Aerie Pharmaceuticals, Inc. ( AERI Quick Quote AERI - Free Report) announced data from the phase IIb study (“COMET-1”), which evaluated its investigational therapy, AR-15512, in patients with dry eye disease. While the study achieved statistical significance over multiple pre-specified symptom and sign endpoints, it did not achieve all pre-determined primary endpoints with statistical significance.
Shares of the company declined 17.8% in the after-market trading session on Sep 15, following mixed results of the study. In the year so far, Aerie’s stock price has risen 16.2% against the
industry’s 12.1% decline. Image Source: Zacks Investment Research COMET-1 evaluated the efficacy and safety of AR-15512 in 369 patients with dry eye disease over an 84-day treatment period. The study randomized the patients into three arms — two concentrations of AR-15512 (0.0014% and 0.003%) and AR-15512 vehicle — dosed twice daily.
The company evaluated the participants of the study at four different intervals - days 1, 14, 28 and 84. The data from the study demonstrated that AR-15512 significantly improved both symptoms and signs from day 14 of the study, with continuous improvement throughout the treatment period.
Yet, the study did not meet the predetermined primary endpoints with statistical significance at day 28. Per the company, AR-15512 will advance to phase III studies as the selection of primary endpoints is not required in a phase IIb study.
While both the concentrations of AR-15512 were safe and well-tolerated among patients, data from the study demonstrated that 0.003% concentration achieved greater efficacy than 0.0014% concentration. The company will advance 0.003% concentration in phase III studies.
It plans to initiate two phase III efficacy studies and a safety study in second-quarter 2022. Before the commencement of the studies, the company will hold an end-of-phase II meeting with the FDA in first-quarter 2022.
We remind investors that following the acquisition of Spanish ophthalmic company Avizorex Pharma in 2019, Aerie acquired Avizorex’s lead drug AR-15512, a TRPM8 agonist ophthalmic solution designed to treat dry-eye disease. Per an SEC filing, Aerie anticipates filing a new drug application in the United States for AR-15512 in the first half of 2024.
Zacks Rank & Stocks to Consider
Aerie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech/drug sector include
Horizon Therapeutics ( HZNP Quick Quote HZNP - Free Report) , Ironwood Pharmaceuticals ( IRWD Quick Quote IRWD - Free Report) and Regeneron Pharmaceuticals ( REGN Quick Quote REGN - Free Report) , each carrying a Zacks Rank #1 (Strong Buy) at present. You can see . the complete list of today’s Zacks #1 Rank stocks here
Horizon’s earnings per share estimates for 2021 have increased from $3.62 to $4.61 in the past 60 days. The same for 2022 has risen from $5.18 to $6.08 over the same period. The stock has rallied 45% in the year so far.
Ironwood’s earnings per share estimates for 2021 have increased from $1.00 to $1.18 in the past 60 days. The same for 2022 has risen from $1.18 to $1.72 over the same period. The stock has rallied 6.2% in the year so far.
Regeneron’s earnings per share estimates for 2021 have increased from $50.00 to $53.22 in the past 60 days. The same for 2022 has risen from $40.91 to $44.84 over the same period. The stock has rallied 35% in the year so far.