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RiLee Robeson, Rozemarijn S Verhoeven, Andres Garcia, Sanjib Das, Kristie Hamby, Melissa Hernandez, Glenwood G Gum, Benjamin R Yerxa, Tomas Navratil; A 12-Month Study of the ENV515 (Travoprost) Intracameral Implant on Intraocular Pressure in Beagle Dogs. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1072.
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ENV515 (travoprost) Intracameral Implant is a biodegradable extended-release polymer drug delivery system designed to address multiple shortcomings of current topical treatments for glaucoma Previously, the low dose formulation, ENV515-3, successfully demonstrated 6 months of IOP lowering effect in the Beagle dog, and 9 months of IOP lowering effect in humans. Currently, we are evaluating the full duration of action of the high dose formulation, ENV515-3-2, in the Beagle dog for up to 12 months in a non-GLP efficacy study.
High dose ENV515-3-2 (travoprost) implants were manufactured aseptically utilizing the PRINT© technology. Beagle dogs (3 males/group) were given a single bilateral intracameral administration of ENV515-3-2 (2 implants/eye) and were followed for up to 12 months. Animals were evaluated every two weeks for intraocular pressure (IOP).
Two ENV515-3-2 implants were successfully dosed in the Beagle dog. Following a single bilateral intracameral administration of 2 ENV515-3-2 (travoprost) implants, the high dose formulation demonstrated at least 7 months of IOP lowering with an average treatment effect of 38% (±4.0%) decrease in IOP from baseline, or an average decrease of 9.4 ±1.2 mmHg from baseline (24.7 mmHg).
A single bilateral intracameral administration of two ENV515 (travoprost) implants demonstrated at least 7 months of IOP lowering with an average treatment effect of 38% (±4.0%) decrease in IOP from baseline. Based on the previous correlation of efficacy between the Beagle dog and humans following the low dose ENV515-3 formulation, these high dose results in the Beagle dog suggest the potential for 12 months of IOP lowering effect in humans comparable to that achieved with topical Travatan Z.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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