- A combination therapy pairing Regeneron Pharmaceutical's blockbuster eye drug Eylea with an experimental antibody failed to improve visual acuity and resulted in a higher occurrence of ocular side effects compared to treatment with Eylea alone, the Tarrytown, NY-based biopharma reported Friday.
- Regeneron is testing the combo in patients with neovascular age-related macular degeneration (wet AMD). Adding rinucumab to Eylea (aflibercept) led to a 5.8 letter improvement in best corrected visual acuity, well below the 7.5 letter improvement seen with Eylea monotherapy.
- Eylea is a big seller for Regeneron, raking in $1.6 billion in U.S. sales over the first half of the year. Regeneron shares fell by over 3% in Friday morning trading on news of the trial setback to trade near $402 apiece.
While the company has a number of other pipeline candidates in advanced studies, Eylea accounts for the bulk of its sales and Regeneron has been working to bolster its position in the ocular treatment market.
Not only did the combo fail to improve on Eylea's efficacy, treatment with the two drugs led to a higher level of ocular adverse events. At 12 weeks, 23.5% and 20% of patients in the two combo treatment arms experienced adverse events, compared to 16% treated with Eylea monotherapy.
Regeneron is continuing the Phase 2 trial, which re-randomized patients in two of the three cohorts at 12 weeks for the second part of the study. Data will be re-evaluated at 28 weeks and again at 52 weeks.
Eylea is also being tested in another Phase 2 study pairing the drug with nesvacumab for treatment of wet AMD.
"We are committed to continuing to innovate for patients with serious vision-threatening diseases, and look forward to the results of our ongoing combination studies of aflibercept and nesvacumab, an anti-angiopoietin 2 antibody, for which the preclinical data is more supportive," Regeneron Chief Scientific Officer George Yancopoulos said.
Outside of Eylea, Regeneron is partnered with Sanofi on several drugs, including the already approved high cholesterol treatment Praluent.
Two other compounds, sarilumab and dupilumab, are being tested in ongoing Phase 3 studies for rheumatoid arthritis and atopic dermatitis, respectively.