FDA approves iDose TR for glaucoma, ocular hypertension
Click Here to Manage Email Alerts
Key takeaways:
- The FDA approved iDose TR for the treatment of open-angle glaucoma and ocular hypertension.
- Commercial launch activities for the implant are anticipated to begin in the first quarter of 2024.
The FDA approved the iDose TR for the lowering of IOP in patients with ocular hypertension or open-angle glaucoma, according to a press release from Glaukos.
“The glaucoma community has struggled with the limitations of topical drug delivery, such as nonadherence and burdensome side effects,” Jay Katz, MD, FACS, chief medical officer at Glaukos, told Healio. “Intracameral placement of iDose TR provides ophthalmologists a long anticipated, welcome option that can be offered to patients which addresses noncompliance and side effect concerns.”
The iDose TR (travoprost intracameral implant) 75 mcg is “designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time” to address issues with patient compliance and side effects caused by topical glaucoma treatments, according to the release.
The implant previously demonstrated positive results in the phase 3 GC-010 and GC-012 trials, which randomized 1,150 patients with open-angle glaucoma or ocular hypertension to treatment with either iDose TR or topical timolol ophthalmic solution, 0.5% twice daily.
At 12 months, 81% of patients treated with iDose TR were free of topical medications across both trials, with 98% of patients continuing in the trial compared with 95% of those treated with timolol. The implant was well tolerated and demonstrated favorable safety results across both phase 3 trials, as well as additional controlled studies, where the most common ocular adverse reactions (2% to 6%) were increases in IOP, iritis, dry eye and visual field defects, “most of which were mild and transient in nature,” according to the release.
Glaukos plans to initiate the commercial launch of iDose TR in the first quarter of 2024.
Editor's note: This article was updated on Dec. 15, 2023, to include comments from the chief medical officer of Glaukos.
Collapse
Read more about
Click Here to Manage Email Alerts