LX102 / Innostellar Biotherap - LARVOL DELTA

Subretinal rAAV2-based VEGF-Trap gene therapy for neovascular age-related macular degeneration: Preclinical assessment and phase 1 trial results. (PubMed, Cell Rep Med) - P1 | "These findings support LX102 as a potential sustained therapeutic approach for nAMD. This study was registered at chinadrugtrials.org.cn (CTR20230194) and ClinicalTrials.gov (NCT06198413)."

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

Subretinal LX102 gene therapy for neovascular age-related macular degeneration (nAMD): 1-year results of a randomized, active-controlled phase 2 trial (ARVO 2026) - P2 | "Conclusions Safety results from phase 2 dose expansion trial evaluating subretinal LX102 injection in nAMD participants were consistent with observations from phase 1 trial, with no clinically determined ocular inflammation in 5×1010 VG/eye group. And efficacy results support LX102 gene therapy as a potential treatment option to reduce the burden of frequent anti-VEGF treatments and maintain long-term visual outcomes."

Clinical • Gene therapy • P2 data • Age-related Macular Degeneration • Cataract • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR) (clinicaltrials.gov) - P3 | N=332 | Recruiting | Sponsor: Innostellar Biotherapeutics Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Phase III, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Subretinal Injection of LX102 in Participants with Neovascular Age-Related Macular Degeneration – The STELLAR Trial (ChiCTR) - P3 | N=332 | Recruiting | Sponsor: Shanghai General Hospital; Shanghai Langsheng Biotechnology Co., Ltd

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR) (clinicaltrials.gov) - P3 | N=332 | Not yet recruiting | Sponsor: Innostellar Biotherapeutics Co.,Ltd

New P3 trial • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD) (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Innostellar Biotherapeutics Co.,Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Safety and Efficacy of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS) (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: Innostellar Biotherapeutics Co.,Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: May 2029 ➔ Oct 2029

Enrollment closed • Trial completion date • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Subretinal LX102 gene therapy for neovascular age-related macular degeneration (nAMD): 9-month follow-up of a phase 1 clinical trial (ARVO 2024) - "Subretinal LX102 injection was well tolerated in nAMD subjects. And these results support LX102 gene therapy as a potential treatment option to reduce the burden of frequent anti-VEGF treatments and maintain the best long-term visual outcomes."

Clinical • Gene therapy • P1 data • Age-related Macular Degeneration • Diabetic Retinopathy • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Subretinal LX102 gene therapy for neovascular age-related macular degeneration (nAMD): 1 year follow-up of an investigator initiated trial (ARVO 2024) - "Subretinal LX102 injection was well tolerated in nAMD subjects. And these results support LX102 gene therapy as a potential treatment option to reduce the burden of anti-VEGF treatments and maintain long-term visual outcomes."

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