Glaukos has announced the US approval of its iDose TR implant for ocular hypertension (OHT) and open-angle glaucoma (OAG).
The US Food and Drug Administration (FDA) has approved the treatment for a single administration per eye.
Said to be the first of its kind, the implant is a prostaglandin analog indicated for the reduction of intraocular pressure that continuously delivers therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time.
“[This] approval ushers in a new era of interventional glaucoma therapy by enabling a more proactive and reliable approach for patients in need,” Mr Thomas Burns, Glaukos chairman and CEO, said.
“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 US affected by open-angle glaucoma and ocular hypertension.”
Dr John Berdahl, clinician and researcher at Vance Thompson Vision, said with the next generation of procedural pharmaceutical solutions for glaucoma, such as iDose TR, the industry now had a tool that will confront the standard practice of 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,” he said.
“The clinical data suggest that iDoseTR is not only effective with a favourable 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.”
The FDA approval is based on results from two randomised, multicentre Phase 3 clinical trials that achieved their primary efficacy endpoints through three months and favourable safety profiles through 12 months. In total, the Phase 3 trials randomised 1,150 subjects across 89 clinical sites.
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 control. Based on these outcomes, the FDA concluded that iDose TR demonstrated non-inferiority to control in IOP reduction during the first three months. The FDA also noted that subsequently iDose TR did not demonstrate non-inferiority over the next 9 months.
The approval is also supported by positive results from a Phase 2b clinical trial, which were highlighted in a peer-reviewed publication in Drugs.
“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,” the study authors concluded.
Glaukos intends to begin launching iDose TR in the latter part of the first quarter of 2024. The company has established a wholesale acquisition cost for iDose TR of approximately US$13,950 (AU$20,795), per implant.