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Regeneron's (REGN) Wet AMD Study on High Dose Eylea Meets Goal

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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the phase II proof-of-concept study, which is evaluating an investigational 8 mg dose of its lead drug Eylea (aflibercept) for treating patients with wet age-related macular degeneration (wet AMD), has met the primary safety endpoint.

Data from the study showed that a higher proportion of patients who were treated with 8 mg dose of Eylea injection had no retinal fluid compared to those who received the currently approved 2-mg dose of Eyela at week 16 – the primary efficacy endpoint. There was no new safety signal observed in 8-mg dose of Eylea compared to the approved 2-mg dose of Eyela.

The above-mentioned phase II study investigated the safety, efficacy and tolerability of the 8-mg dose of Eylea compared to the existing approved 2-mg dose of Eyela in treatment-naïve patients with wet AMD.

The 8-mg dose of Eylea is currently being evaluated in two phase III studies in wet AMD and diabetic macular edema (“DME”), with data from the same expected in the second half of 2022. Both  studies are comparing the 8-mg and 2-mg dose of Eyela, testing the dosing intervals at every 12 weeks and 16 weeks.

Shares of Regeneron have rallied 38.6% so far this year compared with the industry’s rise of 1.2%.

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We remind investors that Eylea (2-mg dose) is currently approved in several countries across the world for the treatment of neovascular wet AMD, DME, macular edema following retinal vein occlusion and diabetic retinopathy.

Regeneron has co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . The company is solely responsible for sales of this eye drug and is entitled to profits in the United States. However, it shares profits and losses from the ex-U.S. Eylea sales equally with Bayer, except in Japan where Regeneron receives a royalty on net sales.

Eylea has been a key revenue driver for Regeneron over the years. The drug continues to see strong uptake and demand across geographies. In the first six months of 2021, Eylea generated sales worth $2.8 billion in the United States, reflecting an increase of 21.7% year over year.

A potential label expansion will help Eylea treat a broader patient population and drive sales further in future quarters. However, Eylea faces face stiff competition from Novartis’ (NVS - Free Report) Beovu, which is also approved for the treatment of wet AMD.

Zacks Rank & Key Pick

Regeneron currently carries a Zacks Rank #1 (Strong Buy). Another top-ranked stock in the biotech sector is Horizon Therapeutics Public Limited Company (HZNP - Free Report) , which also has the same Zacks Rank #1 presently. You can see the complete list of today’s Zacks #1 Rank stocks here.

Horizon’s earnings estimates have been revised 23.2% upward for 2021 and 12.7% upward for 2022 over the past 60 days. The stock has surged 48.1% year to date.