Glaukos gets FDA nod for iDose TR re-administration

 Glaukos (NYSE:GKOS) announced today that the FDA approved a new drug application (NDA) labeling supplement for its iDose TR system.

iDose TR (travoprost intracameral implant) offers the reduction of intraocular pressure (IOP). It treats patients with ocular hypertension (OHT) or open-angle glaucoma (OAG). The first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy. It continuously delivers 24/7 therapeutic levels of travoprost inside the eye for extended periods.

Glaukos designed iDose TR to improve the standard of care by addressing patient non-compliance issues. The implant also addresses the chronic side effects associated with topical glaucoma medications. iDose TR won FDA approval in late 2023.

The labeling supplement allows for re-administration of iDose TR using a repeat treatment protocol. Aliso Viejo, California-based Glaukos says it reflects accumulated clinical evidence supporting the safety and tolerability of repeat use for iDose TR.

Under the updated labeling, physicians can re-administer iDose TR more than once in patients who maintain a healthy cornea. This is defined by corneal endothelial cell density parameters. In clinical studies, the implant demonstrated a favorable long-term corneal safety profile. It delivered no clinically significant corneal endothelial cell loss over three years.

Additional clinical results demonstrated a safe, well-tolerated implant with a favorable safety profile over 12 months.

“We are pleased to announce this important labeling enhancement for iDose TR, which should help expand access for patients who may benefit from repeat treatment and provide physicians with greater flexibility in managing their glaucoma patients over time,” said Thomas Burns, Glaukos chair and CEO. “This approval further validates iDose TR’s established and proven safety profile and reinforces its leading position in addressing the strong and growing demand within the ophthalmic community for safe, effective, and sustained procedural pharmaceutical alternatives to traditional topical medications.”

https://www.drugdeliverybusiness.com/glaukos-fda-nod-idose-tr-readministration/