A Phase 3 clinical trial evaluated the safety and efficacy of the travoprost intraocular implant for patients with open-angle glaucoma or ocular hypertension. The trial tested fast-eluting and slow-eluting versions of the implant compared to timolol drops in reducing intraocular pressure.

While IOP-lowering medications are often the initial choice for patients with elevated IOP, medications in drop form present problems for patients including issues with instilling the drops accurately, to a wide array of challenges that cause decreased adherence. “Nearly 50% of patients discontinue the initially prescribed topical IOP-lowering medications completely within 6 months, and some 90% of patients intermittently fail to refill the prescriptions over a 3-year period,” the researchers explain in their recent article in Ophthalmology. “Poor adherence to topical IOP-lowering medication has been shown to be associated with glaucomatous visual field progression. [However,] sustained-release drug delivery systems that are readministered periodically have the potential to alleviate the issue of poor adherence.”

The travoprost intraocular implant presents one such possibility. This Phase 3 trial followed patients at 10 days, 6 weeks, and 3 months after receiving the implant to monitor the IOP-lowering effects of both fast- and slow-eluting versions. The trial included 540 patients with open-angle glaucoma or ocular hypertension who were randomly assigned to one of three groups: fast-eluting (FE) implant, slow-eluting (SE) implant, or timolol drops.

The investigators found both implant models demonstrated significant reductions in IOP, ranging from 6.6 to 8.5 mmHg over 3 months, comparable to timolol (6.5 to 7.7 mmHg). Also, only 5.1% of the FE group and 4.2% of the SE group required additional IOP-lowering medications at month 3, compared to 7% of patients who received timolol.

Iritis and ocular hyperemia were the most frequent adverse events. Cases were generally mild or moderate, though adverse events were more common overall in the implant groups vs. the timolol group. Device dislocation occurred in 0.5% of patients in either implant group, and one case of endophthalmitis occurred in the SE implant group.

While the trial includes only 3 months so far, it remains ongoing to analyze long-term efficacy and safety data after 3 years.

“This study indicated that both models of the travoprost intraocular implant provide clinically relevant, sustained IOP reductions over the 3-month period after a single administration that are noninferior to those produced by twice-daily administered timolol ophthalmic solution 0.5%,” the researchers conclude, noting that the travoprost implant offers a potential alternative for patients who struggle with adherence to daily drop therapy.

A full list of author disclosures can be found in the published research.