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타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 다음 갱신 D-6 · 마지막 9월 2일

현재 선택: 2 · 임상 갱신 필요 1 · Data Tier에서 열림

프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.

API CSV27행 · 2개 프로그램

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항목
CGTCurated CoreFDAApproved
voretigene neparvovec (Luxturna, AAV2-hRPE65v2, voretigene neparvovec-rzyl)
Spark Therapeutics / Roche·RPE65 (AAV2)
7 trials
CGTStandard DatabasestalePhase 2
4D-150 IVT (4D-150 IVT)
4D Molecular Therapeutics·Diabetic Macular Edema
4 trials
Overview
Program
Luxturna (voretigene neparvovec)4D-150 IVT
Overview
Company
Spark Therapeutics / Roche4D Molecular Therapeutics
Overview
Modality
CGTCGT
Overview
Target
RPE65 (AAV2)Diabetic Macular Edema
Overview
Indication
Inherited retinal dystrophy due to confirmed biallelic RPE65 mutationsDiabetic Macular Edema; Diabetic Retinopathy
Overview
Phase
APPROVEDPHASE_2
Overview
Status
APPROVEDRECRUITING
Overview
Content status
Curated CoreStandard Database
Overview
Data Confidence
Data Confidence · HighData Confidence · Medium
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · Emerging
Overview
Approval status
FDA approvedInvestigational
Positioning
Key differentiator
Surgical subretinal delivery; landmark ophthalmology gene therapy
Positioning
Known limitation
bypasses defective phototransduction pathways, showing promise for patients regardless of their genetic profile
Positioning
Development positioning
Only approved RPE65 gene therapy
Technology
Vector
AAV2
MoA
Mechanism
Voretigene neparvovec uses AAV2 to deliver functional RPE65 to retinal pigment epithelium, restoring the visual cycle and improving light sensitivity in RPE65-mutant IRD.
MoA
Biomarker
MLMT, FST, BCVA.
PK/PD
Species
NHP, Despite these findings, and no systemic toxicity was identified.
PK/PD
Animal (cat.)
NHP
PK/PD
Experiment
biodistribution
Toxicology
Species
NHP, Dog, Despite these findings, and no systemic toxicity was identified.
Toxicology
Animal (cat.)
NHP, Dog
Toxicology
Major finding
Procedure-related ocular AEs; inflammation manageable with steroids
Clinical
Safety signal
Procedure-related ocular AEs; inflammation manageable with steroids
Clinical
Program phase
APPROVEDPHASE_2
Clinical
Trial activity
4 recruiting · 3 completed4 recruiting
Preclinical
Animal (cat.)
NHP