A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy

Subjects will be randomized in a 1:1 ratio to the following dose groups:

- Fovista® 1.5 mg/eye + Lucentis® 0.5 mg/eye

- Fovista® sham + Lucentis® 0.5 mg/eye

Subjects will be treated for a total of 24 months with active Fovista® or sham in combination
with Lucentis® with the primary endpoint at 12 months.

Primary Efficacy Endpoint:

The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from
baseline at the month 12 visit.

Safety Endpoints:

Safety endpoints include adverse events, vital signs, ophthalmic variables [ophthalmic
examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence
tomography (OCT)], ECG, and laboratory variables.

Approximately 622 subjects will be randomized into one of the two treatment cohorts (311
patients per dose group).

Inclusion Criteria:

- Subjects of either gender aged ≥ 50 years

- Active subfoveal choroidal neovascularization (CNV) secondary to AMD

- Presence of sub-retinal hyper-reflective material (SD-OCT)

Exclusion Criteria:

- Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral
supplements of vitamins and minerals

- Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless
of indication (including intravitreal corticosteroids)

- Any intraocular surgery or thermal laser within three (3) months of trial entry. Any
prior thermal laser in the macular region, regardless of indication

- Subjects with subfoveal scar or subfoveal atrophy are excluded

- Diabetes mellitus