Bayer HealthCare and its partner Regeneron Pharmaceuticals have reported promising results from late- and mid-stage clinical trials with their experimental eye drug VEGF Trap-Eye (aflibercept ophthalmic solution) in macular oedema.

Also in clinical development for age-related macular degeneration (AMD) and other eye disorders, VEGF Trap-Eye is regarded as a key component of Bayer’s advanced pipeline, with peak sales projected at between 250 million and 500 million euros.

The new data include top-line results from the COPERNICUS study, led by Regeneron and the first of two Phase III trials of VEGF Trap-Eye in patients with macular oedema due to central retinal vein occlusion.

In this setting, 56.1% of patients receiving VEGF Trap-Eye 2mg on a monthly basis gained at least 15 letters of vision from baseline, compared with 12.3% of patients receiving sham injections, Bayer and Regeneron said.

This was the primary study endpoint. On a secondary endpoint, patients given VEGF Trap-Eye 2mg monthly gained, on average, 17.3 letters of vision compared with a mean loss of 4.0 letters on sham injections. The second Phase III trial, GALILEO, is led by Bayer HealthCare and is ongoing.

“If these results are confirmed by data from the GALILEO study, expected in the second quarter of 2011, VEGF Trap-Eye could provide patients and physicians with a new treatment option for central retinal vein occlusion,” commented Dr George Yancopoulos, president of Regeneron Research Laboratories.

A total of 114 patients were randomised to receive VEGF Trap-Eye and 73 to the control arm. Serious ocular adverse events in the VEGF Trap-Eye group were uncommon (3.5% of the total) and were more frequent in the control group (13.5%), Bayer and Regeneron noted.

As the COPERNICUS trial met its primary endpoint, Regeneron will receive a US$10 million milestone payment from Bayer HealthCare. This is in addition to the US$10 million milestone payment already made this month for positive results in the VIEW 1 and VIEW 2 trials of VEGF Trap-Eye for wet AMD.


The two companies also reported 52-week follow-up results from the Phase II DA VINCI study of VEGF Trap-Eye in patients with diabetic macular oedema.

The previously reported visual acuity gains achieved with VEGF Trap-Eye over 24 weeks (the study’s primary endpoint) were maintained or numerically improved up to completion in all VEGF Trap-Eye groups, including 2mg dosing every other month, Bayer and Regeneron said.

Based on these outcomes, the companies are discussing plans to launch Phase III trials with VEGF Trap-Eye in diabetic macular oedema.

Last month the development partners announced top-line results from the Phase III VIEW 1 and VIEW 2 trials of VEGF Trap-Eye in wet AMD, showing the drug was as effective as Roche’s and Novartis’ blockbuster Lucentis for this indication.

“We are working diligently with Regeneron to prepare regulatory filings for VEGF Trap-Eye in wet AMD to submit in the first half of 2011,” noted Dr Kemal Malik, head of global development for Bayer HealthCare.