Study shows sustained effect, high tolerability of drug-eluting insert for glaucoma
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The OTX-TP travoprost insert showed durable IOP-lowering effect over 12 weeks and a low incidence of the commonly reported side effects of travoprost drops.
The OTX-TP insert (Ocular Therapeutix) was developed with the aim of improving adherence, a critical unmet need with current drop therapies, Srilatha Vantipalli, PhD, said in a study presented at the virtual Association for Research in Vision and Ophthalmology meeting.
“Other issues with chronic use of drops include side effects, for example, hyperemia with travoprost eye drops, difficulty with self-administration and frequent hand-face contact that can potentially increase the risk of infection, especially in this COVID era,” she said.
The insert is delivered through the lacrimal punctum into the canaliculus and is designed for sustained delivery of preservative-free travoprost microparticles over 12 weeks. It is made of a highly biocompatible hydrogel material conjugated with fluorescein to allow monitoring of its presence at all times.
“Once the drug is eluted completely, it does not need to be removed but dissolves completely and flashes down the nasolacrimal duct,” Vantipalli said.
The double-masked, vehicle-controlled phase 3 study was designed to evaluate the safety and IOP-lowering efficacy of the insert in patients with open-angle glaucoma or ocular hypertension. A total of 554 subjects were randomly assigned to receive OTX-TP or placebo vehicle insert and were followed for 12 weeks.
“Subjects receiving the intracanalicular OTX-TP insert achieved statistically significant superiority in mean reduction of IOP compared to vehicle. Reduction of IOP from baseline ranged from 3 mm Hg to 6 mm Hg with higher IOP reduction at the earlier time points, within the first 6 months,” Vantipalli said.
The insert was generally well tolerated with no serious ocular adverse event and a similar safety profile between the two groups. The most common adverse events were dacryocanaliculitis and lacrimal structure disorders. A low incidence of the most common side effects of travoprost, including hyperemia and pigmentation of the eyelids, was reported.
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Vantipalli S, et al. 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. Presented at: Association for Research in Vision and Ophthalmology annual meeting; June 12, 2020 (virtual meeting).
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