Find Ophthalmology Drugs in Phase III Clinical Development in UNITED STATES

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            Lead Product(s): Avacincaptad Pegol

            Therapeutic Area: Ophthalmology Product Name: Zimura

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 01, 2020

            Details:

            Zimura met its pre-specified primary efficacy endpoint at 12 months and reached statistical significance in GATHER1, which was an international, multicenter, randomized, double masked, sham controlled clinical trial.

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            Lead Product(s): Bevacizumab

            Therapeutic Area: Ophthalmology Product Name: Lytenava

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 26, 2020

            Details:

            ONS-5010, an investigational ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMD, demonstrated safety and efficacy profile consistent with previously published ophthalmic bevacizumab research.

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            Lead Product(s): Atropine

            Therapeutic Area: Ophthalmology Product Name: MicroPine

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Arctic Vision

            Deal Size: $46.0 million Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement August 11, 2020

            Details:

            The agreement aims at developing and commercializing MicroPine for the treatment of progressive myopia and MicroLine for the treatment of presbyopia in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea.

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            Lead Product(s): Ketotifen Fumarate

            Therapeutic Area: Ophthalmology Product Name: EM-100

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 11, 2020

            Details:

            U.S. Food and Drug Administration (FDA) regarding its decision on the review of EM-100. EM-100’s Generic Drug User Fee Act (GDUFA) target action date was August 10th.

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            Lead Product(s): Reproxalap

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 07, 2020

            Details:

            Based on U.S. FDA meeting minutes, Aldeyra intends to initiate two clinical trials to assess the activity of reproxalap in reducing tear levels of RASP, pro-inflammatory mediators recently accepted by the FDA as an objective sign of dry eye disease.

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            Lead Product(s): Bevacizumab

            Therapeutic Area: Ophthalmology Product Name: Lytenava

            Highest Development Status: 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:

            The primary endpoint for NORSE 2 is the difference in proportion of patients who gain at least 15 letters in the best corrected visual acuity (BCVA) at 11 months for ONS-5010 dosed on a monthly basis, compared to Lucentis, which is being dosed quarterly per the PIER regimen.

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Ophthalmology Product Name: APL-2

            Highest Development Status: 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:

            A total of 1,259 patients are enrolled in DERBY and OAKS, which are pivotal randomized Phase 3 studies designed to compare the efficacy and safety of intravitreal pegcetacoplan with sham treatment in patients with GA secondary to AMD.

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            Lead Product(s): Atropine

            Therapeutic Area: Ophthalmology Product Name: MicroPine

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 30, 2020

            Details:

            The study is investigating the safety and efficacy of MicroPine for the reduction of progressive myopia using Eyenovia’s proprietary atropine topical micro-formulation delivered by the Optejet™ dispenser.

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            Lead Product(s): Avacincaptad Pegol

            Therapeutic Area: Ophthalmology Product Name: Zimura

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 30, 2020

            Details:

            First patient has been dosed in GATHER2, also known as ISEE2008, the second Phase 3 clinical trial for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

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            Lead Product(s): Bevacizumab

            Therapeutic Area: Ophthalmology Product Name: Lytenava

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 17, 2020

            Details:

            Outlook Therapeutics is currently conducting two registration clinical trials for ONS-5010. Topline results from NORSE 1, the Company’s first registration clinical trial evaluating ONS-5010 and providing clinical experience and initial safety and efficacy.

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