FDA Approves Travoprost Intracameral Implant for Glaucoma, Ocular Hypertension

The Food and Drug Administration (FDA) has approved iDose^® TR (travoprost intracameral implant) for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Travoprost, a prostaglandin analog, is a selective FP prostanoid receptor agonist that is believed to reduce IOP by increasing uveoscleral outflow. iDose TR is a sterile intracameral implant containing 75mcg of travoprost. It is designed to continuously deliver the drug inside the eye for extended periods of time.

The safety and efficacy of iDose TR was based on 2 randomized, parallel-group, double-masked, controlled phase 3 trials (ClinicalTrials.gov Identifier: GC-010 [NCT03519386], GC–012 [NCT03868124]) in adult patients with open-angle glaucoma or ocular hypertension. Study participants were randomly assigned to receive either iDose TR containing travoprost 75mcg with different release rates or timolol maleate ophthalmic solution 0.5% twice daily. The primary endpoint for both studies was the change from baseline in diurnal IOP (as measured at 8am and 10am) over 3 months (day 10, week 6, and month 3).

Findings showed that treatment with iDose TR demonstrated an IOP reduction of 6.6 to 8.4mmHg over the first 3 months compared with an IOP reduction of 6.5 to 7.7mmHg in the timolol arm. iDose TR was found to be noninferior to timolol in IOP reduction over the first 3 months, but did not demonstrate noninferiority over the following 9 months. Across both trials, 81% of patients who received iDose TR were completely free of IOP-lowering topical medications.

The most common ocular adverse reactions reported with iDose TR were increased IOP, iritis, dry eye, and visual field defects. The prescribing information for iDose TR includes warnings and precautions associated with iridocorneal angles, device dislocation, macular edema, intraocular inflammation, pigmentation, and endophthalmitis. The product is contraindicated in patients with active or suspected ocular or periocular infections, corneal endothelial cell dystrophy, prior corneal transplantation or endothelial cell transplants.

iDose TR is pre-loaded in a sterile, single-dose inserter. Treatment is administered intracamerally through a small, clear corneal incision and is anchored into the sclera at the iridocorneal angle. iDose TR should not be readministered to an eye that received a prior iDose TR.

The product is expected to be available in the first quarter of 2024.