FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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Find Ophthalmology Drugs in Phase I/II Clinical Development in UNITED STATES

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            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.

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            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.

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            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).

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            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).

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            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.

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            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.

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            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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            Lead Product(s): AGTC-501

            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 February 19, 2020

            Details:

            The Phase 1/2 clinical trial is evaluating the safety and efficacy of sub-retinal injection of AGTC-501 for the treatment of X-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene.

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            Lead Product(s): Retinal pigment epithelial cell

            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 February 06, 2020

            Details:

            All five patients in Cohort 4, those with better baseline vision and which represent the Company’s intended patient population, have shown increases in best corrected visual acuity (BCVA).

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            Lead Product(s): Adeno-associated virus-based gene therapy

            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 January 23, 2020

            Details:

            Encouraging preliminary signs of biologic activity and a favorable safety profile are outcomes that are clinically relevant to patients.

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