Safety and Exploratory Efficacy Study of SF0166 in the Treatment of Neovascular Age-Related Macular Degeneration (AMD)

This is a prospective, randomized, double-masked, multicenter, Phase I/II clinical study in
which up to 40 eligible subjects with Neovascular Age-related Macular Degeneration (AMD)will
be randomized to 1 of 2 treatment arms in a 1:1 ratio as follows: SF0166 low dose twice
daily (BID) or SF0166 high dose BID.

The study population includes male and female subjects, aged 50 or older, with active
subfoveal choroidal neovascularization due to Age-related Macular Degeneration (AMD) that
meet the following criteria: ≤12 Macular Photocoagulation Study [MPS] disc areas, with
choroidal neovascularization [CNV] >50% of the total lesion area), retinal or subretinal
fluid visible on optical coherence tomography (OCT), and no treatment with anti-vascular
endothelial growth factor (VEGF) therapy in the study eye within up to 60 days of study
entry.

If a subject qualifies in both eyes, SF0166 may be administered to both eyes (study eye and
non-study eye) at the discretion of the Investigator.

Study subjects will administer the randomly assigned treatment for 28 days. There is an
additional 28-day post-treatment follow-up period. All study subjects will return for
examination every 2 weeks for 8 weeks (2 months).

All outcomes and assessments will be summarized descriptively for Days 0, 14, 28, 42, and
56. No formal hypotheses will be tested.

Inclusion Criteria:

1. Male or female, 50 years of age or older.

2. Active subfoveal choroidal neovascularization due to Age-related Macular Degeneration
(AMD) in the study eye that meet the following criteria:

- Total lesion ≤12 Macular Photocoagulation Study (MPS) disc areas

- Choroidal neovascularization (CNV) >50% of lesion area

- Intraretinal or subretinal fluid due to choroidal neovascularization (CNV)
visible on optical coherence tomography (OCT)

- No atrophy or fibrosis involving the center of the fovea

3. Best-corrected Visual Acuity (BCVA) between 78 and 25 letters, inclusive, in the
study eye at the screening/randomization visit using Early Treatment Diabetic
Retinopathy Study (ETDRS) testing, with BCVA decrement primarily attributable to
neovascular Age-related Macular Degeneration (AMD).

4. Treatment naïve (i.e., no previous anti--vascular endothelial growth factor [VEGF]
treatment in the study eye) or previously treated study eye with adequate washout
defined below:

1. Lucentis (ranibizumab): 30-day washout

2. Avastin (bevacizumab): 30-day washout

3. Eylea (aflibercept): 60-day washout

4. Macugen (pegaptanib): 45-day washout

5. Willing and able to return for all study visits.

6. Able to adhere to the study dosing requirements.

7. Understands and signs the written informed consent form.

Exclusion Criteria:

1. Non-study eye best corrected visual acuity (BCVA) worse than 20 letters at the
screening/randomization visit using Early Treatment Diabetic Retinopathy Study
(ETDRS) testing.

2. Choroidal neovascularization (CNV) in the study eye secondary to other causes (e.g.,
pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal
rupture, posterior uveitis, or multifocal choroiditis).

3. Previous macular laser photocoagulation or ocular photodynamic therapy in the study
eye.

4. Media opacities or abnormalities in the study eye that would preclude visualization
of the retina.

5. Other retinal pathologies in the study eye that would interfere with vision.

6. Retinal pigment epithelial (RPE) tear in the study eye.

7. Significant epiretinal membrane, posterior hyaloidal traction, and/or vitreomacular
traction in the study eye as determined by optical coherence tomography (OCT)
results.

8. Uncontrolled glaucoma or ocular hypertension in the study eye defined as an
Intraocular Pressure (IOP) >25 millimeter of mercury (mmHg) regardless of concomitant
treatment with IOP lowering medications.

9. Uncontrolled hypertension defined as systolic >180 mmHg or >160 mmHg on 2 consecutive
measurements (during the same visit) or diastolic >100 mmHg on optimal medical
regimen

10. Previous pars plana vitrectomy in the study eye.

11. Any intraocular surgery in the study eye within 90 days (3 months) prior to study
enrollment.

12. Yttrium aluminium garnet (YAG) laser treatment in the study eye within 30 days (1
month) prior to study enrollment.

13. Intravitreal/periocular/topical ocular steroids of any type in the study eye within
90 days (3 months) prior to study enrollment.

14. Concomitant use any topical ophthalmic medications in the study eye, including dry
eye or glaucoma medications, unless on a stable dose for at least 90 days (3 months)
prior to study enrollment and expected to stay on stable dose throughout study
participation. Artificial tears are allowed.

15. Chronic or recurrent uveitis in the study eye.

16. Ongoing ocular infection or inflammation in either eye.

17. A history of cataract surgery complicated by vitreous loss in the study eye.

18. Congenital eye malformations in the study eye.

19. A history of penetrating ocular trauma in the study eye.

20. Mentally handicapped.

21. Females of childbearing potential (i.e., who are not postmenopausal for at least 1
year or surgically sterile for at least 6 weeks prior to Visit 1 -
Screening/Randomization) who are lactating, or who are pregnant as determined by a
positive urine pregnancy test (UPT) at Visit 1 - Screening/Randomization. Women of
childbearing potential must agree to use acceptable methods of birth control
throughout the study. Acceptable methods of birth control include tubal ligation,
transdermal patch, intrauterine devices/systems, oral/implantable/injectable or
contraceptives, sexual abstinence, double barrier method, or vasectomized partner.

22. Participation in any other investigational device or drug clinical research study
within 30 days of Visit 1 - Screening/Randomization.

23. Contraindication to the study medications or fluorescein dye.

24. Other ocular pathologies that in the Investigator's opinion would interfere with
vision in the study eye.