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Steven L Mansberger, Jinny Conley, Rozemarijn S Verhoeven, Kristin Blackwell, Michael Depenbusch, Tracey Knox, Thomas R Walters, Iqbal Ahmad, Benjamin R Yerxa, Tomas Navratil; Interim Analysis of Low Dose ENV515 Travoprost XR with 11 Month Duration Followed by Dose Escalation and 28 Day Efficacy Evaluation of High Dose ENV515. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2110. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
ENV515 travoprost XR is an extended release formulation using nano- and microparticle engineering PRINT technology and a fully biodegradable polymer drug delivery system. Previously, ENV515 demonstrated 8 months of intraocular pressure (IOP) lowering effect after a single dose in nonclinical studies in dogs and sustained IOP lowering effect over 28 days after a single dose in glaucoma patients. To further evaluate ENV515, a 12-month dose escalation study was initiated with low and high doses of ENV515 using a single intracameral administration.
We enrolled 5 glaucoma patients in a 12-month Phase 2 study of low dose ENV515, and 10 glaucoma patients in a 12-month cohort of high dose ENV515. All enrolled patients were topical prostaglandin analogue (PGA) users at the time of enrollment. After washout, patients were administered a single low or high dose ENV515 in the study eye with timolol maleate 0.5% BID used as active comparator in the contralateral eye. We report 11-month interim analysis of low dose ENV515, and compare the 28-day response of the low vs. high dose of ENV515.
In the low dose cohort, the mean IOP ± SD at the pre-washout visit on a PGA analogue was 19.7 ± 2.7 mmHg, with a post-washout baseline IOP of 26.1 ± 2.2 mmHg at 8 AM. ENV515 decreased the mean ± SD 8 AM IOP from baseline by 6.7 ± 3.7 mmHg (p < 0.005) or 25% over 11 months (mean of all 8 AM IOPs over 11 months). The mean 8 AM IOP after a single low dose of ENV515 was 19.5 mmHg over the 11-month period. There were no serious adverse events and the most common adverse event was early-onset transient hyperemia related to the dosing procedure. The high dose ENV515 demonstrated 1.1 mmHg better IOP lowering effect at 28 days when compared to the low dose ENV515.
Low dose ENV515 was well tolerated over 11 months, and demonstrated sustained IOP-lowering effect for 11 months following a single dose. High dose ENV515 demonstrated a potential to elicit a greater treatment effect compared to the low dose at 28 days and is currently being evaluated for sustained long-term IOP lowering effect.
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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