Results Provide Encouraging Outlook for Extended Treatment of Glaucoma Patients
RESEARCH TRIANGLE PARK, NC, USA I October 17, 2016 I Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today released an interim analysis of its ENV515 (travoprost XR) phase 2 trial in glaucoma patients showing clinically meaningful reduction in intraocular pressure (IOP) for the entire nine-month evaluation period following a single administration. ENV515 also demonstrated an IOP lowering effect comparable to prestudy topical prostaglandin analogs (XALATAN® and LUMIGAN®) and in-study topical timolol maleate 0.5% ophthalmic solution (daily eye drops). Glaucoma is the leading cause of preventable vision loss and blindness due largely in part to poor patient compliance with once-daily eye drops.
“ENV515 continues to show great potential with a favorable safety profile and a sustained, clinically meaningful reduction in IOP over the initial nine months,” said Benjamin Yerxa, President of Envisia. “We plan to initiate enrollment in a new cohort of this phase 2 trial by year-end, which will enable us to evaluate the high dosage form of ENV515 that has been formulated with the goal of achieving efficacy comparable to TRAVATAN Z® with a duration greater than 9 months.”
The ongoing phase 2 trial is a 12-month safety and efficacy evaluation that enrolled five glaucoma patients at sites within the U.S. The pre-washout baseline for all patients in this cohort, treated with LUMIGAN or XALATAN prior to enrollment, was 19.7 mmHg, with a post-washout baseline of 26.1 mmHg for 8 AM IOP. Single low dose of ENV515 decreased the mean + SD 8 AM IOP by 6.7 ± 3.8 mmHg or 26 percent over nine months (mean of all 8 AM IOPs over nine months). The mean 8 AM IOP after a single low dose of ENV515 was 19.4 mmHg over the nine-month period. ENV515 was well tolerated and there were no serious adverse events, no changes in corneal endothelial cell counts evaluated by an independent reading center, and no changes in corneal thickness. The most common adverse event was early-onset transient hyperemia, or eye redness, related to the dosing procedure.
“These nine-month results are very promising and continue to validate Envisia’s novel extended-delivery approach,” said Dr. Thomas Walters, MD, the lead investigator for the ENV515 phase 2 trial. “Based on these results, ENV515 has the potential to change the way we treat glaucoma in the majority of our patients and to potentially provide the type of efficacy, safety and compliance that is needed to prevent disease progression.”
ABOUT ENVISIA THERAPEUTICS™
Envisia Therapeutics is a privately held biotechnology company focused on the development of novel ocular therapies. Envisia is leveraging the unique and powerful properties of the PRINT® technology to develop therapies for a variety of ocular conditions, beginning with ENV515 for glaucoma. ENV515 is a novel, extended-release formulation of a marketed prostaglandin analogue with the potential to significantly limit disease progression and vision loss through improved product performance and patient compliance. Envisia is actively exploring the use of the company’s unique technology to develop products for other important ocular diseases including age-related macular degeneration (AMD), diabetic macular edema (DME), and ocular inflammation. Envisia is located in Research Triangle Park, North Carolina. For more information, please go to www.envisiatherapeutics.com.
SOURCE: Envisia Therapeutics
Post Views: 120
Results Provide Encouraging Outlook for Extended Treatment of Glaucoma Patients
RESEARCH TRIANGLE PARK, NC, USA I October 17, 2016 I Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today released an interim analysis of its ENV515 (travoprost XR) phase 2 trial in glaucoma patients showing clinically meaningful reduction in intraocular pressure (IOP) for the entire nine-month evaluation period following a single administration. ENV515 also demonstrated an IOP lowering effect comparable to prestudy topical prostaglandin analogs (XALATAN® and LUMIGAN®) and in-study topical timolol maleate 0.5% ophthalmic solution (daily eye drops). Glaucoma is the leading cause of preventable vision loss and blindness due largely in part to poor patient compliance with once-daily eye drops.
“ENV515 continues to show great potential with a favorable safety profile and a sustained, clinically meaningful reduction in IOP over the initial nine months,” said Benjamin Yerxa, President of Envisia. “We plan to initiate enrollment in a new cohort of this phase 2 trial by year-end, which will enable us to evaluate the high dosage form of ENV515 that has been formulated with the goal of achieving efficacy comparable to TRAVATAN Z® with a duration greater than 9 months.”
The ongoing phase 2 trial is a 12-month safety and efficacy evaluation that enrolled five glaucoma patients at sites within the U.S. The pre-washout baseline for all patients in this cohort, treated with LUMIGAN or XALATAN prior to enrollment, was 19.7 mmHg, with a post-washout baseline of 26.1 mmHg for 8 AM IOP. Single low dose of ENV515 decreased the mean + SD 8 AM IOP by 6.7 ± 3.8 mmHg or 26 percent over nine months (mean of all 8 AM IOPs over nine months). The mean 8 AM IOP after a single low dose of ENV515 was 19.4 mmHg over the nine-month period. ENV515 was well tolerated and there were no serious adverse events, no changes in corneal endothelial cell counts evaluated by an independent reading center, and no changes in corneal thickness. The most common adverse event was early-onset transient hyperemia, or eye redness, related to the dosing procedure.
“These nine-month results are very promising and continue to validate Envisia’s novel extended-delivery approach,” said Dr. Thomas Walters, MD, the lead investigator for the ENV515 phase 2 trial. “Based on these results, ENV515 has the potential to change the way we treat glaucoma in the majority of our patients and to potentially provide the type of efficacy, safety and compliance that is needed to prevent disease progression.”
ABOUT ENVISIA THERAPEUTICS™
Envisia Therapeutics is a privately held biotechnology company focused on the development of novel ocular therapies. Envisia is leveraging the unique and powerful properties of the PRINT® technology to develop therapies for a variety of ocular conditions, beginning with ENV515 for glaucoma. ENV515 is a novel, extended-release formulation of a marketed prostaglandin analogue with the potential to significantly limit disease progression and vision loss through improved product performance and patient compliance. Envisia is actively exploring the use of the company’s unique technology to develop products for other important ocular diseases including age-related macular degeneration (AMD), diabetic macular edema (DME), and ocular inflammation. Envisia is located in Research Triangle Park, North Carolina. For more information, please go to www.envisiatherapeutics.com.
SOURCE: Envisia Therapeutics
Post Views: 120
