FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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            Lead Product(s): KSI-301

            Therapeutic Area: Ophthalmology Product Name: KSI-301

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 07, 2020

            Details:

            New data from the ongoing Phase 1b study of KSI-301, its novel anti-VEGF antibody biopolymer conjugate, will be presented at the upcoming American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting.

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            Lead Product(s): Voclosporin

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 22, 2020

            Details:

            Aurinia has completed enrollment for the Phase 2/3 AUDREY™ clinical trial evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES), a chronic disease estimated to affect more than 16 million people in the United States.

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            Lead Product(s): rAAV2-ND4

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 11, 2020

            Details:

            Results of two clinical studies utilizing NFS-01 in the treatment of Leber's Hereditary Optic Neuropathy will be presented in May 2020 at the ASGCT Annual Meeting.