Aerie (AERI) Starts Phase II Study On Eye Candidate AR-1105
Zacks Investment Research | Mar 19, 2019 12:28AM ET
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) announced that it has initiated dosing in a phase II study to evaluate its investigational pipeline candidate, AR-1105, for treating patients with macular edema due to retinal vein occlusion (RVO).
The phase II program will enroll up to 45 patients and be conducted at various sites in the United States. The primary endpoint of the study is to examine the safety, tolerability and efficacy of the dexamethasone intravitreal implant, AR-1105. Positive results from this study will help Aerie optimize the formulation of the candidate to achieve the clinical objective in phase III analyses.
AR-1105 is a bio-erodible implant, designed to release the steroid dexamethasone over a six-month period. It is commonly administered through intravitreal injection. The benefits of AR-1105 compared with other steroid products are its six-month duration of efficacy, improved administration owing to a smaller needle size and a better safety profile on the back of lower peak drug levels.
In January 2019, the FDA reviewed the investigational new drug (IND) application for AR-1105.
Apart from AR-1105, Aerie’s retina pipeline includes AR-13503 (rho kinase and protein kinase C inhibitor implant). The IND for AR-13503 is expected to be filed with the FDA in the first quarter of 2019 and if accepted, studies are expected to begin in the second quarter of 2019 for wet age-related macular degeneration and DME (diabetic macular edema).
Shares of Aerie have surged 30.4% so far this year, outperforming the Zacks Investment Research
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