Ophthalmology | Phase III Developments

Novartis Pharmaceuticals Corporation

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Switzerland

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CFRT 2020

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Novartis Reports Positive Topline Results from the First Phase III Trial of Beovu® Vs Aflibercept in Patients with Diabetic Macular Edema

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).

Nicox SA

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FRANCE France

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CFRT 2020

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Nicox Completes Enrollment of the Adaptive Design Cohort of NCX 470 Mont Blanc Phase 3 Glaucoma Trial

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.

IVERIC bio

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United States

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CFRT 2020

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IVERIC Bio Publishes GATHER1 Phase 3 Clinical Trial Results for Zimura® in Geographic Atrophy Secondary to Age-related Macular Degeneration

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.

GtreeBNT

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Korea, Republic Of

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CFRT 2020

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RegeneRx Joint Venture GtreeBNT Expects to Complete Phase 3 Dry Eye Trial in November 2020

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.

Outlook Therapeutics

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United States

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CFRT 2020

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Outlook Therapeutics Reports Topline Results and Positive Proof-of-Concept for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) from NORSE 1

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.

Mitotech

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Luxembourg

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CFRT 2020

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Mitotech and Essex Bio-Technology Complete Enrollment in VISTA-2 – a pivotal Phase 3 Clinical Study of SkQ1 for Dry Eye Disease

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.

Eyenovia

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United States

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CFRT 2020

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Eyenovia and Arctic Vision Ink License Agreement to Develop and Commercialize MicroPine and MicroLine in Greater China and South Korea

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.

Eton Pharmaceuticals

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United States

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CFRT 2020

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Eton Pharmaceuticals Provides Update on the FDA Review of EM-100

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.

F. Hoffmann-La Roche

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Switzerland

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CFRT 2020

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Favorable PhIII data for Roche’s Port Delivery System with ranibizumab for neovascular ARMD

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.

GenSight Biologics

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FRANCE France

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CFRT 2020

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GenSight Reports Final REALITY Natural History Study Results Confirming Poor Spontaneous Recovery for LHON Patients With ND4 Mutation

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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Find Ophthalmology Drugs in Phase III Clinical Development

Phase III

Product Type

Companies

Novartis Pharmaceuticals Corporation

Novartis Reports Positive Topline Results from the First Phase III Trial of Beovu® Vs Aflibercept in Patients with Diabetic Macular Edema

Nicox SA

Nicox Completes Enrollment of the Adaptive Design Cohort of NCX 470 Mont Blanc Phase 3 Glaucoma Trial

IVERIC bio

IVERIC Bio Publishes GATHER1 Phase 3 Clinical Trial Results for Zimura® in Geographic Atrophy Secondary to Age-related Macular Degeneration

GtreeBNT

RegeneRx Joint Venture GtreeBNT Expects to Complete Phase 3 Dry Eye Trial in November 2020

Outlook Therapeutics

Outlook Therapeutics Reports Topline Results and Positive Proof-of-Concept for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) from NORSE 1

Mitotech

Mitotech and Essex Bio-Technology Complete Enrollment in VISTA-2 – a pivotal Phase 3 Clinical Study of SkQ1 for Dry Eye Disease

Eyenovia

Eyenovia and Arctic Vision Ink License Agreement to Develop and Commercialize MicroPine and MicroLine in Greater China and South Korea

Eton Pharmaceuticals

Eton Pharmaceuticals Provides Update on the FDA Review of EM-100

F. Hoffmann-La Roche

Favorable PhIII data for Roche’s Port Delivery System with ranibizumab for neovascular ARMD

GenSight Biologics

GenSight Reports Final REALITY Natural History Study Results Confirming Poor Spontaneous Recovery for LHON Patients With ND4 Mutation