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Find Ophthalmology Drugs in Phase I Clinical Development in UNITED STATES

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            Lead Product(s): GEM103

            Therapeutic Area: Ophthalmology Product Name: GEM103

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: FS Development Corp

            Deal Size: $216.0 million Upfront Cash: Undisclosed

            Deal Type: Merger October 15, 2020

            Details:

            Proceeds from the transaction are expected to provide Gemini with the capital needed to further develop its clinical programs and preclinical portfolio, including GEM103, Further clinical programs in selected wet AMD populations, Future programs to treat intermediate AMD.

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            Lead Product(s): AAV.7m8-Aflibercept

            Therapeutic Area: Ophthalmology Product Name: ADVM-022

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 10, 2020

            Details:

            Early evidence from Cohort 4, consistent with Cohort 3, suggests that a prophylactic regimen of steroid eye drops results in fewer adverse events and less inflammation, when compared to a prophylactic regimen of oral steroids as used in Cohorts 1 and 2. In Cohorts 3 and 4.

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            Lead Product(s): LBS-008

            Therapeutic Area: Ophthalmology Product Name: BPN-14967

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 20, 2020

            Details:

            A total of 83 subjects were administered with LBS-008 either as a single dose or repeated doses for 14 consecutive days. Both studies concluded that pharmacological doses of LBS-008 were well tolerated and that LBS-008's PK / PD profile supports daily oral administration.

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            Lead Product(s): AAV.7m8-aflibercept

            Therapeutic Area: Ophthalmology Product Name: ADVM-022

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 06, 2020

            Details:

            Adverum Biotechnologies announced the completion of patient dosing in Cohort 4 of OPTIC, a Phase 1 clinical trial, assessing a single intravitreal (IVT) injection of ADVM-022 in patients with wet age-related macular degeneration (AMD).

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            Lead Product(s): Ciclosporin

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 12, 2020

            Details:

            The study will evaluate safety and tolerability of OTX-CSI and assess biological activity by measuring signs and symptoms of DED over this time period.

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            Lead Product(s): Antolimab

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 11, 2020

            Details:

            The presentation will showcase results from Phase 1b Study of an Anti-Siglec-8 Monoclonal Antibody, Antolimab (AK002), in Severe Allergic Conjunctivitis.

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            Lead Product(s): AAV.7m8-aflibercept

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 04, 2020

            Details:

            In the OPTIC Phase 1 Trial ADVM-022 continued to show robust efficacy. Long-term durability beyond 1 year from a single IVT injection with zero rescue injections in Cohort 1.

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            Lead Product(s): AAV.7m8-aflibercept

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 30, 2020

            Details:

            Adverum Biotechnologies to present data of ADVM-022 Intravitreal Gene Therapy for Neovascular AMD - results from the Phase 1 OPTIC Study.

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            Lead Product(s): AAV.7m8-aflibercept

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 27, 2020

            Details:

            Patients in Cohort 4 are receiving a single intravitreal injection of gene therapy candidate ADVM-022 and are receiving steroid eye drop prophylaxis for six weeks (same as Cohort 3).

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            Lead Product(s): OTX-TKI

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 03, 2020

            Details:

            Two cohorts of six subjects each have been enrolled, a lower dose cohort of 200 ?g and a higher dose cohort of 400 ?g.

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