Glaukos has announced the approval by the United States Food and Drug Administration (FDA) of iDose TR, a travoprost intracameral implant to treat glaucoma.
Glaukos said iDose TR is a first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time.
It is intended to improve the standard of care by addressing the patient non-compliance issues and chronic side effects associated with topical glaucoma medications.
FDA approval was based on robust Phase 3 clinical program consisting of two pivotal studies that randomised 1,150 subjects across 89 clinical sites, Glaukos said in a news release.1
“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,” said Dr John Berdahl, clinician and researcher at Vance Thompson Vision.
Reference
- Glaukos, Glaukos Announces FDA Approval of iDose®TR (travoprost intracameral implant), news release 14 December 2023, available at: glaukos.com/investors/news/news-details/2023/Glaukos-Announces-FDA-Approval-of-iDoseTR-travoprost-intracameral-implant/default.aspx [accessed 15 Dec 2023].
