Dry AMD

RG6501 (OpRegen®) Full Phase 1/2a Results to Be Featured at 2022 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Presentation by Allen C. Ho, M.D., FACS

Retrieved on: 
Monday, March 14, 2022

RG6501 (OpRegen) is currently being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech , a member of the Roche Group.

Key Points: 
  • RG6501 (OpRegen) is currently being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech , a member of the Roche Group.
  • The Association for Research in Vision and Ophthalmology, Inc. (ARVO) was founded in 1928 in Washington, DC, by a group of 73 ophthalmologists.
  • ARVO is the largest and most respected eye and vision research organization in the world.
  • ARVO advances research worldwide into understanding the visual system and preventing, treating and curing its disorders.

OpRegen® Clinical Data Continues to Demonstrate Improvements in Patients With Dry AMD With Geographic Atrophy

Retrieved on: 
Monday, May 3, 2021

OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA).

Key Points: 
  • OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA).
  • Additionally, among the newly reported data, it was notable that Cohort 4 patients reported improvements in a majority of the vision parameters measured by a validated quality of life questionnaire.
  • The magnitude of these improvements was higher overall in Cohort 4 than in Cohorts 1 through 3, which is consistent with the larger clinical benefit observed among those patients.
  • Such statements include, but are not limited to, statements relating to the expected clinical outcomes of treatment with OpRegen in dry AMD patients with GA.

Lineage Cell Therapeutics Presents Additional Interim Data on OpRegen® for Dry AMD With Geographic Atrophy

Retrieved on: 
Tuesday, March 23, 2021

OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA).

Key Points: 
  • OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA).
  • Two additional Cohort 4 patients remained within 2 letters of their baseline values (one each above and below).
  • There are two forms of AMD: wet AMD and dry AMD.
  • Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs.

Lineage Cell Therapeutics Presents New OpRegen® Data for Dry AMD With GA at 2020 American Academy of Ophthalmology Annual Meeting

Retrieved on: 
Monday, November 16, 2020

OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA).

Key Points: 
  • OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA).
  • The final four patients in the study were treated during November and will provide additional visual acuity data in the coming months.
  • These new data increasingly suggest to us that treatment with OpRegen can provide clinically meaningful outcomes in dry AMD patients with GA, particularly for those with earlier-stage disease, stated Brian M. Culley, Lineage CEO.
  • The results were presented at the 2020 American Academy of Ophthalmology Annual Meeting (AAO 2020).

Lineage Cell Therapeutics Completes Patient Enrollment in Phase 1/2a Clinical Study of OpRegen® Cell Therapy for the Treatment of Dry Age-related Macular Degeneration

Retrieved on: 
Wednesday, November 11, 2020

OpRegen is an investigational cell therapy consisting of retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA).

Key Points: 
  • OpRegen is an investigational cell therapy consisting of retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA).
  • Completion of patient enrollment in our OpRegen study is a significant achievement for our team and reflects the focused commitment we have made to advancing our three cell therapy product candidates.
  • Recently, Lineage reported the first known finding of retinal tissue regeneration in a patient receiving OpRegen for the treatment of atrophic dry AMD.
  • Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs.

Lineage Cell Therapeutics to Host Expert Call Following OpRegen® Data Update at 2020 American Academy of Ophthalmology Meeting

Retrieved on: 
Monday, November 2, 2020

OpRegen is a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD).

Key Points: 
  • OpRegen is a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD).
  • Dr. Riemann is a member of the American Society of Retina Specialists, American Academy of Ophthalmology, Ohio State Medical Association, Cincinnati Academy of Medicine, Cincinnati Ophthalmology Society, and the Association for Research in Vision and Ophthalmology.
  • Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs.
  • With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials.

Gyroscope Therapeutics Announces First Patient Received Investigational Gene Therapy GT005 Via Orbit Subretinal Delivery System in Ongoing Phase I/II FOCUS Trial

Retrieved on: 
Wednesday, October 28, 2020

Gyroscope Therapeutics Limited, a clinical-stage retinal gene therapy company, today announced that the first surgery using its proprietary Orbit Subretinal Delivery System (Orbit SDS) to deliver the companys investigational gene therapy, GT005, to a patient with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD) has been conducted in the ongoing Phase I/II FOCUS trial.

Key Points: 
  • Gyroscope Therapeutics Limited, a clinical-stage retinal gene therapy company, today announced that the first surgery using its proprietary Orbit Subretinal Delivery System (Orbit SDS) to deliver the companys investigational gene therapy, GT005, to a patient with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD) has been conducted in the ongoing Phase I/II FOCUS trial.
  • The Orbit SDS is an innovative delivery system that could address some of the challenges surgeons and patients may experience with a vitrectomy.
  • Gyroscope Therapeutics is a clinical-stage retinal gene therapy company developing gene therapy beyond rare disease to treat a leading cause of blindness, dry AMD.
  • GT005 is currently being evaluated in a Phase I/II clinical trial called FOCUS and a Phase II clinical trial called EXPLORE.

OpRegen Data Update to Be Featured in Presentation by Christopher D. Riemann, MD at 2020 American Academy of Ophthalmology Meeting

Retrieved on: 
Thursday, October 15, 2020

In addition, data from Lineage will be shown in a presentation by Allen C. Ho , M.D.

Key Points: 
  • In addition, data from Lineage will be shown in a presentation by Allen C. Ho , M.D.
  • The American Academy of Ophthalmology is the worlds largest association of eye physicians and surgeons.
  • AAO innovates to advance our profession and to ensure the delivery of the highest-quality eye care.
  • With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials.

Gemini Therapeutics Enrolls First Patient in Phase 2a Study of GEM103 for Dry Age-related Macular Degeneration

Retrieved on: 
Thursday, September 10, 2020

The safety, pharmacokinetics, and pharmacodynamics data from the Phase 1 study supports the advancement of GEM103 to a Phase 2a study.

Key Points: 
  • The safety, pharmacokinetics, and pharmacodynamics data from the Phase 1 study supports the advancement of GEM103 to a Phase 2a study.
  • As in the preceding Phase 1 study, the study will evaluate aqueous humor samples for pharmacokinetics and markers of inflammation.
  • The Phase 1 portion of the study enrolled 12 patients in a genetically screened population with dry AMD and central GA.
  • Gemini Therapeutics is examining many of these genetic variants through CLARITY, its natural history study in people with dry AMD.

Lineage Cell Therapeutics Announces Extension of OpRegen® Development Grant From Israel Innovation Authority

Retrieved on: 
Monday, July 6, 2020

The IIA has provided annual grants totaling approximately $16 million for the development of the OpRegen program so far.

Key Points: 
  • The IIA has provided annual grants totaling approximately $16 million for the development of the OpRegen program so far.
  • Concurrently, we are actively looking to identify new partnerships to help support the development of all of our programs.
  • OpRegen is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of Lineage Cell Therapeutics, Inc.
    Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs.
  • With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials.