Regeneron Pharmaceuticals, Inc. REGN announced positive two-year results from the phase III PANORAMA study on lead drug Eylea (aflibercept) Injection 2 mg at the Angiogenesis, Exudation, and Degeneration 2020 meeting in Miami, FL.
The study is evaluating Eylea in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).
Eylea is already approved to treat diabetic retinopathy (DR) in the United States.
Data showed that treatment with Eylea reduced the likelihood of vision-threatening events (proliferative diabetic retinopathy or anterior segment neovascularization) by at least 75% at two years. More than half (58%) of the patients in the untreated sham arm developed a vision-threatening complication (VTC) or center-involved diabetic macular edema (CI-DME) within two years of entering the trial, per a Kaplan-Meier analysis.
The two-year results also showed a greater benefit for Eylea patients treated at regular intervals compared to patients who received Eylea treatment less frequently.
These data reinforce that regular Eylea treatment can be highly effective at reducing the risk of new vision-threatening events among patients with moderately severe to severe NPDR.
Adverse events were consistent with the known profile of Eylea.
Regeneron also provided an update on the ongoing studies for high-dose (8 mg) aflibercept. A phase II study (CANDELA) evaluating high-dose aflibercept in wet age-related macular degeneration (wet AMD) is currently enrolling. Moreover, phase III studies planned for 2020 in wet AMD (PULSAR) and DME (PHOTON) will evaluate dosing intervals of 12 weeks or longer.
We note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG BAYRY. The company is solely responsible for sales of this eye drug and 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 the company receives a royalty on net sales.
The PULSAR study is being sponsored by Bayer.
Eylea is currently approved for the treatment of patients with neovascular wet AMD, macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and DR.
Regeneron’s shares have lost 6.6% in the past year compared with the industry’s decline of 1.1%.
However, Eylea is likely to face stiff competition from Novartis AG’s NVS recently approved Beovu.
Regeneron’s recently reported fourth-quarter results were impressive as the company beat on both sales and earnings, driven by the label expansion of Eylea and strong Dupixent sales in moderate-to-severe atopic dermatitis and asthma. Dupixent has been developed in collaboration with Sanofi SNY.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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