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news.Bayer HealthCare and Regeneron have reported positive two-year results from the Phase III VISTA-DME trial of VEGF Trap-Eye (EYLEA) to treat diabetic macular edema (DME).
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During the trial, EYLEA 2mg dosed monthly and every two months (after 5 initial monthly injections) demonstrated an improvement from baseline in best corrected visual acuity (BCVA) at week 100, compared to laser photocoagulation.
Bayer member of the HealthCare Executive Committee and head of Global Development Jörg Möller said ,"The two-year data confirm the safety and efficacy of VEGF Trap-Eye in treating DME, and we look forward to hopefully offer this new treatment option for DME-patients soon."
After two years, patients receiving EYLEA 2mg dosed monthly had a mean change from baseline in BCVA of 11.5 letters, while patients receiving EYLEA 2mg dosed every two months had a mean change from baseline in BCVA of 11.1 letters.
In addition, patients in the laser photocoagulation treatment group had a mean change from baseline in BCVA of 0.9 letters.
Regeneron chief scientific officer George Yancopoulos said the data showed that treatment with EYLEA in the trial improved vision and maintained the improvement over two years in patients with diabetic macular edema.
"These results are particularly encouraging given that 43 percent of patients in this study had previously received anti-VEGF therapy," Yancopoulos said.
The most frequent ocular adverse events observed in the VISTA-DME trial included conjunctival hemorrhage, eye pain, and vitreous floaters, while the most frequent non-ocular AEs included hypertension, anemia, and urinary tract infection.