Ophthalmology | Phase II Developments

Immunovant

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Drug Discovery Chemistry

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Immunovant Announces Positive Clinical Results from Ongoing Phase 2a Proof-of-Concept Study of IMVT-1401

Lead Product(s): IMVT-1401

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 30, 2020

Details:

65% mean reduction in total IgG was observed from baseline to end of treatment, with a pharmacodynamic (PD) response nearly identical to modeled predictions for dosing regimen tested in trial.

Eyenovia

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Eyenovia, Inc. Announces Closing of Approximately $6.0 Million Private Placement

Lead Product(s): Pilocarpine

Therapeutic Area: Ophthalmology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: National Securities Corporation

Deal Size: $6.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement March 24, 2020

Details:

The offering are expected to be used for the MicroLine and MicroPine clinical studies, to advance MicroStat’s new drug application, and for working capital & general corporate purposes.

IVERIC bio

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

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

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

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.

Ribomic

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JAPAN Japan

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RIBOMIC Enters License Agreement with AJU Pharma

Lead Product(s): RBM-007

Therapeutic Area: Ophthalmology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: AJU Pharma

Deal Size: $6.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement March 17, 2020

Details:

Upon execution of this Agreement, AJU will obtain the exclusive license to develop and sell the Product containing RBM-007 (the “Product”) in the Territory.

Nicox SA

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FRANCE France

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Nicox to Receive €15 Million and Half of the Cost of the Second NCX 470 Phase 3 Clinical Trial

Lead Product(s): NCX 470

Therapeutic Area: Ophthalmology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Ocumension Therapeutics

Deal Size: $165.0 million Upfront Cash: Undisclosed

Deal Type: Agreement March 11, 2020

Details:

Nicox will conduct both of its planned Phase 3 clinical trials, Mont Blanc and Denali, as multi-regional clinical trials in U.S. and China.

Santen Pharmaceutical

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JAPAN Japan

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Santen, Tracon discontinue development of eye drug after mid-stage trial failure

Lead Product(s): Carotuximab

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 10, 2020

Details:

The companies said DE-122, when combined with Lucentis, did not meet the trial's main goal of improving visual acuity in patients with wet AMD compared to those taking Lucentis alone.

Nicox SA

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FRANCE France

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Nicox’s Positive End-of-Phase 2 Meeting with the U.S. FDA Sets Stage for NCX 470 Phase 3 Program in Glaucoma

Lead Product(s): NCX 470

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 05, 2020

Details:

NCX 470 demonstrated both statistical non-inferiority and superiority to latanoprost, the U.S. market leader in prostaglandin analog prescriptions.

Palatin Technologies

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

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.

Ribomic

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JAPAN Japan

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RIBOMIC Announces First Injection in the Phase 2 Clinical Trial of RBM-007 (TOFU Study)

Lead Product(s): RBM-007,Aflibercept

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:

First patient has received injection in the phase 2 trial of RBM-007 for the treatment of exudative age-related macular degeneration (AMD) in the United States.

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Immunovant

Immunovant Announces Positive Clinical Results from Ongoing Phase 2a Proof-of-Concept Study of IMVT-1401

Eyenovia

Eyenovia, Inc. Announces Closing of Approximately $6.0 Million Private Placement

IVERIC bio

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

Graybug Vision

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

Ribomic

RIBOMIC Enters License Agreement with AJU Pharma

Nicox SA

Nicox to Receive €15 Million and Half of the Cost of the Second NCX 470 Phase 3 Clinical Trial

Santen Pharmaceutical

Santen, Tracon discontinue development of eye drug after mid-stage trial failure

Nicox SA

Nicox’s Positive End-of-Phase 2 Meeting with the U.S. FDA Sets Stage for NCX 470 Phase 3 Program in Glaucoma

Palatin Technologies

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

Ribomic

RIBOMIC Announces First Injection in the Phase 2 Clinical Trial of RBM-007 (TOFU Study)