Anti-VEGF formulation reduced retinal thickness, improved vision in phase 2 AMD study

TARRYTOWN, N.Y. — VEGF Trap-Eye reduced retinal thickness and improved visual acuity in a phase 2 trial involving patients with exudative age-related macular degeneration, Regeneron Pharmaceuticals announced in a press release.

Regeneron is developing VEGF Trap-Eye with Bayer HealthCare. The phase 2 trial included 157 patients with wet AMD randomly assigned to one of five study groups. Two groups received monthly doses of 0.5 mg or 2 mg of VEGF Trap-Eye in one eye for 12 weeks. The other three groups received quarterly doses of 0.5 mg, 2 mg or 4 mg of the drug in one eye at baseline and at 12 weeks follow-up, according to the release.

In all groups combined, the mean retinal thickness had decreased by 119 µm at 12 weeks follow-up (P < .0001). Visual acuity had also improved by an average of 5.7 letters (P < .0001), the release said.

Additionally, preliminary results for 16 weeks follow-up indicated that retinal thickness and visual acuity in all groups combined continued to improve. At 16 weeks, retinal thickness had decreased an average of 159 µm and visual acuity had increased an average of 6.6 letters compared with baseline (P < .0001).

However, patients receiving monthly doses showed better improvements than those treated quarterly. Among patients treated monthly, retinal thickness decreased an average of 160 µm in the 0.5 mg group and an average of 183 µm in the 2 mg group. Visual acuity improved an average of 9.3 letters in the 0.5 mg group and an average of 10 letters in the 2 mg group, according to the release.

The quarterly dosing improved retinal thickness and visual acuity at 12 and 16 weeks follow-up compared with baseline, but the effect was not as robust as with monthly dosing. A single 2 mg dose maintained a similar effect on visual acuity as monthly treatment with the 2 mg dose at 8 weeks follow-up, with eyes treated quarterly having mean visual acuity gain of 5.8 letter vs. 6.2 letters gained for monthly-treated patients.

"These results reaffirm the decision to study both the 0.5 mg and 2 mg monthly doses in the phase 3 program," said Jeffrey Heier, MD, a primary investigator in the phase 2 study and chair of the steering committee for the phase 3 VIEW 1 trial, in the release.

"The quarterly dosing arms seemed to sustain their effect on visual acuity out to 8 weeks, providing the rationale for exploring an 8-week dosing schedule in the phase 3 program. Further improvement in visual acuity and dosing convenience continue to represent major unmet medical needs in the treatment of wet AMD," he said.

Regeneron and Bayer HealthCare initiated a phase 3 development program for VEGF Trap-Eye in wet AMD in August. The first phase 3 trial is currently enrolling patients and will evaluate 4-week and 8-week dosing intervals of VEGF Trap-Eye in direct comparison with Lucentis (ranibizumab, Genentech) administered every 4 weeks.