June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Results of A Randomized, Double-Masked, Parallel-Arm Phase 2b Study Evaluating the Safety and Efficacy of OTX-TP (travoprost insert) Compared to Timolol Drops for the Treatment of Patients with Open-Angle Glaucoma or Ocular Hypertension
Author Affiliations & Notes
  • Christine Wilson
    Ocular Therapeutix, Bedford, Massachusetts, United States
  • Kenneth N Sall
    Sall Research Medical Center, Artesia, California, United States
  • Shamik Bafna
    Cleveland Eye Clinic, Elyria, Ohio, United States
  • Joseph P Gira
    Ophthalmology Consultants, St. Louis, Missouri, United States
  • Eugene B McLaurin
    Total Eye Care PA, Memphis, Tennessee, United States
  • Eugene Protzko
    Seidenberg Protzko Eye Associates, Havre de Grace, Maryland, United States
  • Reginald Sampson
    Hull Eye and Surgery Center, Lancaster, California, United States
  • Navin Tekwani
    Tekwani Vision Center, St. Louis, Missouri, United States
  • Michael Tepedino
    Cornerstone Eye Care, High Point, North Carolina, United States
  • Steven Vold
    Vold Vision, Fayetteville, Arkansas, United States
  • Thomas R Walters
    Texan Eye Care PA, Austin, Texas, United States
  • Jamie Lynne Metzinger
    Ocular Therapeutix, Bedford, Massachusetts, United States
  • Deepa Mulani
    Ocular Therapeutix, Bedford, Massachusetts, United States
  • Jonathan H Talamo
    Ocular Therapeutix, Bedford, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Christine Wilson, Ocular Therapeutix (E); Kenneth Sall, Ocular Therapeutix (F); Shamik Bafna, Ocular Therapeutix (F); Joseph Gira, Ocular Therapeutix (F); Eugene McLaurin, Ocular Therapeutix (F); Eugene Protzko, Ocular Therapeutix (F); Reginald Sampson, Ocular Therapeutix (F); Navin Tekwani, Ocular Therapeutix (F); Michael Tepedino, Ocular Therapeutix (F); Steven Vold, Ocular Therapeutix (F); Thomas Walters, Ocular Therapeutix (F); Jamie Lynne Metzinger, Ocular Therapeutix (E); Deepa Mulani, Ocular Therapeutix (E); Jonathan Talamo, Ocular Therapeutix (E)
  • Footnotes
    Support  Ocular Therapeutix supported this research.
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 2111. doi:
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      Christine Wilson, Kenneth N Sall, Shamik Bafna, Joseph P Gira, Eugene B McLaurin, Eugene Protzko, Reginald Sampson, Navin Tekwani, Michael Tepedino, Steven Vold, Thomas R Walters, Jamie Lynne Metzinger, Deepa Mulani, Jonathan H Talamo; Results of A Randomized, Double-Masked, Parallel-Arm Phase 2b Study Evaluating the Safety and Efficacy of OTX-TP (travoprost insert) Compared to Timolol Drops for the Treatment of Patients with Open-Angle Glaucoma or Ocular Hypertension. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2111.

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

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Abstract

Purpose : To evaluate the safety and IOP-lowering efficacy of OTX-TP, an extended release travoprost insert, when placed in the canaliculus of the eyelid in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study was designed to assess clinically meaningful response to treatment.

Methods : This was a prospective, multicenter Phase 2b trial. Patients diagnosed with OAG or OH were randomized (1:1) to receive either OTX-TP + placebo drops, or Timolol Maleate Ophthalmic Solution 0.5% + placebo vehicle insert (PV). Assigned drops were used twice daily at approximately 8h and 20h for the entire study. Subjects completed follow-up visits at Days 3, 15, 30, 45, 60, 75 and 90. Primary endpoints included the difference in mean change from baseline between treatment groups. Safety evaluations included adverse event (AE) collection and exam findings, including slit lamp, dilated fundus, visual acuity exams, grading of ocular hyperemia and subjective ocular comfort assessment.

Results : A total of 79 (OTX-TP, N=37; Timolol, N=42) subjects were randomized into the study. Demographic characteristics were similar in both treatment groups. IOP reductions from baseline were observed in both treatment groups at all 3 time points (8, 12 and 16h) at the Day 30, 60 and 90 Visits. Reductions in the OTX-TP group ranged from 2.30-5.11 mmHg and in the Timolol group, 5.28-7.23 mmHg, across 9 visits. Post-hoc analyses removing specific cohorts of patients reduced the performance difference between OTX-TP and Timolol. A similar percentage of subjects in both groups were reported to have experienced at least 1 ocular or non-ocular AE. The most frequently reported ocular AEs were dacryocanaliculitis, acquired dacryostenosis and eyelid edema. There were no deaths or other SAEs reported. Two OTX-TP subjects and 2 Timolol subjects discontinued study participation due to an ocular AE.

Conclusions : OTX-TP produced IOP reductions from baseline at Days 30, 60 and 90 and was safe and well tolerated. The performance of the Timolol cohort may have been enhanced by the presence of PV. A study design utilizing longer washout for OTX-TP subjects and absence of punctal occlusion in the presence of an active comparator may result in reduced differences between treatment groups.

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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