August 07, 2013
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Regeneron to speed regulatory submission after positive aflibercept trial results, reports 13.9% increase in quarterly net income

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Following positive 1-year outcomes from two phase 3 trials of aflibercept as a treatment for diabetic macular edema, Regeneron Pharmaceuticals announced it plans to submit an application for U.S. marketing approval this year, approximately 1 year ahead of the previous timeline, according to a company news release.

The company also reported generally accepted accounting principles net income for the quarter ended June 30 of $87.4 million, compared with $76.7 million in the same period last year, for an increase of 13.9%.

The pair of phase 3 randomized, double-masked, active-control trials were designed to analyze the safety and efficacy of Eylea (aflibercept, Regeneron) in patients with diabetic macular edema.

Patients were randomly placed in one of three groups for treatment with 2 mg aflibercept injection monthly, 2 mg aflibercept injection every 2 months or laser photocoagulation.

At the 52-week follow-up in the VIVID-DME trial, monthly injections resulted in best corrected visual acuity improving by 10.5 letters from baseline. Injection every other month after five initial monthly injections resulted in BCVA improvement of 10.7 letters from baseline. Both were significantly better than laser photocoagulation, which resulted in BCVA improvement of 1.2 letters from baseline (P < 0.0001 for both).

After 1 year in the VISTA-DME trial, laser photocoagulation resulted in BCVA improvement of 0.2 letters from baseline. The improvement from monthly injections of aflibercept (12.5 letters) and injections every other months after five initial monthly injections (10.7 letters) were both significantly greater (P < 0.0001 for both).

Both trials will continue to 148 weeks, the release said.

Regeneron’s earnings report noted the company’s revenue for the second quarter was $458 million, up from $304 million in the same period last year. Generally accepted accounting principles net income for the 6 months ended June 30 was $186.3 million, up from $88.4 million in the first 6 months of 2012.