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Introduction <p>To determine the aqueous humor (AH) exposure to travoprost free acid (TFA) and the in vivo elution rate of travoprost over a 24-month period in subjects with open-angle glaucoma administered a travoprost intracameral implant, 75 µg.</p> Methods <p>In this prospective, single-center, open-label study, 210 subjects (7 cohorts of 30 subjects each) were administered a travoprost intracameral implant and followed for 3–24 months. At pre-determined timepoints (3, 6, 12, 15, 18, 21, and 24 months), AH was collected, a new implant was administered, and the prior implant removed. AH samples were assayed for TFA concentrations using a validated liquid chromatography-tandem mass spectrometry method. Explants were analyzed for remaining travoprost using a validated high-performance liquid chromatography method.</p> Results <p>Mean AH concentrations of TFA were 5.0, 3.7, 5.6, 2.0, 2.2, 3.8, and 3.3 ng/mL at 3, 6, 12, 15, 18, 21, and 24 months, respectively, post-administration. Mean percent travoprost remaining in explants was approximately 79%, 70%, 50%, 39%, 35%, 28%, and 16% at 3, 6, 12, 15, 18, 21 and 24 months, respectively, post-administration.</p> Conclusions <p>Concentrations of TFA in AH through month 24 were above the established efficacious concentration of 0.1 ng/mL for intracameral implants, indicating that adequate TFA levels were achieved to elicit maximal intraocular pressure (IOP)-lowering efficacy, and supported by low levels of IOP in subjects through 24 months. The remaining dose of travoprost in explants at 24 months (i.e., 16%) indicates the potential for efficacious drug delivery beyond 2 years.</p> Trial Registration Number <p>Clinical Trials.gov Identifier: NCT06582732 (31 August 2024: retrospectively registered).</p>

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Aqueous Humor Concentrations of Travoprost Free Acid and Residual Drug in Explanted Implants from Patients Administered a Travoprost Intracameral Implant

  • 期刊论文

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  • 发表日期：

    2025年3月24日

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  • Gabriella Szekely,
  • Lilit A. Voskanyan,
  • Kerry G. Stephens,
  • Long V. Doan,
  • Jennifer R. Seal,
  • Mohammed K. ElMallah,
  • Todd Fjield,
  • David Applegate,
  • Dale W. Usner,
  • L. Jay Katz,
  • Angela C. Kothe,
  • Tomas Navratil

摘要

Introduction

To determine the aqueous humor (AH) exposure to travoprost free acid (TFA) and the in vivo elution rate of travoprost over a 24-month period in subjects with open-angle glaucoma administered a travoprost intracameral implant, 75 µg.

Methods

In this prospective, single-center, open-label study, 210 subjects (7 cohorts of 30 subjects each) were administered a travoprost intracameral implant and followed for 3–24 months. At pre-determined timepoints (3, 6, 12, 15, 18, 21, and 24 months), AH was collected, a new implant was administered, and the prior implant removed. AH samples were assayed for TFA concentrations using a validated liquid chromatography-tandem mass spectrometry method. Explants were analyzed for remaining travoprost using a validated high-performance liquid chromatography method.

Results

Mean AH concentrations of TFA were 5.0, 3.7, 5.6, 2.0, 2.2, 3.8, and 3.3 ng/mL at 3, 6, 12, 15, 18, 21, and 24 months, respectively, post-administration. Mean percent travoprost remaining in explants was approximately 79%, 70%, 50%, 39%, 35%, 28%, and 16% at 3, 6, 12, 15, 18, 21 and 24 months, respectively, post-administration.

Conclusions

Concentrations of TFA in AH through month 24 were above the established efficacious concentration of 0.1 ng/mL for intracameral implants, indicating that adequate TFA levels were achieved to elicit maximal intraocular pressure (IOP)-lowering efficacy, and supported by low levels of IOP in subjects through 24 months. The remaining dose of travoprost in explants at 24 months (i.e., 16%) indicates the potential for efficacious drug delivery beyond 2 years.

Trial Registration Number

Clinical Trials.gov Identifier: NCT06582732 (31 August 2024: retrospectively registered).