Glaukos Receives FDA Approval for iDose TR Intracameral Implant

Glaukos has received FDA approval for iDose TR (travoprost intracameral implant 75 mcg), a groundbreaking prostaglandin analog intracameral implant designed to reduce intraocular pressure (IOP) in individuals with ocular hypertension or open-angle glaucoma.

The iDose TR procedure, sanctioned for a single administration per eye, is crafted to provide continuous, around-the-clock delivery of therapeutic levels of a proprietary travoprost formulation within the eye for prolonged durations. This innovative approach aims to elevate the standard of care by mitigating patient non-compliance issues and chronic side effects often associated with topical glaucoma medications.

Anticipating an initial commercial launch in the latter part of the first quarter of 2024, Glaukos has established a wholesale acquisition cost for iDose TR at $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.,” Mr. Burns added.

The Study

FDA approval for iDose TR is based on outcomes from two prospective, randomized, multicenter, double-masked, phase 3 pivotal trials (GC-010 and GC-012). These trials aimed to evaluate the safety and efficacy of a single administration of two iDose TR models—distinguished by different travoprost release rates—against topical timolol ophthalmic solution, 0.5% BID (twice a day), in reducing IOP in subjects with open-angle glaucoma or ocular hypertension. With a total of 1,150 subjects across 89 clinical sites, the slow-release iDose TR model, consistent with the company’s NDA submission, garnered FDA approval.

Both phase 3 trials met primary efficacy endpoints at 3 months, displaying favorable tolerability and safety profiles through 12 months. IOP reductions from baseline over the initial 3 months favored iDose TR, demonstrating noninferiority to timolol ophthalmic solution, but subsequent noninferiority was not established over the next 9 months. At 12 months, 81% of iDose TR subjects were medication-free, and the trials showcased excellent tolerability and subject retention.

In controlled studies, common ocular adverse reactions (2-6% of iDose TR patients) were generally mild and transient. Supported by positive results from a phase 2b clinical trial, iDose TR introduces the iDose Your Dose Initiative—pledging to donate an equal number of iDose TR units for charitable causes with each sale.