Aerie Pharmaceuticals completes enrollment in the Phase 2 Trial its Dexamethasone Intravitreal Implant

DURHAM, N.C.–(BUSINESS WIRE)–Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie), has completed patient enrollment in its Phase 2 clinical trial of AR-1105 in patients with macular edema due to retinal vein occlusion (RVO) is complete several weeks ahead of schedule. AR-1105 is an investigational sustained-release, bio-erodible intravitreal implant containing dexamethasone.

The Phase 2 study (AR-1105-CS201), conducted at 19 centers in the United States, had an enrollment target of 45 patients. The trial is evaluating two formulations of AR-1105 (CF-1 and CF-2) that differ in the duration of dexamethasone release. A few additional patients are currently being screened and, if they are randomized, could bring the total number of patients in the final evaluation to a maximum of 49.

The primary objectives of the trial are to evaluate the safety, tolerability and efficacy of the AR-1105 dexamethasone intravitreal implant. Safety and efficacy will be evaluated at six months. More information about the study is available at www.clinicaltrials.gov under the study designation NCT 03739593.

“We are grateful to our investigators and the patients who have enrolled in this proof-of-concept study for our proprietary sustained-release technology,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer. “We plan to conduct an interim analysis when the first 20 patients have reached the six month timepoint, which should be before the end of this year, making preliminary data available in 2020. The final patient visit should take place in Q2 2020. Meanwhile, our study team will be consulting with regulatory agencies in both the United States and the European Union as they move toward the design of our next trial of AR-1105 in DME.”