Aerie Pharmaceuticals announced the commencement of patient dosing in a phase 2 clinical trial of AR-1105, its investigational dexamethasone intravitreal implant, in patients with macular edema due to retinal vein occlusion (RVO).
This phase 2 study (AR1105-CS201) will be conducted at approximately 20 centers in the United States and enroll up to 45 patients. The primary objectives of the trial are to evaluate the safety, tolerability and efficacy of the AR-1105 dexamethasone intravitreal implant. The study will be conducted in two stages. In the initial safety stage, up to 5 patients will be enrolled in a single cohort to receive clinical formulation #1 (CF-1), delivering a 340µg dose of dexamethasone in a single intravitreal injection. In Stage 2, up to 40 patients will be randomized 1:1 to receive either CF-1 or a second clinical formulation, CF-2, which delivers the same dose of dexamethasone over a longer period. Safety and efficacy will be evaluated at 6 months. More information about the study is available at www.clinicaltrials.gov under the study designation NCT 03739593.
“This is a proof of concept study for AR-1105 and for the retina portfolio we are building based on two enabling technologies, the bio-erodible polymers we are developing with DSM and our PRINT manufacturing platform,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer, said in a company news 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. By the end of this quarter, we also plan to file an investigational new drug (IND) application for our second sustained delivery retina product, AR-13503 Implant, a bio-erodible implant delivering a Rho kinase/Protein kinase C inhibitor for the treatment of wet age-related macular degeneration and diabetic macular edema.”
AR-1105 is a bio-erodible implant that is designed to steadily release the steroid dexamethasone over a 6-month period. It is administered by intravitreal injection, a commonly-used, in-office treatment method. In addition to its 6-month duration of effect, the potential benefits of AR-1105 compared to other intravitreal steroid products include improved administration with a smaller 25G needle and the potential for fewer adverse events due to lower peak drug levels. The market for retinal disease therapeutics in the United States, which is dominated by anti-VEGF agents, was approximately $6 billion in 2018. The intravitreal steroid segment represented approximately $200 million of that total.