Aerie Pharmaceuticals commences Phase 2 clinical trial of AR-1105

By Mateen Dalal

AR-1105 is an intravitreal, fully bio-erodible PRINT-manufactured implant that releases steroid dexamethasone.

Aerie Pharmaceuticals, an ophthalmic pharmaceutical company, has reportedly initiated the Phase 2 clinical trial evaluating AR-1105 for investigation of its dexamethasone intravitreal implant in patients suffering from macular edema caused by retinal vein occlusion (RVO).

Up to 45 patients will be enrolled for this Phase 2 study and trial will be conducted at approximately 20 centers in United States. The primary endpoint of this study is safety, tolerability, and efficacy of AR-1105 dexamethasone intravitreal implant. The estimated date of completion is January 2020.

As per a press release by Aerie Pharmaceuticals, there will be two stages in this study. In first stage, up to 5 patients will be enrolled to receive CF-1 and in stage-2, up to 40 randomized patients will receive either CF-1 or CF-2. CF-2 delivers same dose of dexamethasone for a longer period. This study has been made available at www.clinicaltrials.gov.

Chairman and Chief Executive Officer, Vicente Anido, Jr., Ph.D., cited that they are building a concept study for AR-1105 and retina portfolio based on technology of DSM being developed with bio-erodible polymers and platform of PRINT manufacturing.

He further stated that they are expecting the trial to allow optimization of AR-1105 for achieving their objective in Phase 3 studies. They also have plans to file an investigational new drug, AR-13503 implant, which is a bio-erodible implant delivering Rho kinase/Protein kinase C inhibitor for treating wet-related macular degeneration and diabetic macular edema.

AR-1105 is an intravitreal, fully bio-erodible PRINT-manufactured implant that releases steroid dexamethasone. It is administered by a commonly used in-office treatment called Intravitreal Injection.

For the record, Aerie Pharmaceuticals is a clinical-stage, public pharmaceutical company, concentrated on discovery, development, and commercial aspects of first-in-class therapies for treating patients with eye diseases. Aerie's two lead product candidates are once-daily IOP-lowering therapies with novel mechanisms of action to treat patients with glaucoma or ocular hypertension.