Ophthalmology | Phase III Developments | UNITED STATES

IVERIC bio

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IVERIC bio Announces First Patient Dosed in Second Zimura® Phase 3 Clinical Trial

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)

Eyenovia

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Eyenovia Resumes Recruitment of Phase III CHAPERONE Study for Progressive Myopia

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.

Outlook Therapeutics

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Outlook Therapeutics Provides Clinical Update on ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

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.

IVERIC bio

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IVERIC bio Announces Positive Zimura 18 Month Data Supporting the 12 Month Efficacy Findings

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 15, 2020

Details:

IVERIC Bio announced positive 18 month results from the Company's first Phase 3 clinical trial (OPH2003) for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Aldeyra Therapeutics

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Aldeyra Therapeutics Receives Orphan Medicinal Product Designation from the European Commission for ADX-2191 Retinal Disease Program

Lead Product(s): Methotrexate

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 June 15, 2020

Details:

ADX-2191 is an investigational therapy in clinical development in the U.S. for the prevention of proliferative vitreoretinopathy (PVR), a rare but serious sight-threatening retinal disease with no approved treatment.

IVERIC bio

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IVERIC bio to Announce Zimura® 18 Month Data from the OPH2003 Phase 3 Clinical Trial in Geographic Atrophy Secondary to Age-Related Macular...

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 14, 2020

Details:

IVERIC will report 18 month data from the Zimura® (avacincaptad pegol) OPH2003 Phase 3 randomized, controlled clinical trial in geographic atrophy secondary to age-related macular degeneration.

Aldeyra Therapeutics

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Aldeyra Therapeutics Reaches Agreement with the US FDA for the Use of RASP as an Objective Sign for the Treatment of Dry Eye Disease

Lead Product(s): Reproxalap

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: U.S FDA

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement June 04, 2020

Details:

In a Phase 2a dry eye disease clinical trial, Aldeyra’s investigational RASP inhibitor reproxalap demonstrated reduction in tear RASP levels following 28 days of treatment.

Outlook Therapeutics

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Outlook Therapeutics Announces $16.0 Million Private Placement to Advance the Development of ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

Lead Product(s): Bevacizumab

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Syntone Ventures LLC

Deal Size: $16.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement May 26, 2020

Details:

The primary focus for the development and commercialization of ONS-5010 remains on the seven major global markets and to enhance the potential commercialization of ONS-5010 in an additional market with unique characteristics.

ReGenTree

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ReGenTree Announces Efficacy Results of the Neurotrophic Keratopathy Phase 3 Clinical Trial with RGN-259

Lead Product(s): Thymosin Beta-4

Therapeutic Area: Ophthalmology Product Name: Undisclosed

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 May 14, 2020

Details:

Six out of 10 patients in the RGN-259 treated group and 1 out of 8 patients in the placebo treated group achieved complete corneal healing in 4 weeks.

Ocular Therapeutix

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Ocular Therapeutix™ To Present New Data at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 Virtual Annual Meeting

Lead Product(s): Dexamethasone

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 May 11, 2020

Details:

Presentations to cover DEXTENZA for the treatment of ocular inflammation and pain following ophthalmic surgery and OTX-TIC in glaucoma.

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Find Ophthalmology Drugs in Phase III Clinical Development in UNITED STATES

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IVERIC bio

IVERIC bio Announces First Patient Dosed in Second Zimura® Phase 3 Clinical Trial

Eyenovia

Eyenovia Resumes Recruitment of Phase III CHAPERONE Study for Progressive Myopia

Outlook Therapeutics

Outlook Therapeutics Provides Clinical Update on ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

IVERIC bio

IVERIC bio Announces Positive Zimura 18 Month Data Supporting the 12 Month Efficacy Findings

Aldeyra Therapeutics

Aldeyra Therapeutics Receives Orphan Medicinal Product Designation from the European Commission for ADX-2191 Retinal Disease Program

IVERIC bio

IVERIC bio to Announce Zimura® 18 Month Data from the OPH2003 Phase 3 Clinical Trial in Geographic Atrophy Secondary to Age-Related Macular...

Aldeyra Therapeutics

Aldeyra Therapeutics Reaches Agreement with the US FDA for the Use of RASP as an Objective Sign for the Treatment of Dry Eye Disease

Outlook Therapeutics

Outlook Therapeutics Announces $16.0 Million Private Placement to Advance the Development of ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

ReGenTree

ReGenTree Announces Efficacy Results of the Neurotrophic Keratopathy Phase 3 Clinical Trial with RGN-259

Ocular Therapeutix

Ocular Therapeutix™ To Present New Data at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 Virtual Annual Meeting