Phase I Study of Palomid 529 a Dual TORC1/2 Inhibitor of the PI3K/Akt/mTOR Pathway for Advanced Neovascular Age-Related Macular Degeneration

Inclusion Criteria:

- Best corrected visual acuity in the study eye between 20/100 and 20/800 (between 53
and 4 ETDRS letters read), and better or equal to 20/200 (minimum of 34 letters read)
in the fellow eye.

- Subfoveal choroidal neovascularization (CNV) due to AMD

- Total area of the lesion (including blood, neovascularization and scar/atrophy) must
be < 12 DA.

- Only 1 eye will be treated in the study. If both eyes are eligible, the investigator
will select the eye with the most active CNV

- Clear ocular media and adequate pupillary dilatation to permit good stereo fundus
photography for screening

- Intraocular pressure of 21 mm Hg or less

- Retinal thickness ≥ 250 μm by OCT, with presence of intraretinal or subretinal fluid

Exclusion Criteria:

- Any retinovascular disease or retinal degeneration other than AMD

- Serous pigment epithelial detachment without the presence of neovascularization

- Previous posterior vitrectomy or retinal surgery

- Any periocular infection in the past 4 weeks

- Concomitant therapy with anti-VEGF therapies, e.g. Avastin, Lucentis or Macugen, or
previous use of these agents within 60 days of screening

- Concomitant therapy with intravenous or intravitreous corticosteroids or use within
90 days of screening

- Significant media opacities, including cataract, which might interfere with visual
acuity, assessment of toxicity, or fundus photography

- Cataract surgery in the study eye within 3 months of screening

- Intraocular surgery in the study eye within 3 months of screening

- Presence of ocular infection in the study eye

- Presence of severe myopia (-8 diopters or greater) in the study eye