IDose TR FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 9, 2024.
FDA Approved: Yes (First approved December 13, 2023)
Brand name: iDose TR
Generic name: travoprost
Dosage form: Intracameral Implant
Company: Glaukos Corporation
Treatment for: Glaucoma, Open Angle, Glaucoma/Intraocular Hypertension
iDose TR (travoprost intracameral implant) is a long-duration prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
- Open-angle glaucoma is thought to be caused by a blockage in the drainage angle in the eye, which leads to increased ocular pressure that can eventually cause damage to the optic nerve.
- iDose TR is an intracameral implant that continuously delivers therapeutic levels of travoprost inside the eye for extended periods of time. Travoprost was first approved as an ophthalmic solution formulation under the brand name Travatan for the treatment of open angle glaucoma or ocular hypertension in 2001. Travoprost is thought to reduce intraocular pressure by increasing uveoscleral outflow.
- FDA approval was based on the results of the GC-010 and GC-012 Phase 3 pivotal studies that compared single dose iDose TR to twice daily timolol ophthalmic solution 0.5%. IOP reductions with iDose TR were non-inferior to timolol over the first 3 months, but not non-inferior in the following 9 months. At 12 months, 81% of iDose TR subjects were completely free of IOP-lowering topical medications across both trials.
- iDose TR is administered intracamerally through a small, clear corneal incision and is anchored into the scleral tissue at the iridocorneal angle.
- Warnings and precautions associated with iDose TR include device dislocation and increased pigmentation of the iris.
- Common ocular adverse reactions include increases in intraocular pressure, iritis, dry eye, and visual field defects.
Development timeline for iDose TR
| Date | Article |
|---|---|
| Dec 14, 2023 | Approval FDA Approves iDose TR (travoprost intracameral implant) for the Treatment of Glaucoma |
Further information
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