Safety Tolerability and Efficacy of Intravitreal LMG324 in the Treatment of Neovascular Age-Related Macular Degeneration

Inclusion Criteria:

• Must give written informed consent, be able to make the required study visits and follow instructions.
• Best corrected visual acuity (BCVA) of 34 letters (approximately 20/200 Snellen or better) in the non-study eye.

SAD population only:

• Subject's study eye must have a choroidal neovascularization (CNV) lesion due to age-related macular degeneration (AMD), either treatment naïve or previously treated, that can be expected to benefit, in the opinion of the investigator, from anti-vascular endothelial growth factor (anti-VEGF) therapy.
• Previously treated eyes must have a history of least 3 administrations of any intravitreal (IVT) anti-VEGF therapeutic for the treatment of CNV with the last injection administered ≥ 1 month prior to the planned administration of the study drug.

Enrollment expansion population only

• Subject's study eye must have untreated and active CNV lesion due to AMD.
• BCVA, between 73 - 23 letters, inclusive (approximate Snellen equivalent 20/40 - 20/320) in the study eye.

Exclusion Criteria:

SAD and enrollment expansion population

• Both eyes: any active ocular or periocular infection or active intraocular inflammation (eg, infectious blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis).
• Study eye: current vitreous hemorrhage or a history of rhegmatogenous retinal detachment.
• Study eye: uncontrolled glaucoma (intraocular pressure [IOP] >25 mmHg on medication or according to Investigator's judgment).

SAD population only

• Presence of any contraindications, in the Investigator's opinion, to IVT anti-VEGF therapeutic administration.

Enrollment expansion population only

• Study eye: subject has received any approved or investigational treatment for exudative (wet) AMD other than vitamin supplements.
• Study eye: any current or history of macular or retinal disease other than exudative AMD
• Study eye: serous pigment epithelial detachment (PED) under the foveal center or retinal pigment epithelium (RPE) tear/rip.
• Study eye: any concurrent intraocular condition (eg, cataract, diabetic retinopathy) that, in the opinion of the Investigator, could either require medical or surgical intervention during the course of the study.
• Study eye: other ocular diseases that, in the opinion of the Investigator, can compromise the visual acuity
• Study eye: Surgery, as specified in the protocol.