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Regeneron Focuses on Expanding Eylea’s Diabetic Retinopathy Label

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Diabetic retinopathy without DME

Regeneron (REGN) plans to submit a supplemental biologics license application (or sBLA) to the FDA seeking approval for Eylea in diabetic retinopathy (or DR) without Diabetic Macular Edema (or DME) in late 2018. DR without DME affects almost 3.5 million people in the United States.

The above diagram shows that 16% of the people suffering from DR are affected by severe nonproliferative diabetic retinopathy (or NPDR), while 13% of DR patients suffer from proliferative diabetic retinopathy (or PDR). 

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Because NPDR and PDR can ultimately result in vision loss for patients, these 1 million patients in the United States present an immediate market opportunity for Eylea. Currently, ~500,000 patients suffering from PDR in the United States are treated with panretinal photocoagulation, also known as laser therapy.

In March 2017, the results of the CLARITY trial were announced. The results demonstrated the superiority of Eylea therapy to laser photocoagulation in terms of visual outcomes in PDR patients.

Eylea’s label expansion in the DR market is expected to enable Regeneron to compete aggressively with other ophthalmic disease players, such as Roche Holdings (RHHBY), Allergan (AGN), and Novartis (NVS).

PANORAMA study

On March 19, Regeneron announced positive top line results from its Phase 3 PANORAMA trial, which aimed to demonstrate the efficacy of Eylea in treating moderately severe to severe NPDR. At the end of 24 weeks, 58% of patients treated with Eylea witnessed two-step or higher improvements compared to the baseline on the DR severity scale, much higher than the 6% of patients receiving sham injections. This trial was the first one involving a therapy that showed the reversal of disease progression in moderately severe to severe NPDR without DME patients. No new safety incidents were noted in this trial.

Regeneron plans to monitor these patients for longer durations to assess whether Eylea is capable of preventing vision-threatening complications.

In the next article, we’ll discuss the launch dynamics of Dupixent in greater detail.

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