Delving into the Latest Updates on LX102(Innostellar) with Synapse

Overview

Basic Info

Drug Type

AAV based gene therapy

Synonyms

LX 102(Innostellar Biotherapeutics), LX-102(Innostellar Biotherapeutics), LX102(Innostellar Biotherapeutics)

+ [1]

Target

VEGF

Action

modulators

Mechanism

VEGF modulators(Vascular endothelial growth factor modulators)

Therapeutic Areas

Congenital DisordersEye Diseases

Active Indication

Wet age-related macular degeneration

Inactive Indication-

Originator Organization

Innostellar Biotherapeutics Co., Ltd.Ltd.

Active Organization

Innostellar Biotherapeutics Co., Ltd.Ltd.Shanghai Langsheng Biotechnology Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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This is 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 study will evaluate a single subretinal injection of LX102 compared to an active comparator. The primary endpoint of this study is the mean change from D0 in BCVA based on an average at weeks 40 and 48.

Start Date14 Jan 2026

Sponsor / Collaborator

Shanghai Langsheng Biotechnology Co., Ltd.

ChiCTR2500115643

/ RecruitingPhase 3IIT

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

Start Date01 Jan 2026

Sponsor / Collaborator

Shanghai First People's Hospital

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NCT06196840

/ Active, not recruitingPhase 2

A Phase 2, Randomized Controlled, Open-Label Study to Establish the Safety and Efficacy of LX102 in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)

The goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD.

Start Date24 Jan 2024

Sponsor / Collaborator

Shanghai Langsheng Biotechnology Co., Ltd.

100 Clinical Results associated with LX102(Innostellar)

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100 Translational Medicine associated with LX102(Innostellar)

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100 Patents (Medical) associated with LX102(Innostellar)

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1

Literatures (Medical) associated with LX102(Innostellar)

01 Feb 2026·Ophthalmology science

Intravitreal Gene Therapy with LX102-C01 in Neovascular Age-Related Macular Degeneration: A Phase I Dose-Escalation Study of 12-Month Safety and Efficacy Outcomes

Article

Author: Gong, YuanYuan ; Wang, Ruikang K ; Wang, Fenghua ; Jia, Huixun ; Zhou, Yanping ; Li, Tong ; Rosenfeld, Philip J ; Shen, Mengxi ; Yang, Xiaolu ; Wu, Yidong ; Chen, Jieqiong ; Sun, Junran ; Feng, Jingyang ; Wang, Hong ; Liu, Yang ; Cheng, Yuxuan ; Sun, Xiaodong

Purpose:

To assess the safety, tolerability, and preliminary efficacy of a single intravitreal injection of LX102-C01 in eyes with neovascular age-related macular degeneration (nAMD) followed up to 52 weeks.

Design:

Open-label, single-center, dose-escalation investigator-initiated trial (NCT05831007) with 2 cohorts (3E10 vector genome [vg] and 1E11 vg per eye).

Subjects:

Eyes with choroidal neovascularization secondary to nAMD, subretinal or intraretinal fluid, and a history of >2 anti-VEGF treatments in the past 6 months with a good response.

Methods:

All patients received 1 injection of aflibercept 2 weeks before LX102-C01. Dose escalation started with 3E10 vg and increased to 1E11 vg per eye. Visual acuity, anatomy, and adverse events (AEs) were assessed. Macular choroidal thickness (CT) and vascularity were measured using a 6 × 6 mm scan on swept-source OCT angiography imaging.

Main Outcome Measures:

The primary endpoint was AEs at 1 year. The secondary endpoints were best-corrected visual acuity (BCVA), central subfield thickness (CST), and incidence of rescue treatment. Exploratory endpoints included the macular hypoautofluorescent area, CT, and choroidal vascularity index (CVI).

Results:

Six eyes of 6 patients were included. There were no LX102-C01-related nonocular AEs. All LX102-C01-related ocular AEs were mild, predominantly anterior inflammation. There was no evidence of vasculitis, retinitis, choroiditis, vascular occlusions, or endophthalmitis. Two eyes from 2 patients developed recurrent subretinal fluid or hemorrhages that did not meet rescue criteria and resolved spontaneously after 1 to 2 months. All patients were free of rescue anti-VEGF treatments till the latest visit. Compared to baseline, BCVA maintained and CST decreased up to 12 months in both cohorts. The area of hypo-autofluorescence remained stable in both groups. The mean choroidal thickness (MCT) decreased from 162.1 μm to 147.1 μm (P = 0.03), but the CVI measurement showed no significant change (P = 0.6) up to 12 months. Changes in the MCT and CVI showed no statistically significant differences compared with the control group receiving standard aflibercept treatment.

Conclusions:

LX102-C01 showed a favorable safety profile and potential efficacy in this preliminary 52-week study, with no observed macular atrophy, suggesting short-term tolerability of gene therapy associated anti-VEGF expression.

Financial Disclosures:

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

100 Deals associated with LX102(Innostellar)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Wet age-related macular degeneration	Phase 3	China	Shanghai Langsheng Biotechnology Co., Ltd.	01 Jan 2026

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05831007 (EURETINA2024) Manual	Not Applicable	Wet age-related macular degeneration	6	LX102-C01 gene therapy 3 × 1010 vg	mgjmqblfvz(mqjyeubtsw) = Intravitreal injection of LX102-C01 was safe and generally well tolerated during 2 years of follow up. No LX102-C01-related serious adverse events were noted; anterior uveitis was reported in 5 subjects, and were all generally mild and resolved with topical corticosteroid. No evidence of vasculitis, retinitis, choroiditis, vascular occlusions or endophthalmitis was reported. qfmquawarw (frrkhbgrlb ) View more	Positive	19 Sep 2024
ARVO2024	Not Applicable	Wet age-related macular degeneration	5	LX102aflibercept + LX102aflibercept	ddkicpymnz(cmiciiabnv) = Subretinal injection of LX102 was overall well tolerable. No LX102-related adverse events were noted; procedure-related adverse events (conjunctival hyperemia, post-operative visual acuity reduction and mild cell debris in the anterior vitreous) were generally mild and self-resolving. rkbbomawjc (olckhnjjha )	Positive	05 May 2024
CTR20230194 (ARVO2024)	Phase 1	Wet age-related macular degeneration	9	LX102 low-dose cohort	imfskpkqty(wwdgoxugic) = Subretinal injection of LX102 was generally well tolerated. No LX102-related adverse events were noted; post-operative adverse events, i.e., conjunctival hyperemia (67% of subjects) and increased intraocular pressure (IOP) (11.1% of subjects) were generally mild and resolved within days to weeks. No evidence of vasculitis, retinitis, choroiditis, vascular occlusions or endophthalmitis was reported. txhtkamvtv (xksdtcynwh )	Positive	05 May 2024
CTR20230194 (ARVO2024)	Phase 1	Wet age-related macular degeneration	9	LX102 medium-dose cohort		Positive	05 May 2024