Find Ophthalmology Drugs in Phase III Clinical Development

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            Lead Product(s): Brolucizumab

            Therapeutic Area: Ophthalmology Product Name: Beovu

            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 14, 2020

            Details:

            In Phase III KITE study, Beovu (brolucizumab) 6 mg achieved its primary endpoint of non-inferiority to aflibercept 2 mg in mean change in best-corrected visual acuity (BCVA) at year one (week 52).

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            Lead Product(s): NCX 470

            Therapeutic Area: Ophthalmology Product Name: NCX 470

            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 September 02, 2020

            Details:

            Nicox completed enrollment of adaptive design patient cohort in its multicenter Mont Blanc Phase 3 trial, evaluating NCX 470 ophthalmic solution vs. latanoprost ophthalmic solution, 0.005% for the lowering intraocular pressure in open-angle glaucoma or ocular hypertension.

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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): Thymosin Beta-4

            Therapeutic Area: Ophthalmology Product Name: RGN-259

            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 31, 2020

            Details:

            ARISE-3 is designed to assess the safety and efficacy of 0.1% RGN-259 eye drops compared to placebo after two weeks of administration in 700 subjects with dry eye syndrome.

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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): Visomitin

            Therapeutic Area: Ophthalmology Product Name: SkQ1

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Essex Bio

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 25, 2020

            Details:

            VISTA-2 is a multi-centre, randomized, double-blind, placebo-controlled clinical study involving two treatment arms: SkQ1 ophthalmic solution and vehicle solution, administered BID.

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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): Ranibizumab

            Therapeutic Area: Ophthalmology Product Name: Lucentis

            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 22, 2020

            Details:

            In the Archway study, Port Delivery System with ranibizumab (PDS) demonstrated non-inferior and equivalent visual acuity outcomes compared with monthly ranibizumab eye injections, and a favourable benefit-risk profile.

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            Lead Product(s): Lenadogene nolparvovec

            Therapeutic Area: Ophthalmology Product Name: Lumevoq

            Highest Development Status: 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 July 21, 2020

            Details:

            Statistical analysis of the visual acuity in 23 REALITY subjects aged 15 or older with a mutated ND4 gene shows that on average, vision failed to recover from an initial sudden decline, even several years after vision loss.

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