FDA News

FDA gives greenlight for phase 2 study of travoprost with iDose delivery system

The FDA will allow Glaukos to initiate a U.S. investigational new drug phase 2 study of a travoprost intraocular implant with the iDose delivery system in patients with glaucoma, according to a press release.

“We are very pleased that the FDA is allowing this trial to begin several months in advance of our original target date,” Thomas Burns, president and CEO of Glaukos, said in the release.

The phase 2 study follows the recent investigational new drug submission to the FDA, in which Glaukos proposed conducting a randomized trial to assess the safety and preliminary efficacy of two models of the iDose delivery system with different travoprost elution rates in comparison to timolol maleate ophthalmic solution 0.5%, the release said.

The FDA will allow Glaukos to initiate a U.S. investigational new drug phase 2 study of a travoprost intraocular implant with the iDose delivery system in patients with glaucoma, according to a press release.

“We are very pleased that the FDA is allowing this trial to begin several months in advance of our original target date,” Thomas Burns, president and CEO of Glaukos, said in the release.

The phase 2 study follows the recent investigational new drug submission to the FDA, in which Glaukos proposed conducting a randomized trial to assess the safety and preliminary efficacy of two models of the iDose delivery system with different travoprost elution rates in comparison to timolol maleate ophthalmic solution 0.5%, the release said.