glaucoma is the second leading cause of
blindness in the world. Ocular hypertension is characterized by higher
levels of intraocular pressure without detectable 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.
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 is designed to deliver the prostaglandin analog travoprost to the ocular surface for up to 90 days. OTX-TP 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. If approved, OTX-TP may become the first non-invasive, sustained release therapy for the treatment of glaucoma.
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DEXTENZA™ for post-surgical ocular inflammation and pain, including our
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