iDose TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG) has been given the green light by the United States Food and Drug Administration (FDA).
Approval was granted for a New Drug Application (NDA) for a single administration per eye.
Developed by Glaukos, iDose TR is a first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time. It is intended to improve the standard of care by addressing ubiquitous patient non-compliance issues and chronic side effects associated with topical glaucoma medications.
Thomas Burns, Glaukos chairman and chief executive officer said the “approval ushers in a new era of interventional glaucoma therapy by enabling a more proactive and reliable approach for patients in need.”
Glaukos believes iDose TR “can be a transformative, novel technology able to fundamentally improve the treatment paradigm for patients with open-angle glaucoma or ocular hypertension”.
Safety and Efficacy Evidence
The FDA approval is based on results from two prospective, randomised, multicentre, double-masked, phase 3 pivotal trials (GC-010 and GC-012) designed to compare the safety and efficacy of a single administration of one of two iDose TR models with different travoprost release rates (referred to as the fast- and slow-release iDose TR models, respectively) to topical timolol ophthalmic solution, 0.5% BID (twice a day), in reducing IOP in subjects with open-angle glaucoma or ocular hypertension. In total, the Phase 3 trials randomised 1,150 subjects across 89 clinical sites.
Both phase 3 trials successfully achieved the pre-specified primary efficacy endpoints through three months and demonstrated a favourable tolerability and safety profile through 12 months. IOP reductions from baseline over the first three months were 6.6-8.4 mmHg in the iDose TR arm, versus 6.5-7.7 mmHg in the timolol control arm (mmHg range represents IOP reduction means across the six U.S. FDA pre-specified timepoints of 8am and 10 am at day 10, week six, and month three). Based on these outcomes, the FDA concluded in the prescribing information that iDose TR demonstrated non-inferiority to timolol ophthalmic solution in IOP reduction during the first three months. The FDA also noted that subsequently, iDose TR did not demonstrate non-inferiority over the next nine months.
At 12 months, 81% of iDose TR subjects were completely free of IOP-lowering topical medications across both trials. In both trials, iDose TR demonstrated excellent tolerability and subject retention with 98% of iDose TR subjects continuing in the trial at 12 months, versus 95% of timolol control subjects. In controlled studies, the most common ocular adverse reactions reported in 2% to 6% of iDose TR patients were increases in IOP, iritis, dry eye, and visual field defects, most of which were mild and transient in nature.
iDose TR is also supported by positive results from a phase 2b clinical trial, which were recently highlighted in a peer-reviewed publication in Drugs. The study authors concluded, “The travoprost intraocular implant demonstrated robust IOP-lowering and substantially reduced topical IOP-lowering medication burden for up to 36 months following a single administration, while maintaining a favourable safety profile.”
Glaukos intends to commence initial commercial launch activities for iDose TR in the latter part of the first quarter of 2024.
