Glaukos Launches Implantable Glaucoma Treatment

Glaukos has launched iDose TR (travoprost intracameral implant) to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. The FDA approved iDose TR in December 2023. It has a wholesale acquisition cost of $13,950 per dose/implant. The company provides copay and financial assistance for qualifying patients. For every iDose TR sold, the company will make one available for donation, executives said during an investor call in December.

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 therapy uses Celanese’s VitalDose EVA delivery technology to provide sustained drug release.

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.

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 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.