Glaukos Receives FDA Approval of iDose TR Intracameral Implant

Glaukos received FDA approval for the iDose TR (travoprost intracameral implant 75 mcg), a first-of-its-kind, prostaglandin analog intracameral implant indicated for the reduction of IOP in patients with ocular hypertension or open-angle glaucoma.

The iDose TR procedure, which is approved for one administration per eye, is designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time. iDose TR is intended to improve the standard of care by addressing the ubiquitous patient non-compliance issues and chronic side effects associated with topical glaucoma medications.

Glaukos intends to commence initial commercial launch activities for iDose TR in the latter part of the first quarter of 2024. Glaukos has established a wholesale acquisition cost for iDose TR of $13,950 per dose (or implant).

“The FDA approval of iDose TR represents a significant milestone for Glaukos following an extensive pioneering journey since the inception of the original idea nearly 15 years ago. Today’s approval ushers in a new era of interventional glaucoma therapy by enabling a more proactive and reliable approach for patients in need,” Thomas Burns, Glaukos chairman and chief executive officer, said in a company news release. “We believe iDose TR can be a transformative, novel technology able to fundamentally improve the treatment paradigm for patients with open-angle glaucoma or ocular hypertension. We are grateful to the clinical investigators and study participants in the clinical trials for their instrumental roles in helping us reach this important advancement for glaucoma patient care. At Glaukos, we are relentlessly focused on delivering novel therapies for chronic eye diseases and now iDose TR has the potential to redefine the standard of care for patients in the U.S. affected by open-angle glaucoma and ocular hypertension.”

The FDA approval is based on results from two prospective, randomized, multicenter, 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 randomized 1,150 subjects across 89 clinical sites. The FDA approval and phase 3 data referenced below is for the slow-release iDose TR model, consistent with the company’s NDA submission and commercialization plans.

Both phase 3 trials successfully achieved the prespecified primary efficacy endpoints through 3 months and demonstrated a favorable tolerability and safety profile through 12 months. IOP reductions from baseline over the first 3 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 8 a.m. and 10 a.m. at Day 10, Week 6 and Month 3). Based on these outcomes, the FDA concluded in the prescribing information that iDose TR demonstrated noninferiority to timolol ophthalmic solution in IOP reduction during the first 3 months. The FDA also noted that subsequently iDose TR did not demonstrate noninferiority over the next 9 months, according to Glaukos. 

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 intraocular pressure, 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 (link here). 

Alongside the iDose TR approval announcement, Glaukos has introduced the iDose Your Dose Initiative. For every iDose TR sold, Glaukos pledges to make available an equal number of iDose TR units for qualifying charitable donation requests in the US and around the globe for recipients that satisfy independent eligibility requirements.

For more information about iDose TR and full prescribing information, visit www.iDoseTRhcp.com.