Ophthalmology | Phase III Developments | UNITED STATES

IVERIC bio

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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.

Outlook Therapeutics

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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.

Eyenovia

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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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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.

Aldeyra Therapeutics

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Aldeyra Therapeutics Announces New Drug Application (NDA) Development Plans for 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: 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.

Outlook Therapeutics

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Outlook Therapeutics Completes Patient Enrollment for NORSE 2 Study of Lytenava

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.

Apellis Pharmaceuticals

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Apellis Completes Enrollment in Two Phase 3 Studies of the Targeted C3 Therapy, Pegcetacoplan, in Patients with Geographic Atrophy (GA)

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.

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.

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).

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.

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IVERIC bio

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

Outlook Therapeutics

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

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

Aldeyra Therapeutics

Aldeyra Therapeutics Announces New Drug Application (NDA) Development Plans for Dry Eye Disease

Outlook Therapeutics

Outlook Therapeutics Completes Patient Enrollment for NORSE 2 Study of Lytenava

Apellis Pharmaceuticals

Apellis Completes Enrollment in Two Phase 3 Studies of the Targeted C3 Therapy, Pegcetacoplan, in Patients with Geographic Atrophy (GA)

Eyenovia

Eyenovia Resumes Recruitment of Phase III CHAPERONE Study for Progressive Myopia

IVERIC bio

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

Outlook Therapeutics

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