The FINANCIAL -- Top-line results with VEGF Trap-Eye after one year of treatment in the Phase 3 GALILEO study in patients with macular edema due to central retinal vein occlusion confirm the primary endpoint results that were seen after 24 weeks from the two pivotal trials, GALILEO and COPERNICUS.

According to Bayer AG, the results are also in line with previously reported one-year results from the COPERNICUS study. These data are being presented at the World Ophthalmology Congress in Abu Dhabi.

Based on the results of these studies, Regeneron has already submitted a supplemental Biologics License Application in the U.S. and has been granted a FDA action date of September 23, 2012. Bayer HealthCare plans to file a marketing application with regulatory authorities in Europe in the second half of 2012. Regeneron and Bayer HealthCare are collaborating on the global development of VEGF Trap-Eye.

The one-year GALILEO results showed that the proportion of subjects that gained at least 15 letters of vision from baseline to week 52 was 60.2% of patients receiving VEGF Trap-Eye, compared to 32.4% of patients receiving sham injections. In terms of gain in visual acuity from baseline until week 52, patients receiving VEGF Trap-Eye gained, on average, 16.9 letters of vision compared to a mean gain of 3.8 letters for patients receiving sham injections.

The results achieved at week 52 corroborate the previously seen primary and secondary endpoints after 24 weeks, where 60.2 percent of patients receiving monthly VEGF Trap-Eye 2 milligrams gained at least 15 letters of vision from baseline, compared to 22.1 percent of patients receiving sham injections, and patients receiving VEGF Trap-Eye had a mean gain of 18 letters compared to a mean gain of 3.3 letters for patients with sham injections. Patients treated with VEGF Trap-Eye received an average of 2.5 VEGF Trap-Eye injections from week 24 to week 52.

VEGF Trap-Eye was generally well tolerated. The most frequently reported ocular adverse events in the study eye in the VEGF Trap-Eye arm were eye pain, conjunctival hemorrhage, elevated intraocular pressure, macular edema, retinal hemorrhage, reduced visual acuity and retinal vascular disorder.

The most frequently reported adverse events in the sham group were macular edema, retinal hemorrhage, retinal vascular disorder, eye irritation and reduction of visual acuity. 9.6% of patients in the VEGF Trap-Eye arm and 8.8% of patients in the sham arm presented with at least one ocular serious adverse event over the 52 weeks of the trial.

The most frequently reported non-ocular adverse events in the VEGF Trap-Eye arm were back pain, bronchitis, nasopharyngitis, headache, and hypertension. The most frequently reported non-ocular adverse events (>5%) in the sham group were fall, nasopharyngitis, headache, arthralgia, and hypertension.

The one-year COPERNICUS results showed that 55.3% of patients receiving VEGF Trap-Eye dosed monthly for 24 weeks, then on an as-needed basis over the next 28 weeks, gained at least 15 letters on an eye chart compared to 30.1% of patients who received sham injections for the first 24 weeks followed by VEGF Trap-Eye PRN from week 24 to week 52. Patients who went from monthly VEGF Trap-Eye dosing to PRN VEGF Trap-Eye dosing received a mean of 2.7 VEGF Trap-Eye injections, while patients who switched from sham to VEGF Trap-Eye PRN at week 24 received a mean of 3.9 VEGF Trap-Eye injections over 28 weeks.

In terms of gain in visual acuity from baseline to week 52, patients receiving VEGF Trap-Eye gained, on average, 16.2 letters of vision compared to a mean gain of 3.8 letters for patients who switched from sham to VEGF Trap-Eye PRN. At week 24, patients receiving VEGF Trap-Eye had a mean gain of 17.3 letters, while patients receiving sham had a mean loss of 4.0 letters. VEGF Trap-Eye was generally well tolerated.

The most frequently reported ocular adverse events in the study eye in the VEGF Trap-Eye arm were conjunctival hemorrhage, eye pain, maculopathy, elevated intraocular pressure, reduced visual acuity, and vascular disorder of the optic disc. The most frequently reported adverse events in the sham to VEGF Trap-Eye PRN arm were reduced visual acuity, conjunctival hemorrhage, retinal hemorrhage, vitreous hemorrhage, and elevated intraocular pressure.

At week 52, 5.3% of patients receiving VEGF Trap-Eye (monthly to PRN) and 16.2% of patients reported at least one ocular serious adverse event. The most frequently reported non-ocular adverse events in the VEGF Trap-Eye arm were nasopharyngitis, sinusitis, bronchitis, influenza, and hypertension. The most frequently reported non-ocular adverse events in the sham to VEGF Trap-Eye PRN arm were nasopharyngitis, present protein in urine, increased urine protein/creatinine ratio, increased blood glucose, and hypertension.

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