Aerie Pharmaceuticals has begun dosing in a phase 2 clinical trial of AR-1105, its dexamethasone intravitreal implant for patients with macular edema due to retinal vein occlusion.
Forty-five patients will be enrolled in the phase 2 study, which will be conducted at 20 U.S. centers, according to a press release. Safety, tolerability and efficacy of AR-1105 will be evaluated.
“This is a proof of concept study for AR-1105 and for the retina portfolio we are building based on two enabling technologies, the bioerodible polymers we are developing with DSM [Biomedical] and our PRINT manufacturing platform,” Vicente Anido Jr., PhD, chairman and CEO of Aerie, said in the release. “The results of this trial should allow us to optimize the formulation of AR-1105 to achieve this clinical objective in phase 3 studies.”
An initial safety stage of the study will enroll five patients to receive clinical formulation 1, which will deliver a 340-µg dose of dexamethasone in a single intravitreal injection. A second stage of the trial will include 40 patients randomly assigned to receive the first formulation or a second formulation that delivers the same dose of dexamethasone over a longer period, the release said.