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Regeneron Eylea Hits 24-Week Primary Endpoint in Study

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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced positive topline results from the phase III study evaluating Eylea (aflibercept) Injection in moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME), compared with sham injection.

The PANORAMA study met its 24-week primary endpoint -- the proportion of patients who experience a two-step or greater improvement in Diabetic Retinopathy Severity Scale (DRSS) score from baseline. In the study, 58% of patients who were treated with Eylea achieved a two-step or greater improvement in DRSS score from baselineat week 24, compared to 6% of patients receiving sham injection.

This is the first study in which an eye treatment has demonstrated reverse disease progression in the above mentioned patient population. The patients are continued to be studied to see if treatment with Eylea can prevent progression to neovascular vision-threatening complications or DME.

Another primary endpoint of the study is the proportion of patients who experience a two-step or greater improvement in DRSS score from baseline at 52 weeks. The 52 week data is expected to be presented later this year.

Results from the PANORAMA study will be submitted for presentation at a future medical congress. The 24-Week results from the study will also form the basis of a supplemental Biologics License Application (sBLA) to the FDA later in 2018.

The company is also conducting another study -Protocol W which is evaluating Eylea for the treatment of NPDR in patients without diabetic macular edema (DME).

Over a year, shares of the company have declined 8.2% against the industry’s gain of 8.1%.

We note that Eylea  is approved in the United States, the EU, Japan and other countries for the treatment of neovascular age-related macular degeneration (wet AMD), DME, macular edema following retinal vein occlusion, which includes macular edema following central retinal vein occlusion and macular edema following branch retinal vein occlusion.

Label expansion into additional indications would give Eylea access to higher patient population and increase the commercial potential of the drug.

Eylea sales increased 19% year over year to $1,612 million in 2017.

Meanwhile, Novartis (NVS - Free Report) is developing brolucizumab for treating neovascular (wet) AMD. The candidate in November 2017, demonstrated non-inferiority to Eylea in phase III studies for long-lasting effects in patients. Moreover, it has shown superior improvement in reductions in retinal thickness due to fluid accumulation versus Eylea. A potential approval of brolucizumab will hurt Regeneron’s product sales.

Ophthotech Corp. (OPHT - Free Report) is also developing its pipeline candidate, Zimura, in a phase IIa study for treating wet AMD with data expected late in 2018.

Zacks Rank & Key Pick

Regeneronholds a Zacks Rank #2 (Buy). Another better-ranked stock from the same space is Ligand Pharmaceuticals (LGND - Free Report) sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Ligand’s earnings per share estimates have moved up from $3.78 to $4.20 and from $4.75 to $5.32 for 2018 and 2019, respectively over the last 30 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 24.88%. The company’s shares have rallied 66.8% over a year.

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