FDA approves of iDose TR (travoprost intracameral implant)

The U.S. Food and Drug Administration has approved iDose TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG), according to a press release.

The FDA has granted approval for the slow-release iDose TR model based on the results of 2 Phase 3 trials involving 1150 patients across 89 clinical sites. These trials compared the iDose TR models, differing in travoprost release rates, with topical timolol ophthalmic solution for open-angle glaucoma or ocular hypertension. Efficacy was demonstrated through a intraocular pressure reduction of 6.6-8.4 mmHg in the iDose TR arm over the first 3 months, affirming non-inferiority to timolol. However, non-inferiority was not maintained over the subsequent 9 months. At 12 months, 81% of iDose TR subjects were medication-free, with excellent tolerability and subject retention. Safety-wise, iDose TR exhibited a favorable profile, with mild and transient adverse reactions reported in 2% to 6% of patients.

Read the full press release here.