Bayer and Regeneron plan to test drug against Lucentis

Bayer Healthcare, a subsidiary of Bayer AG, and US biotech partner Regeneron Pharmaceuticals have launched a clinical trial to try and demonstrate that their VEGF Trap-Eye drug is on a par with Genentech's Lucentis (ranibizumab).

Regeneron and Bayer HealthCare are collaborating on the global development of the VEGF Trap-Eye for the treatment of wet-age-related macular degeneration (wet-AMD), diabetic eye diseases, and other eye diseases and disorders.

Bayer HealthCare plans to market the VEGF Trap-Eye outside the US, where the parties will share equally in profits from any future sales of the VEGF Trap-Eye. Regeneron maintains exclusive rights to the VEGF Trap-Eye in the United States.

Bayer and Regeneron will undertake the proposed non-inferiority comparison Phase III study on 1,200 patients with wet-AMD - the leading cause of blindness for people over the age of 65 in the US and Europe.

VEGF Trap-Eye and Lucentis work in similar ways to stop the abnormal growth of new blood vessels, which causes wet AMD. The non-inferiority comparison of the VEGF Trap-Eye and Lucentis will be conducted following a Special Protocol Assessment from the US Food and Drug Administration (FDA).

The trial
The trial, known as VIEW 1 (VEGF Trap: Investigation of Efficacy and safety in Wet age-related macular degeneration), is the first study in the companies' Phase III global development programme in wet AMD, to be carried out in the US, Europe, and other parts of the world.

The randomised, double-masked Phase III study aims to evaluate the safety and efficacy of the VEGF Trap-Eye at doses of 0.5 mg and 2.0 mg administered at four-week dosing intervals and 2.0 mg at an eight-week dosing interval, compared to 0.5 mg of Lucentis administered every four weeks, consistent with its labelled dosing schedule.

The primary endpoint of the study is the proportion of patients treated with the VEGF Trap-Eye who maintain or improve vision at the end of one year, compared to ranibizumab patients. Visual acuity is defined as the total number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Maintenance of vision is defined as losing fewer than three lines (equivalent to 15 letters) on the ETDRS chart. After the first year of treatment, patients will continue to be treated and followed for another year.

In an analysis of interim data from the ongoing Phase 2 trial in wet AMD, where patients were treated with the VEGF Trap-Eye either monthly or quarterly, combined data for all patients demonstrated a statistically significant reduction in retinal thickness and improvement in visual acuity after 12 weeks, compared to baseline.

There were no drug-related serious adverse events, and treatment with the VEGF Trap-Eye was generally well-tolerated. The most common adverse events were those typically associated with intravitreal injections. The interim results of this Phase 2 trial were presented at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) this past May. The companies expect to report final primary endpoint results of the trial at a scientific meeting later this quarter.

"The initiation of this Phase III trial represents a major milestone in the development of the VEGF Trap-Eye to treat wet AMD," said Avner Ingerman, MD, vice president and ophthalmology team leader for Regeneron. "While this trial enables us to continue in our effort to improve the lives of patients suffering from wet AMD, it also signals the beginning of a larger, more global development programme investigating the potential of VEGF Trap-Eye for the treatment of diabetic eye diseases and other eye diseases and disorders."