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Srilatha Vantipalli, Kenneth N Sall, Emil Stein, Howard Schenker, Jay Mulaney, Robert Smyth-Medina, Douglas Day, Robert Benza, El-Roy Dixon, Nicole Rissman, Jamie Lynne Metzinger, Michael H Goldstein; Evaluation of the Safety and Efficacy of OTX-TP, an intracanalicular travoprost insert, for the treatment of patients with open-angle glaucoma or ocular hypertension: A Phase 3 Study. Invest. Ophthalmol. Vis. Sci. 2020;61(7):3488.
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OTX-TP (travoprost ophthalmic insert) is a resorbable hydrogel-based insert delivering travoprost in a sustained-release fashion to the ocular surface over a 90-day period. Here we evaluate the safety and IOP-lowering efficacy of OTX-TP when placed in the canaliculus of the eyelid in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). This Phase 3 study was designed to assess a clinically meaningful response to treatment.
This was a prospective, multicenter Phase 3 trial. Patients diagnosed with OAG or OH were randomized (3:2) to receive in both eyes either OTX-TP or placebo vehicle insert (PV). Subjects completed follow-up visits at Weeks 2, 4, 6, 8, 10, 12 and 20. Primary endpoint was mean intraocular pressure (IOP) at 8AM, 10AM and 4PM at the 2, 6, and 12 Week visits. 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.
554 subjects with OAG or OH were enrolled at 50+ sites. OTX-TP treated subjects had a greater reduction in IOP from baseline relative to placebo insert at all 9 time points, and these differences were statistically significant (P<0.05) for eight of the nine time points. Reductions from baseline for OTX-TP treated subjects in this trial ranged from 3.27-5.72 mmHg across the 9 time points with higher levels of IOP reduction seen at the earlier time points in this trial. OTX-TP was generally well-tolerated and no ocular serious adverse events were observed. The most common ocular adverse events seen in the study eye were dacryocanaliculitis (approximately 7% in OTX-TP vs. 3% in placebo) and lacrimal structure disorder (approximately 6% in OTX-TP vs. 4% in placebo).
OTX-TP exhibits fair IOP lowering with a single insert, with a greater magnitude of effect early in the drug’s lifecycle. Adverse events were transient, mild and resolved over time.
This is a 2020 ARVO Annual Meeting abstract.
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