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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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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.
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.
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.
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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