Implant for ocular hypertension, glaucoma gets FDA green light

A travoprost implant (iDose TR, Glaukos) proved noninferior to timolol eye drops, winning FDA approval. “With the next generation of procedural pharmaceutical solutions for glaucoma such as iDose TR, we now have a new tool that will confront the standard legacy practice of relying on topical drops, which are known to cause uncomfortable side effects and present a myriad of challenges such as treatment adherence, complex dosing regimens, and difficulty with self-administration,” John Berdahl, MD, of Vance Thompson Vision, in Sioux Falls, South Dakota, said in the Glaukos statement. “The clinical data suggest that iDose TR is not only effective with a favorable safety profile, but it has potential to relieve patients from the burdens of prescription eye drops for an extended period of time.”

The device contains 75 mcg of travoprost to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension. iDose TR is inserted into a corneal incision on the temple side of the eye. Phase 3 clinical trials showed the treatment resulted in sustained reduction in IOP for three months ranging from 6.6 to 8.4 mm Hg. This is similar to reductions with topical timolol 0.5% drops given twice a day.

Primary support for the FDA approval came from two phase III randomized trials that showed noninferiority versus timolol eye drops. During a presentation at the American Society of Cataract and Refractive Surgery meeting, Berdahl said that 90% of the implant group had well-controlled IOP at 12 months compared with 67% of the timolol group. The device had a favorable safety profile, including low rates of conjunctival hyperemia (makes the white of your eye look red), no corneal endothelial cell loss, and no adverse events of periorbital fat atrophy, a complication associated with some glaucoma eye drops. The implant could be exchanged without evidence of significant endothelial cell loss. According to the company statement, a single administration of the implant has maintained IOP control for as long as 36 months. The company intends to begin sales of the implant during the first quarter of 2024 at an estimated wholesale acquisition cost of $13,950 per implant.

Source:   Charles Bankhead, MedPage Today, December 14, 2023; see source article