Aerie Pharmaceuticals, Inc. (AERI - Free Report) announced that the FDA has reviewed the Investigational New Drug (IND) application for AR-1105 (dexamethasone intravitreal implant). The company will now initiate studies for AR-1105 for the treatment of macular edema due to retinal vein occlusion (RVO). Aerie plans to begin a phase II study later in the first quarter of 2019.
Shares of Aerie have declined 26% in the past year compared with the industry’s decline of 19.6%.
AR-1105 is a bio-erodible implant that is designed to release the steroid dexamethasone over a six-month sustained period. It is commonly administered through intravitreal injection. The benefits of AR-1105 versus other steroid products are its six-month duration of efficacy, improved administration owing to a smaller needle size and a better safety profile due to lower peak drug levels.
AR-1105 is the first IND stage candidate in Aerie’s retina pipeline. The company also plans to file an IND for its second retina product for the treatment of wet age-related macular degeneration and diabetic macular edema.
The advancements of these candidates will make Aerie reach its goal of being the next major ophthalmic pharmaceutical company.
We remind investors that another company Regeneron’s (REGN - Free Report) drug Eylea, which is co-developed by HealthCare unit of Bayer AG (BAYRY - Free Report) , is approved in the United States, EU, Japan and other countries for the treatment of wet AMD, diabetic macular edema (DME), macular edema following retinal vein occlusion, which includes macular edema following central retinal vein occlusion and macular edema following branch retinal vein occlusion.
Zacks Rank and A Stock to Consider
Aerie currently carries a Zacks Rank #4 (Sell).
A better-ranked stock from the same space is Merck & Co., Inc. (MRK - Free Report) , which holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Merck’s earnings per share estimates have increased from $4.28 to $4.33 for 2018 and from $4.65 to $4.69 for 2019 over the past 90 days. The company delivered a positive earnings surprise in all the trailing four quarters, with the average being 3.96%.
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