Expands Clinical Program of Hydrogel Platform Technology into New Indication
BEDFORD, MA, USA I January 21, 2015 I Ocular Therapeutix™, Inc. (NASDAQ: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 patient in a Phase 2 clinical trial to evaluate the safety and efficacy of Sustained Release Dexamethasone (OTX-DP), an ophthalmic corticosteroid for the treatment of inflammatory dry eye disease. Ocular Therapeutix’s dexamethasone is being developed for administration as a one-time, bioresorbable intracanalicular plug for drug release to the ocular surface for up 30 days.
In this prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled study, 40 patients (up to 80 eyes) exhibiting signs and symptoms of dry eye disease are expected to be enrolled at two sites in the United States. Designed as a serial phase study, patients will initially be administered a placebo vehicle plug for 30 days to establish a baseline for the investigational drug treatment. Patients who respond to the placebo plug only in treatment of their dry eye disease will be excluded from the study. Patients who continue to exhibit symptoms of dry eye during the initial 30 days will be qualified for enrollment in the treatment phase of the study. Qualified patients will then be randomized to either OTX-DP or a placebo vehicle plug. Primary efficacy measures will include corneal and conjunctival staining, tear osmolarity, tear film break-up time, presence of the plug, ease of product use and visualization, and resorption of the plug following therapy.
“This Phase 2 exploratory study is designed to assist us in identifying the subgroup of patients that may benefit from a low-dose, Sustained Release Dexamethasone therapy for treatment of inflammatory dry eye disease, allowing us to refine clinical trials for this indication in the future,” stated Amar Sawhney, Ph.D., President and CEO of Ocular Therapeutix, Inc. “Dry eye is one of the most common ophthalmic disorders affecting approximately 20 million people in the United States, and is expected to rise with an aging population. We look forward to potentially expanding the use of our Sustained Release Dexamethasone product candidate for this disorder.”
“Ocular Therapeutix’s Sustained Release Dexamethasone may offer more consistent therapeutic medication levels than traditional treatments for patients who suffer from dry eye disease, and, if successful, may reduce the burden and potential toxicity of continuous repeated drop applications,” stated John Sheppard, M.D., of Virginia Eye Consultants in Norfolk, VA, and a Principal Investigator in the study.
About Dry Eye
Dry eye disease affects the ocular surface and is characterized by dryness, inflammation, pain, discomfort, and irritation. Dry eye is a complex, multifactorial disease which can present differently in patients, and becomes more common with age. Due to the prevalence of the disease, over one billion dollars is spent on treatment of the disease each year in the United States alone (IMS Health, 2013). One cause of the disease is inflammation of the ocular surface resulting from a patient’s immune response. Although physicians may prescribe topical steroid eye drops for the treatment of dry eye disease, chronic use of topical steroids can lead to elevations in intraocular pressure, which is a risk factor for glaucoma. Conversely, patients often do not reliably self-administer these drops, which can lead to eye irritation and continual, if not more, inflammation.
About Ocular Therapeutix’s Intracanalicular Plugs:
Ocular Therapeutix is developing the company’s proprietary absorbable polyethylene glycol hydrogel intracanalicular plug technology to release drugs in a sustained fashion over a specified period of time depending on the drug and its corresponding therapeutic need. At the end of the treatment period, the plug is designed to absorb, and exit the nasolacrimal system without need for removal by the physician. The plugs contain a visualization agent for retention monitoring throughout the treatment period.
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, allergic conjunctivitis, and dry eye disease. 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.
SOURCE: Ocular Therapeutix
Post Views: 110
Expands Clinical Program of Hydrogel Platform Technology into New Indication
BEDFORD, MA, USA I January 21, 2015 I Ocular Therapeutix™, Inc. (NASDAQ: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 patient in a Phase 2 clinical trial to evaluate the safety and efficacy of Sustained Release Dexamethasone (OTX-DP), an ophthalmic corticosteroid for the treatment of inflammatory dry eye disease. Ocular Therapeutix’s dexamethasone is being developed for administration as a one-time, bioresorbable intracanalicular plug for drug release to the ocular surface for up 30 days.
In this prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled study, 40 patients (up to 80 eyes) exhibiting signs and symptoms of dry eye disease are expected to be enrolled at two sites in the United States. Designed as a serial phase study, patients will initially be administered a placebo vehicle plug for 30 days to establish a baseline for the investigational drug treatment. Patients who respond to the placebo plug only in treatment of their dry eye disease will be excluded from the study. Patients who continue to exhibit symptoms of dry eye during the initial 30 days will be qualified for enrollment in the treatment phase of the study. Qualified patients will then be randomized to either OTX-DP or a placebo vehicle plug. Primary efficacy measures will include corneal and conjunctival staining, tear osmolarity, tear film break-up time, presence of the plug, ease of product use and visualization, and resorption of the plug following therapy.
“This Phase 2 exploratory study is designed to assist us in identifying the subgroup of patients that may benefit from a low-dose, Sustained Release Dexamethasone therapy for treatment of inflammatory dry eye disease, allowing us to refine clinical trials for this indication in the future,” stated Amar Sawhney, Ph.D., President and CEO of Ocular Therapeutix, Inc. “Dry eye is one of the most common ophthalmic disorders affecting approximately 20 million people in the United States, and is expected to rise with an aging population. We look forward to potentially expanding the use of our Sustained Release Dexamethasone product candidate for this disorder.”
“Ocular Therapeutix’s Sustained Release Dexamethasone may offer more consistent therapeutic medication levels than traditional treatments for patients who suffer from dry eye disease, and, if successful, may reduce the burden and potential toxicity of continuous repeated drop applications,” stated John Sheppard, M.D., of Virginia Eye Consultants in Norfolk, VA, and a Principal Investigator in the study.
About Dry Eye
Dry eye disease affects the ocular surface and is characterized by dryness, inflammation, pain, discomfort, and irritation. Dry eye is a complex, multifactorial disease which can present differently in patients, and becomes more common with age. Due to the prevalence of the disease, over one billion dollars is spent on treatment of the disease each year in the United States alone (IMS Health, 2013). One cause of the disease is inflammation of the ocular surface resulting from a patient’s immune response. Although physicians may prescribe topical steroid eye drops for the treatment of dry eye disease, chronic use of topical steroids can lead to elevations in intraocular pressure, which is a risk factor for glaucoma. Conversely, patients often do not reliably self-administer these drops, which can lead to eye irritation and continual, if not more, inflammation.
About Ocular Therapeutix’s Intracanalicular Plugs:
Ocular Therapeutix is developing the company’s proprietary absorbable polyethylene glycol hydrogel intracanalicular plug technology to release drugs in a sustained fashion over a specified period of time depending on the drug and its corresponding therapeutic need. At the end of the treatment period, the plug is designed to absorb, and exit the nasolacrimal system without need for removal by the physician. The plugs contain a visualization agent for retention monitoring throughout the treatment period.
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, allergic conjunctivitis, and dry eye disease. 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.
SOURCE: Ocular Therapeutix
Post Views: 110
