OpRegen (RG6501)
/ Lineage Cell Therap, Roche
- LARVOL DELTA
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May 12, 2025
RG6501 (OpRegen) Phase 1/2a Clinical Study 36 Month Results to Be Featured at Clinical Trials at the Summit 2025
(Businesswire)
- "Lineage Cell Therapeutics, Inc....today announced that 36-month results from patients enrolled in a Phase 1/2a clinical study...of RG6501 (OpRegen) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), will be presented at Clinical Trials at the Summit (CTS) 2025."
P1/2 data • Age-related Macular Degeneration
February 21, 2025
A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette)
(clinicaltrials.gov)
- P2 | N=60 | Recruiting | Sponsor: Genentech, Inc. | Trial completion date: Apr 2029 ➔ Mar 2031 | Trial primary completion date: Apr 2029 ➔ Mar 2031
Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders
December 27, 2024
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
(clinicaltrials.gov)
- P1/2 | N=24 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Jul 2025 ➔ Jan 2031
Trial completion date • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Transplantation
November 05, 2024
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
(clinicaltrials.gov)
- P1/2 | N=24 | Active, not recruiting | Sponsor: Genentech, Inc.
Metastases • New P1/2 trial • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Transplantation
April 15, 2024
OpRegen retinal pigment epithelial (RPE) cell therapy engrafts within the RPE of Gottingen mini-pigs by 4-weeks post-administration via subretinal delivery
(ARVO 2024)
- "Engraftment of OpRegen was demonstrated in this large animal surgical model. The similar size of the minipig eye compared to human eyes provides a useful model for evaluating surgical procedures intended for human use. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."
Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Ophthalmology • Retinal Disorders • PMEL
January 16, 2024
RG6501 (OpRegen) Phase 1/2a Results Will Be Featured at 2024 Angiogenesis Exudation and Degeneration Meeting in Presentation by Allen Ho, MD, FACS, FASRS
(Businesswire)
- "Lineage Cell Therapeutics, Inc...announced that results showing retinal structure improvements with RG6501(OpRegen) from a Phase 1/2a clinical study (ClinicalTrials.gov Identifier: NCT02286089) in geographic atrophy (GA) secondary to advanced age-related macular degeneration (AMD), will be presented at the 2024 Angiogenesis, Exudation, and Degeneration Meeting. The virtual meeting will be held February 3, 2024, and is sponsored by the University of Miami Health System Bascom Palmer Eye Institute."
P1/2 data • Age-related Macular Degeneration • Ophthalmology
November 18, 2023
A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
(clinicaltrials.gov)
- P2 | N=60 | Recruiting | Sponsor: Genentech, Inc. | Phase classification: P2a ➔ P2
Phase classification • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders
June 27, 2023
"All will bend the knee to Opregen $LCTX @genentech"
(@JohnPDalyJr)
June 08, 2023
"All will bend the knee to Opregen and $LCTX"
(@JohnPDalyJr)
May 26, 2023
"All will bend the knee to Opregen $LCTX and @Roche"
(@JohnPDalyJr)
May 16, 2023
A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
(clinicaltrials.gov)
- P2a | N=60 | Recruiting | Sponsor: Genentech, Inc. | Trial completion date: Sep 2029 ➔ Apr 2029 | Trial primary completion date: Sep 2029 ➔ Apr 2029
Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders
May 01, 2023
"All will bend the knee to Opregen and @Roche $LCTX."
(@JohnPDalyJr)
April 16, 2023
"4/#OpRegen is being developed under a worldwide collaboration between @LineageCell, @Roche & @Genentech - a member of the $RHHBY Group. $LCTX has already received $50M up front payment and is eligible for an additional $620M of milestone payments as well as double-digit royalties"
(@yaireinhorn)
April 06, 2023
Exploratory optical coherence tomography (OCT) analysis in patients with geographic atrophy (GA) treated by OpRegen: Results from the Phase 1/2a trial
(ARVO 2023)
- P1/2, P2a | "Some participants in this early phase clinical trial have demonstrated structural and functional improvement that is maintained at 1 year after the therapy. Enrollment in this early phase clinical trial is complete but patients continue in long-term follow-up in the US and Israel."
Clinical • P1/2 data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders
March 28, 2023
"Did either comment on market size? Following OpRegen $LCTX trial with @genentech"
(@josephnparsons)
March 28, 2023
"#OpRegen abstract for ARVO is out and on the ARVO website. You can search for it there."
(@SPS614)
March 20, 2023
"$LCTX at @ARVOinfo April to share new data on OpRegen. Or is @GenentechEye presenting?"
(@josephnparsons)
Ophthalmology
January 20, 2023
"No mention of OpRegen with Roche and Lineage?"
(@josephnparsons)
January 17, 2023
A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
(clinicaltrials.gov)
- P2a | N=60 | Recruiting | Sponsor: Genentech, Inc. | Not yet recruiting ➔ Recruiting
Enrollment open • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders
December 13, 2022
"@genentech $LCTX Opregen back in the clinic reversing dry AMD."
(@JohnPDalyJr)
Dry Age-related Macular Degeneration
November 29, 2022
"Is Lineage making OpRegen? Thanks"
(@josephnparsons)
November 26, 2022
"OpRegen."
(@josephnparsons)
November 23, 2022
A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
(clinicaltrials.gov)
- P2a | N=60 | Not yet recruiting | Sponsor: Genentech, Inc.
New P2a trial • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders
November 04, 2022
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
(clinicaltrials.gov)
- P1/2 | N=24 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Dec 2021
Trial completion • Trial completion date • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Transplantation
July 14, 2022
"Get cracking on Opregen."
(@JohnPDalyJr)
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