Aerie Pharmaceuticals (AERI - Free Report) announced that the FDA has accepted the investigational new drug application (IND) for AR-15512 eye drop for dry eye disease.
With the acceptance of the IND, the company can now initiate clinical studies on AR-15512 for the treatment of dry eye disease. It expects to initiate a phase IIb study in the fourth quarter of 2020.
Shares of the company have plunged 52.7% year to date compared with the industry’s decline of 8.3%.
AR-15512, a TRPM8 agonist formerly known as AVX-012, was acquired by Aerie in November 2019 with the acquisition of Spanish ophthalmic drugmaker, Avizorex Pharma.
The acceptance of the IND for AR-15512 indicates that it is the first dry eye pipeline product ofAerie, which isan important milestone for the company. The company expects to begin a phase IIb study, followed by a phase III study, later in 2020, with a top-line readout expected in the third quarter of 2021.
There are several companies developing products for the treatment of dry eye disease. Aurinia Pharmaceuticals Inc. (AUPH - Free Report) is evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome. AbbVie’s (ABBV - Free Report) Restasis (added to the portfolio with the acquisition of Allergan) is already marketedfor the treatment of dry eye disease. However, Restasis has several patents that are set to expire in 2024.
Aerie’s retina programs on AR-13503, anrho kinase and protein kinase C inhibitor implant, and AR-1105, adexamethasone steroid implant, continue to advance as well. The IND for AR-13503 has been accepted by the FDA.It is currently in phase I study in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).
Zacks Rank & Stocks to Consider
Aerie currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the healthcare sector includes Emergent Biosolutions Inc. (EBS - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have increased from $5.31 to $6.58 for 2020 and from $6.06 to $7.62 for 2021 over the past 60 days. Shares of the company have increased 93.4% year to date.
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