iDose TR contains a novel formulation of travoprost, a prostaglandin analog used to reduce intraocular pressure (IOP). Glaukos designed it to continuously release therapeutic levels of medication for at least one year. Once all travoprost is released, iDose TR is removed and replaced with an implant, potentially offering an alternative to daily eye drop treatment.
Aliso Viejo, California-based Glaukos announced topline data for two separate Phase 3 pivotal trials of iDose TR. The data demonstrated the achievement of pre-specified primary efficacy endpoints through three months in both trials. It also demonstrated excellent tolerability and a favorable safety profile through 12 months.
The fast- and slow-release iDose TR arms in both trials showed non-inferiority to the active comparator arm (twice-daily topical timolol ophthalmic solution, 0.5%) through 3 months. Additionally, 93% of slow-release subjects remained well-controlled on the same or fewer IOP-lowering topical medications at 12 months compared to screening after a single iDose TR administration. This compares to 67% of timolol control subjects in both trials.
Glaukos said 81% of slow-release iDose TR subjects were free of the topical medications at 12 months. iDose TR also produced no adverse events of corneal endothelial cell loss, no serious corneal adverse events. There were no adverse events of periorbital fat atrophy.
Conjunctival hyperemia occurred at a low rate of 3% for slow-release subjects, Glaukos said. The most frequent adverse event for slow-release subjects was mild transient iritis (6% rate). In-office administration was successfully employed as well.
“We are very pleased to announce these robust and replicative positive Phase 3 pivotal data results for iDose TR, which mark a major milestone for our company and powerfully reaffirms our view that iDose TR can be a transformative novel technology able to fundamentally improve the glaucoma treatment paradigm for patients,” Glaukos Chair and CEO Thomas Burns said in a news release. “We believe there is an important unmet clinical need and strong appetite within the ophthalmic community for safe, effective and sustained dropless pharmaceutical alternatives to traditional topical medications.
Glaukos iDose TR clinical trial details
Based on the data, Glaukos intends to submit to the FDA for the slow-release model. It expects FDA review and decision will be complete by the end of 2023.
The clinical program includes two prospective, randomized, double-masked pivotal clinical trials. The trials compared safety and efficacy for the two iDose TR models to the topical timolol solution. The first of the two trials randomized 590 subjects, while the second had 560. The total of 1,150 subjects ranged across 89 clinical sites.
“These data leave us ideally positioned for an upcoming NDA submission and FDA review for iDose TR as we continue to advance our mission to transform vision for the benefit of patients around the globe suffering from chronic eye diseases,” said Burns.
