NT-101 Topical Ophthalmic Solution in Patients With Wet AMD

Inclusion Criteria:

1. Subject who is male or female ≥ 50 years of age at Screening.

2. Choroidal neovascularization (CNV) lesions secondary to AMD that affected thecentral subfield in the study eye that meets the following criteria at Screening:

• Total area of CNV (including both classical and occult) comprising > 50% of thetotal lesion area on FA

• Leakage covering > 50% of the total lesion area on FA

• Intraretinal and/or subretinal fluid affecting the central subfield visible onOCT. If fluid is not visible due to previous treatment, earlier documented OCT imagesshowing fluid for diagnosing wet AMD can be reviewed to fulfill this criterion.

• No atrophy or fibrosis involving the center of the fovea.

3. BCVA between 25 and 78 letters, inclusive, in the study eye at Screening using ETDRStesting, with BCVA decrement primarily attributable to wet AMD.

4. Either no previous treatment in the study eye with anti-VEGF therapy (treatmentnaïve) or previously treated study eye with adequate washout from the baseline visitas defined below:

• Lucentis (ranibizumab): 30-day washout

• Avastin (bevacizumab): 30-day washout

• Eylea (aflibercept): 60-day washout

• Eylea (aflibercept) high dose 8mg: 90-day washout

• Vabysmo (faricimab-svoa): 90-day washout

• Biosimilars

• Byooviz (ranibizumab-nuna): 30-day washout

• Cimerli (ranibizumab-eqrn): 30-day washout

5. Demonstrate the ability to instill eye drops (by the subject or caregiver) in thestudy eye, express willingness to comply with the dosing regimen, and commit toattending all study visits.

6. Understands and voluntarily signs an informed consent form.

7. Female participants of childbearing potential and male participants able to fatherchildren must have (or have a partner who has) had a hysterectomy or vasectomy, becompletely abstinent from intercourse, or agree to practice two acceptable methodsof contraception throughout the course of the study and 3 months after their laststudy administration. Acceptable methods of contraception include :

• hormonal contraception (i.e., birth control pills, injected hormones, dermalpatch, or vaginal ring),

• intrauterine device,

• barrier methods (diaphragm, condom) with spermicide, or

• surgical sterilization (hysterectomy or tubal ligation).

Exclusion Criteria:

1. Subject who has the following illness or abnormal laboratory test values at Screening:

• Uncontrolled hypertension (systolic > 180 mmHg or diastolic > 100 mmHg) despiteoptimal medical regimen

• Uncontrolled diabetes (HbA1c > 12.0%)

• Total bilirubin > 1.5 × Upper Limit of Normal (ULN)

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN

• Prothrombin time (PT) > 1.5 x ULN

• Hemoglobin (Hb) < 10 g/dL (male); Hb < 9 g/dL (female)

• Platelets < 100 x 103/μL

• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2

• Positive results for Human Immunodeficiency Virus (HIV) or Hepatitis B or Cviruses

2. Other clinically significant abnormal lab values per Investigator's judgement.

3. Subject who has a medical condition that, in the opinion of the Investigator, wouldpreclude participation in the study (e.g., unstable medical status includingpsychiatric disorder, cardiovascular disease, poor glycemic control, and significantmedical condition including end-stage renal disease and severe liver diseases).

4. History of stroke or myocardial infarction within 6 months prior to Screening.

5. Subject who has had major surgery within 3 months prior to Screening.

6. Pregnant or breastfeeding or intended to become pregnant during the study.

7. Subject with known hypersensitivity to any active substance or excipients of theinvestigational product, fluorescein, dilating eye drops, or any of the anestheticand antimicrobial drops.

8. Treatment with investigational therapy or participation in any other type ofinterventional trial within 30 days before Screening.

9. Subject who has a history of AMD treatment in the study eye with Beovu® (brolucizumab) or photodynamic therapy.

10. CNV in the study eye secondary to other causes or subject who has an ocularcondition (other than AMD) that, in the opinion of the Investigator, may limitvisual acuity improvement during the course of the study (e.g., ocularhistoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture,multifocal choroiditis, congenital eye malformations, retinal pigment epithelialtear, or posterior uveitis etc.)

11. Media opacities or abnormalities in the study eye that would preclude visualizationof the retina.

12. Subject who has a history of retinal detachment or retinal detachment repair surgeryin the study eye.

13. Subject who has a history of yttrium aluminum garnet (YAG) capsulotomy performedwithin 2 months prior to randomization in the study eye.

14. Uncontrolled glaucoma in either eye (IOP > 25 mmHg despite treatment with a standardregimen of antiglaucoma medications), with exceptions allowed at the Investigator'sdiscretion.

15. Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectiousblepharitis, uveitis) in either eye on Screening.

16. Subject who has a history of vitrectomy in the study eye.

17. Subject who has a history of ocular surgery in the study eye (including cataractextraction, any intraocular surgery, etc.) within 3 months prior to Screening oranticipated within the next 6 months following randomization.

18. Subject who has any history of intraocular inflammation in either eye other thanwhat would be expected in the normal post-operative course following prior routineocular surgery such as cataract surgery.

19. Subject who has other retinal pathologies in the study eye that would interfere withvision, such as evidence of diabetic macular edema or diabetic retinopathy (definedas more than one microaneurysm).

20. Non-study eye with a BCVA worse than 20 letters at Screening using ETDRS testing.