September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Completed 28-Day and Ongoing 12-Month Safety and Efficacy Evaluation of ENV515 (travoprost) Intracameral Implant in Phase 2 Study
Author Affiliations & Notes
  • Thomas R Walters
    Texan Eye/Keystone Research,, Austin, Texas, United States
  • Tomas Navratil
    Envisia Therapeutics, Research Triangle Park, North Carolina, United States
  • Stacey Pittman
    Envisia Therapeutics, Research Triangle Park, North Carolina, United States
  • Virginia Conley
    Envisia Therapeutics, Research Triangle Park, North Carolina, United States
  • Leo Trevino
    Envisia Therapeutics, Research Triangle Park, North Carolina, United States
  • Bruce E Silverstein
    Shasta Eye Medical Group, Redding, California, United States
  • Michael Depenbusch
    Arizona Eye Center, Phoenix, Arizona, United States
  • Steven L Mansberger
    Devers Eye Institute, Portland, Oregon, United States
  • Rhett Schiffman
    Envisia Therapeutics, Research Triangle Park, North Carolina, United States
  • Footnotes
    Commercial Relationships   Thomas Walters, Envisia Therapeutics (C); Tomas Navratil, Envisia Therapeutics (E), Envisia Therapeutics (P), Envisia Therapeutics (I); Stacey Pittman, Envisia Therapeutics (E); Virginia Conley, Envisia Therapeutics (E); Leo Trevino, Envisia Therapeutics (E); Bruce Silverstein, Envisia Therapeutics (F); Michael Depenbusch, Envisia Therapeutics (F); Steven Mansberger, Envisia Therapeutics (F), Envisia Therapeutics (C); Rhett Schiffman, Envisia Therapeutics (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3025. doi:
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      Thomas R Walters, Tomas Navratil, Stacey Pittman, Virginia Conley, Leo Trevino, Bruce E Silverstein, Michael Depenbusch, Steven L Mansberger, Rhett Schiffman; Completed 28-Day and Ongoing 12-Month Safety and Efficacy Evaluation of ENV515 (travoprost) Intracameral Implant in Phase 2 Study. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3025.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Purpose : ENV515 (travoprost) Intracameral Implant is an extended release formulation of travoprost using a biodegradable polymer drug delivery system. Previously, ENV515 demonstrated 8 months of IOP lowering effect in nonclinical studies in dogs. To effectively evaluate different doses and implant sizes and shapes of ENV515 in preparation for Ph2b/3 clinical studies, initial 28-day safety and efficacy evaluation in Phase 2 Cohort 1 was completed and long-term efficacy and safety evaluation of ENV515 was initiated in Cohort 2.

Methods : To evaluate the initial safety and IOP-lowering efficacy of intracameral ENV515 over 28 days, 21 glaucoma patients scheduled for cataract surgery were enrolled in Cohort 1 of ENV515-01 Phase 2 study of single intracameral administration of ENV515. Based on the outcome of Cohort 1, dosing ranging 12-month evaluation of ENV515 in glaucoma patients without cataract was initiated starting with low dose of ENV515-3 (Cohort 2), with planned follow-on Cohorts 3 and 4 studying higher doses and different sizes and shapes within this ongoing Phase 2 trial.

Results : We report interim results of an ongoing Phase 2 clinical study, with final results from the completed 28-day Cohort 1 and interim study progress of an ongoing 12-month Cohort 2. In the 28-day Cohort 1 study, ENV515, administered as a single dose, achieved its primary efficacy endpoint defined as change from baseline in average diurnal IOP at Day 25 in all 4 studied dose levels. ENV515-3 high dose demonstrated 6.7 mmHg or 28% decrease from baseline (p<0.001, n=10), which was comparable to once-daily TRAVATAN Z® (6.6 mmHg or 28% decrease from baseline, n=21) administered to the non-study eye. The most common adverse event was early-onset transient hyperemia, or eye redness, which was related to the dosing procedure. Based on this outcome, 12-month long term evaluation of safety and efficacy was initiated and first patients enrolled across 3 clinical sites in US.

Conclusions : ENV515 demonstrated robust and sustained IOP-lowering effect with good safety and tolerability for 28-days following a single dose administered via intracameral injection. These results enabled advancement of ENV515 into 12-month efficacy and safety evaluation in preparation for Phase 2b/3 clinical studies.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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