Ophthalmology | Phase I/ Phase II Developments

Lineage Cell Therapeutics

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United States

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

Lead Product(s): Retinal pigment epithelium cell transplant therapy

Therapeutic Area: Ophthalmology Product Name: OpRegen

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Israel Innovation Authority

Deal Size: $16.0 million Upfront Cash: Undisclosed

Deal Type: Funding July 06, 2020

Details:

As a result of continued clinical progress, the Israel Innovation Authority has extended its previously awarded development grant in support of OpRegen®, Company’s retinal pigment epithelium cell transplant therapy in development for the treatment of dry AMD.

Tarsius Pharma

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ISRAEL Israel

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Tarsius Pharma Completes Patient Enrollment in Clinical Trial of TRS01 in Patients With Non-infectious Uveitis

Lead Product(s): TRS01

Therapeutic Area: Ophthalmology Product Name: TRS01

Highest Development Status: Phase I/ Phase II Product Type: Undisclosed

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 22, 2020

Details:

TRS01 is a Potential topical immune-modulator agent with a novel mechanism of action for treatment of ocular inflammation. This phase I/II trial is a dose ranging trial to evaluate the safety and efficacy of TRS01 in patients with anterior non-infectious active uveitis.

Lineage Cell Therapeutics

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Lineage Cell Therapeutics Reinitiates Patient Enrollment in Clinical Study of OpRegen® for the Treatment of Dry AMD With Geographic Atrophy

Lead Product(s): Retinal pigment epithelial cells

Therapeutic Area: Ophthalmology Product Name: OpRegen

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 18, 2020

Details:

The company has restarted patient enrollment in a Phase 1/2a study of OpRegen a retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration.

Lineage Cell Therapeutics

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Lineage Cell Therapeutics to Present Tomorrow at 2020 Raymond James Human Health Innovation Conference

Lead Product(s): Retinal pigment epithelial cells

Therapeutic Area: Ophthalmology Product Name: OpRegen

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 17, 2020

Details:

Lineage Cell Therapeutics will provide an update on the status of Lineage’s lead program, OpRegen®, an allogeneic retinal pigment epithelium (RPE) transplant therapy for dry age-related macular degeneration (AMD).

Lineage Cell Therapeutics

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Lineage Cell Therapeutics Reports Regeneration of Retinal Tissue in Patient Treated With OpRegen RPE Cells for Dry AMD With Geographic Atrop...

Lead Product(s): OpRegen RPE Cells

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2020

Details:

Restoration of retinal tissue was observed in a patient enrolled in a Phase 1/2a study of its lead product candidate, OpRegen®, a retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of dry age-related macular degeneration (AMD).

Lineage Cell Therapeutics

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Lineage Cell Therapeutics Reports New Data With OpRegen for the Treatment of Dry AMD With Geographic Atrophy

Lead Product(s): OpRegen

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 06, 2020

Details:

The presentation showcases results from a Phase I/IIa study of Lineage's lead product, OpRegen®, a retinal pigment epithelium cell transplant therapy for the treatment Dry AMD with Geographic Atrophy.

Regenxbio

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United States

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Regenxbio Announces Additional Positive Long-Term and Interim Phase I/Iia Trial Update for RGX-314 for the Treatment of Wet AMD

Lead Product(s): Rgx-314

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 22, 2020

Details:

RGX-314 continues to be well-tolerated at all dose levels . Long-term, durable treatment effect demonstrated over two years in Cohort 3.

GenSight Biologics

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FRANCE France

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GenSight Biologics Announces Positive Data Safety Monitoring Board Review of PIONEER Phase I/II Trial of GS030

Lead Product(s): GS030

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 14, 2020

Details:

The DSMB confirmed the absence of any safety issues for the second cohort of three subjects in PIONEER Phase I/II clinical trial of GS030.

Opthea

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Australia

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Opthea Completes Patient Dosing in Phase 2a DME Trial

Lead Product(s): OPT-302,Aflibercept

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 30, 2020

Details:

Opthea completed patient dosing and all follow-up week 12 patient visits in the Phase 2a trial evaluating the safety and efficacy of OPT-302 administered in combination with aflibercept.

Editas Medicine

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United States

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First patient treated with CRISPR medicine in phase 1/2 trial

Lead Product(s): AGN-151587

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 04, 2020

Details:

The BRILLIANCE clinical trial is evaluating AGN-151587 (EDIT-101) in patients with Leber congenital amaurosis 10 (LCA10). It is the first gene editing medicine to be evaluated inside the body.

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Find Ophthalmology Drugs in Phase I/II Clinical Development

Phase I/ Phase II

Product Type

Companies

Lineage Cell Therapeutics

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

Tarsius Pharma

Tarsius Pharma Completes Patient Enrollment in Clinical Trial of TRS01 in Patients With Non-infectious Uveitis

Lineage Cell Therapeutics

Lineage Cell Therapeutics Reinitiates Patient Enrollment in Clinical Study of OpRegen® for the Treatment of Dry AMD With Geographic Atrophy

Lineage Cell Therapeutics

Lineage Cell Therapeutics to Present Tomorrow at 2020 Raymond James Human Health Innovation Conference

Lineage Cell Therapeutics

Lineage Cell Therapeutics Reports Regeneration of Retinal Tissue in Patient Treated With OpRegen RPE Cells for Dry AMD With Geographic Atrop...

Lineage Cell Therapeutics

Lineage Cell Therapeutics Reports New Data With OpRegen for the Treatment of Dry AMD With Geographic Atrophy

Regenxbio

Regenxbio Announces Additional Positive Long-Term and Interim Phase I/Iia Trial Update for RGX-314 for the Treatment of Wet AMD

GenSight Biologics

GenSight Biologics Announces Positive Data Safety Monitoring Board Review of PIONEER Phase I/II Trial of GS030

Opthea

Opthea Completes Patient Dosing in Phase 2a DME Trial

Editas Medicine

First patient treated with CRISPR medicine in phase 1/2 trial