July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
A Prospective, Multicenter, Open-Label First-in-Human Study to Evaluate the Safety, Tolerability and Efficacy of OTX-TIC (travoprost) Implant in Subjects with Primary Open-Angle Glaucoma or Ocular Hypertension: Preliminary Findings
Author Affiliations & Notes
  • Michael H Goldstein
    Ocular Therapeutix, Bedford, Massachusetts, United States
    Ophthalmology, New England Eye Center, Boston, Massachusetts, United States
  • Thomas Walters
    Texan Eye Care, Texas, United States
  • Damien F. Goldberg
    Wolstan & Goldberg Eye Associates, California, United States
  • Douglas Day
    Woolfson Eye Institute, Georgia, United States
  • Elizabeth Braun
    Ocular Therapeutix, Bedford, Massachusetts, United States
  • Jamie L Metzinger
    Ocular Therapeutix, Bedford, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Michael Goldstein, Ocular Therapeutix (E); Thomas Walters, Ocular Therapeutix (F); Damien Goldberg, Ocular Therapeutix (F); Douglas Day, Ocular Therapeutix (F); Elizabeth Braun, Ocular Therapeutix (E); Jamie L Metzinger, Ocular Therapeutix (E)
  • Footnotes
    Support  Ocular Therapeutix
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 3360. doi:
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      Michael H Goldstein, Thomas Walters, Damien F. Goldberg, Douglas Day, Elizabeth Braun, Jamie L Metzinger; A Prospective, Multicenter, Open-Label First-in-Human Study to Evaluate the Safety, Tolerability and Efficacy of OTX-TIC (travoprost) Implant in Subjects with Primary Open-Angle Glaucoma or Ocular Hypertension: Preliminary Findings. Invest. Ophthalmol. Vis. Sci. 2019;60(9):3360.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : The study evaluated the safety, tolerability and efficacy of a single sustained release dose of the OTX-TIC implant, delivered via intracameral injection.

Methods : OTX-TIC is a bioresorbable intracameral implant of travoprost encapsulated in microparticles in a hydrogel matrix. OTX-TIC was injected in 1 eye of 5 adult subjects and the other eye received topical travoprost eye drops. Diurnal intraocular pressure (IOP) was captured at predetermined time points for up to 9 months. Safety assessments, including slit lamp examination, specular microscopy, implant position, and patient-reported comfort was also collected.

Results : OTX-TIC produced a sustained IOP lowering effect for up to 7 months, compared to baseline IOP. IOP lowering was seen in all subjects as early as 3 days following injection. Changes in baseline in eyes receiving the OTX-TIC implant were similar to travoprost eye drop treated eyes. In all subjects, the implant remained localized to the inferior anterior chamber. Endothelial cell counts were followed. No subjects developed CME or loss of vision. The hydrogel implant was not visible after 5-7 months.

Conclusions : Intracameral treatment of OTX-TIC has the potential to achieve a clinically-meaningful IOP lowering effect for up to 7 months with a single dose. The implant resorbs over 5-7 months and localizes to the inferior anterior chamber. Adverse events were minimal and mild and resolved over the course of the study.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

 

Implant resorption over the study period; (top, left to right) Days 1, 14, 28, and (bottom) Month 4, 5, 6

Implant resorption over the study period; (top, left to right) Days 1, 14, 28, and (bottom) Month 4, 5, 6

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