BEDFORD, MA, USA I November 12, 2014 I Ocular Therapeutix, Inc. (OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, announced today enrollment of the first patients in a Phase 2b clinical trial evaluating Sustained Release Travoprost (OTX-TP) for the reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension. OTX-TP is administered by a physician as an insert into the punctum, a natural opening in the eyelid near the tear ducts, designed to deliver travoprost to the ocular surface for up to 90 days.
The prospective, multicenter, randomized, double-masked, parallel-arm, active controlled study is designed to evaluate 80 patients at 10 clinical sites for the safety and efficacy of the OTX-TP as compared to timolol. Study efficacy endpoints include difference in the mean intraocular pressure change between the treatment groups from baseline at multiple timepoints throughout the study.
Previous pilot and Phase 2a clinical trials evaluating OTX-TP showed robustreductions in intraocular pressure for up to three months, similar to results found with twice-daily timolol dosing. No serious adverse events occurred, including no increases in hyperemia, and patients were comfortable with use of the plug overall. “It is our hope that OTX-TP will have a significant impact in helping to fight one of the leading causes of blindness in the world,” stated Amar Sawhney, Ph.D., President and CEO of Ocular Therapeutix, Inc.
Glaucoma and ocular hypertension are chronic, sight-threatening diseases caused by elevated intraocular pressure, which affects approximately 2.7 million people in the United States alone, which resulted in 31 million prescriptions and sales over $2.1 billion in 2013.1,2 Many of those afflicted with the disease have difficulty complying with the required dosing regimen or being able to self-administer eye drops, which is especially troublesome as patients get older. “Many patients do not adhere to dosing regimens, which can quickly lead to vision problems. Sustained release glaucoma therapy helps eliminate the burden placed on patients for daily administration of eye drops,” stated Steven D. Vold, M.D., Founder and CEO of Vold Vision in Fayetteville, Arkansas, a Principal Investigator on the trial.
About Sustained Release Travoprost
Sustained Release Travoprost (OTX-TP) is a preservative-free drug product candidate that resides within the canaliculus and delivers the prostaglandin analog (travoprost) to the ocular surface for approximately 90 days. The drug release is tailored such that a continuous, low-dose is sustained throughout the treatment period. A visualization aid is incorporated into the plug so that both the doctor and the patient may monitor drug presence through the entire course of therapy.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology. Ocular Therapeutix’s lead product candidates are in Phase 3 clinical development for post-surgical ocular inflammation and pain, and Phase 2 clinical development for glaucoma and allergic conjunctivitis. The Company is also evaluating sustained-release injectable anti-VEGF drug depots for back-of-the-eye diseases. Ocular Therapeutix’s first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery. For more information, please visit www.ocutx.com.
SOURCE: Ocular Therapeutix
Post Views: 87
BEDFORD, MA, USA I November 12, 2014 I Ocular Therapeutix, Inc. (OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, announced today enrollment of the first patients in a Phase 2b clinical trial evaluating Sustained Release Travoprost (OTX-TP) for the reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension. OTX-TP is administered by a physician as an insert into the punctum, a natural opening in the eyelid near the tear ducts, designed to deliver travoprost to the ocular surface for up to 90 days.
The prospective, multicenter, randomized, double-masked, parallel-arm, active controlled study is designed to evaluate 80 patients at 10 clinical sites for the safety and efficacy of the OTX-TP as compared to timolol. Study efficacy endpoints include difference in the mean intraocular pressure change between the treatment groups from baseline at multiple timepoints throughout the study.
Previous pilot and Phase 2a clinical trials evaluating OTX-TP showed robustreductions in intraocular pressure for up to three months, similar to results found with twice-daily timolol dosing. No serious adverse events occurred, including no increases in hyperemia, and patients were comfortable with use of the plug overall. “It is our hope that OTX-TP will have a significant impact in helping to fight one of the leading causes of blindness in the world,” stated Amar Sawhney, Ph.D., President and CEO of Ocular Therapeutix, Inc.
Glaucoma and ocular hypertension are chronic, sight-threatening diseases caused by elevated intraocular pressure, which affects approximately 2.7 million people in the United States alone, which resulted in 31 million prescriptions and sales over $2.1 billion in 2013.1,2 Many of those afflicted with the disease have difficulty complying with the required dosing regimen or being able to self-administer eye drops, which is especially troublesome as patients get older. “Many patients do not adhere to dosing regimens, which can quickly lead to vision problems. Sustained release glaucoma therapy helps eliminate the burden placed on patients for daily administration of eye drops,” stated Steven D. Vold, M.D., Founder and CEO of Vold Vision in Fayetteville, Arkansas, a Principal Investigator on the trial.
About Sustained Release Travoprost
Sustained Release Travoprost (OTX-TP) is a preservative-free drug product candidate that resides within the canaliculus and delivers the prostaglandin analog (travoprost) to the ocular surface for approximately 90 days. The drug release is tailored such that a continuous, low-dose is sustained throughout the treatment period. A visualization aid is incorporated into the plug so that both the doctor and the patient may monitor drug presence through the entire course of therapy.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology. Ocular Therapeutix’s lead product candidates are in Phase 3 clinical development for post-surgical ocular inflammation and pain, and Phase 2 clinical development for glaucoma and allergic conjunctivitis. The Company is also evaluating sustained-release injectable anti-VEGF drug depots for back-of-the-eye diseases. Ocular Therapeutix’s first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery. For more information, please visit www.ocutx.com.
SOURCE: Ocular Therapeutix
Post Views: 87
