Aerie Pharmaceuticals, Inc. 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 industry’s17% rise.
We would like to remind investors that last week, Aerie received the FDA approval for Rocklatan to reduce the elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Rocklatan is a once-daily, quadruple-action fixed-dose combination of Rhopressa (netarsudil) and Pfizer’s PFE Xalatan (latanoprost).
This is the second FDA approval that Aerie has received for treating glaucoma within a year of Rhopressa’s launch in the United States. The company plans to launch Rocklatan in the second quarter of 2019.
Zacks Rank & Other Stocks to Consider
Aerie currently carries a Zacks Rank #2 (Buy). Two other top-ranked stocks in the same sector are Lannett Co Inc LCI and AIT Therapeutics, Inc. AITB, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Lannett’s earnings estimates have moved 1.9% north for 2019 and 2% for 2020 over the past 60 days. The stock has soared 58.8% so far this year.
AIT Therapeutics’ loss per share estimates have been narrowed 18.8% for 2019 and 11.8% for 2020 in the last 60 days. The stock has inched up 1.6% year to date.
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