麻豆传媒

The FDA approved the travoprost intracameral implant (iDose TR) for treatment of ocular hypertension and glaucoma, device developer Glaukos announced on Thursday.

The implant is designed to provide long-duration treatment for the "full range of glaucoma disease severity," according to a from the company. The implant releases the prostaglandin analog travoprost, which is already approved for the two ocular conditions.

"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," said John Berdahl, MD, of Vance Thompson Vision, in Sioux Falls, South Dakota, 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."

Primary support for the approval came from two phase III randomized trials that demonstrated noninferiority versus timolol eye drops. Patients randomized to the implant had a decrease in intraocular pressure (IOP) from baseline (mean 24 mm Hg) to 90 days: by 6.6-8.5 mm Hg in one trial and 6.7-8.4 mm Hg in the second. The timolol eye drops achieved reductions of 6.6-7.7 mm Hg and 6.8-7.2 mm Hg in the trials.

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 as compared with 67% of the timolol group. The device had a favorable safety profile, including low rates of conjunctival hyperemia, no corneal endothelial cell loss, no serious corneal adverse events, and no adverse events of periorbital fat atrophy. 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.

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