Ophthalmology | Phase III Developments

Eyenovia

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United States

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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.

NTC S.r.l.

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ITALY Italy

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NTC Grants License and Distribution Rights in Israel to Taro Pharmaceutical Industries

Lead Product(s): Levofloxacin,Dexamethasone

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Taro Pharmaceutical Industries Ltd.

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement June 17, 2020

Details:

NTC Srl has granted exclusive license and distribution rights to one of its R&D products to Taro Pharmaceutical. The product combines a quinolone antibiotic with an anti-inflammatory steroid in eye drops intended to provide an appropriate treatment for post-cataract surgery.

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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United States

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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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United States

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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.

Nicox SA

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FRANCE France

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Nicox Initiates First Phase 3 Trial of NCX 470 in Glaucoma

Lead Product(s): NCX 470

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 02, 2020

Details:

The Mont Blanc trial is a multi-regional, double-masked, adaptive design trial evaluating the efficacy and safety of NCX 470 ophthalmic solution, 0.065% and 0.1% compared to latanoprost ophthalmic solution, 0.005% in patients with open-angle glaucoma or ocular hypertension.

Outlook Therapeutics

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United States

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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.

Samsung Bioepis

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Korea, Republic Of

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Samsung Bioepis Phase 3 Trial of Ranibizumab Biosimilar Candidate, SB11 to Treat Namd Meets Primary Endpoints

Lead Product(s): Ranibizumab

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 18, 2020

Details:

In a Phase 3 study, SB11 demonstrated equivalent efficacy in terms of change in best corrected visual activity (BCVA) at Week 8 and central subfield thickness (CST) at Week 4 to reference ranibizumab LUCENTIS®i in patients with neovascular age-related macular degeneration.

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Find Ophthalmology Drugs in Phase III Clinical Development

Phase III

Product Type

Companies

Eyenovia

Eyenovia Resumes Recruitment of Phase III CHAPERONE Study for Progressive Myopia

NTC S.r.l.

NTC Grants License and Distribution Rights in Israel to Taro Pharmaceutical Industries

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

Nicox SA

Nicox Initiates First Phase 3 Trial of NCX 470 in Glaucoma

Outlook Therapeutics

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

Samsung Bioepis

Samsung Bioepis Phase 3 Trial of Ranibizumab Biosimilar Candidate, SB11 to Treat Namd Meets Primary Endpoints