Ophthalmology | Phase II Developments | UNITED STATES

Aerpio Pharmaceuticals

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Aerpio Announces Initiation of 28-Day Phase 2 Razuprotafib Glaucoma Trial

Lead Product(s): Razuprotafib

Therapeutic Area: Ophthalmology Product Name: AKB-9778

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 June 24, 2020

Details:

Aerpio Pharmaceuticals has commenced patient enrollment in its double-blind, placebo-controlled Phase 2 trial in patients with elevated intraocular pressure (IOP) associated with open angle glaucoma (OAG) or ocular hypertension (OHT).

Ocuphire Pharma

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Rexahn and Ocuphire Enter into Definitive Merger Agreement

Lead Product(s): Phentolamine

Therapeutic Area: Ophthalmology Product Name: Nyxol

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Rexahn Pharmaceuticals Inc

Deal Size: $21.1 million Upfront Cash: Undisclosed

Deal Type: Merger June 18, 2020

Details:

This merger supports Ocuphire for advancement of its late-clinical stage small molecule ophthalmic pipeline including its Nyxol® Eye Drops, a once-daily eye drop formulation of phentolamine mesylate designed to reduce pupil diameter and improve visual acuity.

Tarsus Pharmaceuticals

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Tarsus Pharmaceuticals Reports Results of the Mars study, a Phase 2a Study of the Efficacy and Safety of TP-03 to Treat Demodex Blepharitis

Lead Product(s): TP-03

Therapeutic Area: Ophthalmology Product Name: Undisclosed

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 June 15, 2020

Details:

The Mars study demonstrated that the use of TP-03 for 4 weeks was well-tolerated and showed promising efficacy in the treatment of Demodex Blepharitis with treatment effects persisting for at least 90 days.

Noveome Biotherapeutics

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Noveome Biotherapeutics Announces Positive Data for Phase 2 Clinical Trial of ST266 in Patients with Persistent Corneal Epithelial Defects

Lead Product(s): ST266

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 12, 2020

Details:

Results suggest that ST266 is consistent with pre-clinical studies in which ST266 treatment was associated with reduced inflammation, decreased neutrophil infiltration, and increased re-epithelization in a rabbit model for corneal incision and abrasion.

Adverum Biotechnologies

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Adverum Biotechnologies Announces New INFINITY Phase 2 Trial for ADVM-022 in Diabetic Macular Edema

Lead Product(s): AAV.7m8-aflibercept

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 28, 2020

Details:

The INFINITY trial will enroll approximately 33 patients and is designed to demonstrate superior control of disease activity following a single IVT injection of ADVM-022 compared to a single aflibercept injection.

Palatin Technologies

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Palatin Technologies Provides Assessment of Impact of COVID-19 Pandemic on Business Operations

Lead Product(s): PL9643

Therapeutic Area: Ophthalmology Product Name: Undisclosed

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 April 30, 2020

Details:

Dry Eye Disease Phase 2 Study Remains on Track - Data Anticipated in 4Q20.

IVERIC bio

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IVERIC bio Announces Fast Track Designation from FDA for Zimura® for the Treatment of Geographic Atrophy

Lead Product(s): Avacincaptad Pegol

Therapeutic Area: Ophthalmology Product Name: Undisclosed

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 April 03, 2020

Details:

Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in an international, multicenter, randomized, double masked, sham controlled clinical trial.

Immunovant

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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 Product Name: Undisclosed

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 Product Name: Undisclosed

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 Product Name: Undisclosed

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.

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Find Ophthalmology Drugs in Phase II Clinical Development in UNITED STATES

United States

Product Type

Companies

Aerpio Pharmaceuticals

Aerpio Announces Initiation of 28-Day Phase 2 Razuprotafib Glaucoma Trial

Ocuphire Pharma

Rexahn and Ocuphire Enter into Definitive Merger Agreement

Tarsus Pharmaceuticals

Tarsus Pharmaceuticals Reports Results of the Mars study, a Phase 2a Study of the Efficacy and Safety of TP-03 to Treat Demodex Blepharitis

Noveome Biotherapeutics

Noveome Biotherapeutics Announces Positive Data for Phase 2 Clinical Trial of ST266 in Patients with Persistent Corneal Epithelial Defects

Adverum Biotechnologies

Adverum Biotechnologies Announces New INFINITY Phase 2 Trial for ADVM-022 in Diabetic Macular Edema

Palatin Technologies

Palatin Technologies Provides Assessment of Impact of COVID-19 Pandemic on Business Operations

IVERIC bio

IVERIC bio Announces Fast Track Designation from FDA for Zimura® for the Treatment of Geographic Atrophy

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