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Glaukos submits IND to study iDose travoprost implant
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Glaukos submitted an investigational new drug application to the FDA for a travoprost intraocular implant with the iDose delivery system, according to a press release.
The system is designed to reduce IOP in patients with glaucoma.
Glaukos is proposing to launch a randomized phase 2 clinical trial to evaluate the safety and early efficacy of two models of the iDose system with different travoprost elution rates. The study will compare travoprost with a 0.5% concentration of timolol maleate ophthalmic solution, according to the release.
The IND includes information on the safety and efficacy of travoprost and data from preclinical testing and an international clinical trial.
In the international trial, 69 patients were randomized to receive one of two models of the implant with different elution rates or topical travoprost. At 12 months, both groups that received the implants had lower mean IOP than those that received topical timolol. Both models of the implant reduced IOP and were well tolerated, the release said.
The iDose system, a titanium implant injected through a clear corneal incision and fixated in the anterior chamber, is designed to elute continuous levels of medication for an extended time. It is capped with a membrane that allows for continuous drug delivery into the anterior chamber. Once depleted, the implant can be removed and replaced.