Glaukos’ iDose TR Ophthalmic Implant OK’ed

Glaukos has received U.S. Food and Drug Administration (FDA) approval for a single administration per eye of iDose TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated to reduce intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).
 
iDose TR is a long-duration, intracameral procedural therapy that delivers 24/7 therapeutic levels of travoprost inside the eye for extended periods of time. It aims to address the ever-present patient non-compliance issues and chronic side effects related to topical glaucoma medications.
 
“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,” said Thomas Burns, Glaukos chairman and CEO. “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 approval is based on results from two Phase 3 pivotal trials comparing fast-and slow-release iDose TR models with topical ophthalmic solution to reduce IOP in subjects with OAG or OHT. 1,150 subjects were evaluated and both trials achieved primary efficacy endpoints through three months.
 
iDose TR demonstrated non-inferiority to timolol ophthalmic solution in IOP reduction during the first three months, as well. Glaukos intends to begin commercial launch activities for iDose TR in the latter part of Q1 2024.
 
“With the next generation of procedural pharmaceutical solutions for glaucoma such as iDose TR, we now have a new tool that will confront the standard legacy practice of relying on topical drops, which are known to cause uncomfortable side effects and present a myriad of challenges such as treatment adherence, complex dosing regimens, and difficulty with self-administration,” said John Berdahl, MD, clinician and researcher at Vance Thompson Vision. “The clinical data suggest that iDose TR is not only effective with a favorable safety profile, but it has potential to relieve patients from the burdens of prescription eye drops for an extended period of time. I look forward to adding this novel therapy into my treatment toolbox for the benefit of my patients.”