FDA Approves Implantable Glaucoma Treatment

The FDA has approved Glaukos’ iDose TR (travoprost intracameral implant) to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. It will be available in first quarter of 2024 with a wholesale acquisition cost of $13,950 per dose/implant.

Glaucoma is a group of conditions that damage the optic nerve. Open angle glaucoma is a progressive condition that is characterized by raised intraocular pressure and a normal anterior chamber angle (part of the eye located between the cornea and the iris). Compliance is a challenge for patients taking topical medications for glaucoma. In one study, 50% of patients were noncompliant and another 35% administered the medication improperly.

iDose TR is long-duration therapy that is implanted in the anterior chamber. This enables a preservative-free formulation of travoprost to be continuously delivered to the inside the eye for up to three years.

The company also to provide copay and financial assistance for qualifying patients. For every iDose TR sold, the company will make one available for donation, Joe Gillam, president and chief operating officer, said during an investor call.

The FDA approval is based on results from two phase 3 pivotal trials that enrolled 1,150 patients and compared the safety and efficacy of a single administration of one of two iDose TR models with different travoprost release rates to topical timolol ophthalmic solution, 0.5% twice a day.

Both phase 3 trials achieved the primary efficacy endpoints through three months and demonstrated a favorable tolerability and safety profile through 12 months. The trials found that iDose TR was non-inferiority to timolol ophthalmic solution in reducing intraocular pressure reduction during the first three months.

But regulators also noted that subsequently iDose TR did not demonstrate non-inferiority over the next nine months. In an investor call, Tom Burns, chairman and CEO, said the company only powered the study to assess non-inferiority over three months. At 12 months in both trials, 81% of iDose TR subjects were completely free of topical medications that lowered intraocular pressure. He noted that repeat administration has not be approved. Burns said they are working with the FDA on a path forward for repeat administrations, while also advancing the next generation version, a high-dose extended release, into late-stage trials.

The most common ocular adverse reactions reported iDose TR patients were increases in intraocular pressure, iritis, dry eye, and visual field defects, most of which were mild and transient in nature. In the trials, 98% of patients continued with the trial for 12 months.

Long term results of a phase 2b study were recently published in the Dec. 7, 2023, issue of Drugs in which iDose TR was found to lower the burden of topical medications for up to 36 months. In the trial 69% of patients treated with iDose were well controlled at 36 months.