Bayer to file for EU approval of aflibercept for central retinal vein occlusion

German drug major Bayer (BAY: DE) says that it will file for European approval of its macular edema treatment VEGF Trap-Eye (aflibercept injection) for central retinal vein occlusion in the second half of this year, based on the results of new studies with the drug that were presented at the World Ophthalmology Congress in Abu Dhabi yesterday.

Top-line results with VEGF Trap-Eye (aflibercept injection) after one year of treatment in the Phase III GALILEO study in patients with macular edema due to central retinal vein occlusion (CRVO) confirm the primary endpoint results that were seen after 24 weeks from the two pivotal trials, GALILEO and COPERNICUS. The results are also in line with previously reported one-year results from the COPERNICUS study, the company said

“The results of GALILEO and COPERNICUS are encouraging for patients with central retinal vein occlusion as they show a durable improvement in visual acuity after one year of treatment with VEGF Trap-Eye,” said Kemal Malik, a member of the Bayer HealthCare executive committee and head of global development.