SKG0106 / Skyline Therap - LARVOL DELTA

SKG0106-002: A Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Wang Min | Initiation date: Jan 2024 ➔ May 2024

Trial initiation date • Diabetic Macular Edema • Ophthalmology

Preclinical and Phase I Clinical Trial Update of the Safety and Efficacy of SKG0106, a Novel AAV Gene Therapy Product for the Treatment of Neovascular Age-Related Macular Degeneration (ASGCT 2024) - "In the rabbit dose range finding (DRF) study, SKG0106 in the dose range of 1E9 to 3E10 vg/eye showed comparable efficacy profiles as Eylea® and lasted until the end of the study (6 weeks) while Eylea® already lost its activity. Asymptomatic trace vitreous cells were observed in a single episode of follow-up 12-16 weeks in patients treated with 7.2E10 vg/eye, which resolved without intervention. More clinical results on BCVA, CST, and Vb24 in AH will be presented at the ASGCT meeting."

Gene therapy • P1 data • Preclinical • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Positive Interim Results of Intravitreally delivered SKG0106 Phase 1 Clinical Trial in Patients with nAMD (ARVO 2024) - "Full data from this trial are expected to be presented at this ARVO meeting."

Clinical • P1 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

SKG0106, an AAV vector delivered intravitreally, for effective, safe and durable treatment of nAMD (ARVO 2024) - "SKG0106 in the dose-range of 1E9 to 3E10 vg/eye showed comparable efficacy profiles vs. that of Eylea®. With the support from all these data, INDs for the vector have been approved in both the US and China, and the clinical trial is on-going."

Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD (clinicaltrials.gov) - P=N/A | N=83 | Recruiting | Sponsor: Skyline Therapeutics

New trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Wang Min

New P1 trial • Diabetic Macular Edema • Ophthalmology

A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD) (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Youxin Chen

New P1 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD) (clinicaltrials.gov) - P1/2 | N=68 | Recruiting | Sponsor: Skyline Therapeutics (US) Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2029 ➔ Jan 2026

Enrollment open • Trial completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Skyline Therapeutics Receives China NMPA's Approval of IND for SKG0106, a Novel Intravitreally Delivered AAV Gene Therapy Candidate for Neovascular Age-related Macular Degeneration (PRNewswire) - "Skyline Therapeutics...today announced that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for SKG0106, a one-time intravitreally delivered AAV gene therapy for the treatment of neovascular age-related macular degeneration (nAMD)."

Non-US regulatory • Age-related Macular Degeneration

Phase I/II Study to Evaluate the Safety, Preliminary Efficacy, Immunogenicity, and Pharmacokinetics of SKG0106 Intraocular Solution in Patients With Neovascular Age-related Macular Degeneration (nAMD) (clinicaltrials.gov) - P1/2 | N=68 | Not yet recruiting | Sponsor: Skyline Therapeutics (US) Inc. | Initiation date: Mar 2023 ➔ Oct 2023

Trial initiation date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Phase I/II Study to Evaluate the Safety, Preliminary Efficacy, Immunogenicity, and Pharmacokinetics of SKG0106 Intraocular Solution in Patients With Neovascular Age-related Macular Degeneration (nAMD) (clinicaltrials.gov) - P1/2 | N=68 | Active, not recruiting | Sponsor: Skyline Therapeutics (US) Inc.

New P1/2 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration