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    Find Ophthalmology Drugs in Phase II Clinical Development in UNITED STATES

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              IVERIC bio

              • Development Update

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              UNITED STATES United States

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              Drug Discovery Chemistry

              Participation Not Confirmed

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              IVERIC bio Provides Update on the Initiation of the Second Pivotal Clinical Trial Enrollment for Zimura

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              Lead Product(s): Avacincaptad Pegol

              Therapeutic Area: Ophthalmology

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 18, 2020

              Details:

              Company has decided to delay the initiation of enrollment of patients in the second pivotal clinical trial for Zimura® (avacincaptad pegol) for the treatment of geographic atrophy.

              Graybug Vision

              • Development Update

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              Graybug Vision Concludes Patient Enrollment in its Phase 2b Clinical Trial of GB-102

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              Lead Product(s): Sunitinib Malate

              Therapeutic Area: Ophthalmology

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 18, 2020

              Details:

              A limited interim safety analysis performed in February 2020 supports Graybug’s intention to take the 1 mg dose forward for further exploration in clinical trials.

              Palatin Technologies

              • Development Update

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              Palatin Technologies, Inc. Announces First Patient Enrolled in Dry Eye Disease Phase 2 Clinical Trial with PL9643

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              Lead Product(s): PL9643

              Therapeutic Area: Ophthalmology

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 19, 2020

              Details:

              The Phase 2 study is evaluating the efficacy and safety of PL9643 ophthalmic solution (topical eye drops) compared to placebo for the treatment of the signs and symptoms of dry eye.

              KalVista Pharmaceuticals

              • Deals

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              KalVista Pharma Provides Update on Diabetic Macular Edema Programs

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              Lead Product(s): KVD001

              Therapeutic Area: Ophthalmology

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Merck

              Deal Size: $761.0 million Upfront Cash: $37.0 million

              Deal Type: Agreement February 10, 2020

              Details:

              With the option expiration, KalVista has no obligations to Merck, and retains full ownership of all of its DME intellectual property in addition to its oral hereditary angioedema (HAE) portfolio.

              Alkahest

              • Development Update

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              Alkahest Announces Initiation of Phase 2b Clinical Trial of AKST4290

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              Lead Product(s): AKST4290

              Therapeutic Area: Ophthalmology

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 10, 2020

              Details:

              The company has dosed the first subject in AKST4290-205, which will assess the effects of AKST4290 on visual acuity with loading doses of anti-VEGF in treatment-naïve neovascular AMD patients.

              Kodiak Sciences

              • Development Update

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              Kodiak Sciences Announces Safety, Efficacy and Durability Data

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              Lead Product(s): KSI-301

              Therapeutic Area: Ophthalmology

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 09, 2020

              Details:

              Encouraging safety profile continues with zero cases of intraocular inflammation after 420 doses in 130 patients including Strong anti-VEGF efficacy with extended dosing intervals.

              Kodiak Sciences

              • Development Update

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              Kodiak Sciences to Present KSI-301 Phase 1b Clinical Study Data

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              Lead Product(s): KSI-301

              Therapeutic Area: Ophthalmology

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 05, 2020

              Details:

              Later this year Kodiak Sciences is planning to initiate four additional pivotal clinical studies of KSI-301 with the objective to file an initial BLA in 2022.

              Apexian Pharmaceuticals

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              Ocuphire Pharma Announces In-License of Phase 2 Oral Small Molecule Drug Candidate for Diabetic Retinopathy and Diabetic Macular Edema from ...

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              Lead Product(s): APX3330

              Therapeutic Area: Ophthalmology

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Ocuphire Pharma

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Licensing Agreement January 22, 2020

              Details:

              Under the terms and conditions of the deal, Ocuphire earns an exclusive worldwide sublicense to Apexian’s Ref-1 Inhibitor program, including its lead drug candidate APX3330.

              Neuroptika

              • Development Update

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              Neuroptika Announces Enrollment Of First Patient In Phase 2 Clinical Trial For Dry Eye Disease

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              Lead Product(s): NRO-1

              Therapeutic Area: Ophthalmology

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 16, 2020

              Details:

              The Phase 2 clinical trial is a multicenter, randomized, double-masked, vehicle-controlled clinical trial that will evaluate the safety and efficacy of NRO-1 in patients with dry eye disease.

              IVERIC bio

              • Development Update

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              UNITED STATES United States

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              Drug Discovery Chemistry

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              IVERIC bio Announces Design for Second Pivotal Clinical Trial of Zimura® in Geographic Atrophy Secondary to Dry Age-Related Macular Degener...

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              Lead Product(s): Avacincaptad Pegol

              Therapeutic Area: Ophthalmology

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 13, 2020

              Details:

              This 2nd pivotal trial will be an international, sham controlled clinical trial enrolling 400 patients to be randomized to receive monthly administration of Zimura 2 mg or sham.

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