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Aerie (AERI) Gets Positive CHMP Opinion for Roclanda in EU

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Aerie Pharmaceuticals, Inc. (AERI - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion recommending approval of the marketing authorization application (MAA) for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%.  Roclanda is recommended by the EMA for the reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient intraocular pressure (IOP) reduction.

The final decision is expected by early 2021 and will be applicable to all European Union member states including Iceland, Norway and Liechtenstein.

In September 2020, Aerie announced successful interim 90-day top-line data from its six-month phase IIIb study in Europe known as Mercury 3, comparing Roclanda to Ganfort. Mercury 3 was designed as a non-inferiority trial to compare IOP reduction in patients with open-angle glaucoma or ocular hypertension. Roclanda met the overall trial objective by demonstrating non-inferiority to Ganfort across nine of nine timepoints over 90 days.

Shares of the company have slumped 46.3% year to date compared with the industry’s decline of 3%.

Roclanda is currently marketed as Rocklatan in the United States. Rocklatan, is a once-daily, quadruple-action, fixed-dose combination of Rhopressa and Xalatan (latanoprost), and is approved to reduce elevated IOP in patients with open-angle glaucoma or ocular hypertension.

Zacks Rank and Stocks to Consider

Aerie currently has a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Cassava Sciences (SAVA - Free Report) , BioLineRx Ltd. (BLRX - Free Report) and Catalent Inc. (CTLT - Free Report) . All stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Cassava’s loss per share estimates have narrowed from 26 cents to 21 cents for 2020 in the past 60 days. Shares of the company have increased 60.9% year to date.

BioLineRx’sloss per share estimates have narrowed from $1.95 to $1.67 for 2020 and from $1.44 to $1.36 for 2021 in the past 60 days. Shares of the company have increased 4.4% year to date.

Catalent’s earnings per share estimates have increased from $2.41 to $2.51 for 2020 and from $2.82 to $2.93 for 2021 in the past 60 days. Shares of the company have decreased 85.8% year to date.

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