Ophthalmology | Phase II Developments

Orasis Pharmaceuticals

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ISRAEL Israel

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Orasis Raises $30 Million to Advance the Clinical Development of Novel Treatment for Presbyopia

Lead Product(s): CSF-1

Therapeutic Area: Ophthalmology Product Name: PresbiDrops

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Bluestem Capital

Deal Size: $30.0 million Upfront Cash: Undisclosed

Deal Type: Series C Financing September 10, 2020

Details:

Proceeds from the financing will be used to advance Orasis’ lead eye drop candidate for the treatment of presbyopia symptoms through completion of its Phase 3 clinical trials.

Regenxbio

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United States

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Clearside Biomedical’s Licensing Partner REGENXBIO Doses First Patient in its Phase 2 Gene Therapy Trial Using SCS Microinjector® for Sup...

Lead Product(s): Rgx-314

Therapeutic Area: Ophthalmology Product Name: RGX-314

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

Partner/Sponsor/Collaborator: Regenxbio

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 09, 2020

Details:

REGENXBIO has dosed the first patient in its Phase 2 clinical trial to evaluate the suprachoroidal delivery of RGX-314, an adeno-associated virus (AAV) gene therapy, using Clearside’s SCS Microinjector® for the treatment of wet age-related macular degeneration (wet AMD).

Boehringer Ingelheim GmbH

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GERMANY Germany

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Boehringer Ingelheim Discontinues Development of BI 467335 for Diabetic Retinopathy

Lead Product(s): BI 1467335

Therapeutic Area: Ophthalmology Product Name: BI 1467335

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 September 07, 2020

Details:

Boehringer Ingelheim decided not to further develop BI 1467335 in this indication based on the lack of a clear efficacy signal and risk of dose dependent drug interactions of the compound in NPDR patients identified in another Phase I study.

Oxurion NV

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BELGIUM Belgium

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Oxurion NV Reports First Patient Dosed in Phase 2 Study Evaluating THR-149 for Treatment of Diabetic Macular Edema (DME)

Lead Product(s): THR-149

Therapeutic Area: Ophthalmology Product Name: THR-149

Highest Development Status: Phase II Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 01, 2020

Details:

First patient has been dosed in its two-part Phase 2 study (“KALAHARI”) evaluating THR-149 for the treatment of DME. THR-149 acts through inhibition of the Plasma Kallikrein-Kinin (PKaI-Kinin) system.

Bicycle Therapeutics

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United Kingdom

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Bicycle Therapeutics Dosed First Patient in Oxurion’s Phase II Trial Using a Novel Bicycle®-based Plasma Kallikrein Inhibitor for DME

Lead Product(s): THR-149

Therapeutic Area: Ophthalmology Product Name: THR-149

Highest Development Status: Phase II Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 01, 2020

Details:

The Phase II trial, named KALAHARI, is expected to include approximately 122 patients with central involved DME who do not respond adequately to anti-VEGF and will be comprised of two parts.

Regenxbio

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REGENXBIO Announces FDA Clearance of IND for Phase II Trial of RGX-314 for Diabetic Retinopathy Using Suprachoroidal Delivery

Lead Product(s): Rgx-314

Therapeutic Area: Ophthalmology Product Name: RGX-314

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 August 25, 2020

Details:

Company declared clearance of the Investigational New Drug (IND) application by the U.S. FDA to evaluate the suprachoroidal delivery of RGX-314 in patients with diabetic retinopathy. The IND is active, and REGENXBIO plans to begin dosing patients in a Phase II trial, ALTITUDE.

Opthea

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Australia

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Opthea Completes Successful Meetings with FDA and EMA for OPT-302 Phase 3 Clinical Program in Wet AMD

Lead Product(s): OPT-302,Ranibizumab

Therapeutic Area: Ophthalmology Product Name: OPT-302

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 August 21, 2020

Details:

The outcome of the meetings supports the progression of OPT-302 into Phase 3 and pre-commercial development. The company is on-track to initiate Phase 3 trials in early 2021.

Neuroptika

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United States

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Neuroptika Completes Enrollment In Phase 2 Clinical Trial For Dry Eye Disease

Lead Product(s): NRO-1

Therapeutic Area: Ophthalmology Product Name: NRO-1

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 August 17, 2020

Details:

NRO-1 is a novel therapeutic with the potential to regenerate corneal nerves in ophthalmic diseases. The Phase 2 study is a multicenter, randomized, double-masked, vehicle-controlled trial that evaluates the safety and efficacy of NRO-1 in patients with dry eye disease.

Gyroscope Therapeutics

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United Kingdom

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Gyroscope Therapeutics Starts Phase II Programme Evaluating Its Gene Therapy, GT005, for Dry Age-Related Macular Degeneration

Lead Product(s): GT005

Therapeutic Area: Ophthalmology Product Name: GT005

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 August 13, 2020

Details:

First patient dosed in Phase II EXPLORE trial evaluating GT005 in people with geographic atrophy secondary to dry AMD with a mutation in the Complement Factor I gene.

IACTA PHARMACEUTICALS

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Ophthalmology Pharmaceutical and IACTA Pharmaceuticals Sign New Licensing Agreement for Dry Eye Treatment

Lead Product(s): IC 265

Therapeutic Area: Ophthalmology Product Name: IC 265

Highest Development Status: Phase II Product Type: Undisclosed

Partner/Sponsor/Collaborator: Ophthalmology Pharmaceutical

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 28, 2020

Details:

The exclusive license is for ophthalmic indications in China and other countries of Southeast Asia. The agreement will accelerate the development of IC 265 and IC 270 in both China and the U.S.

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Find Ophthalmology Drugs in Phase II Clinical Development

Phase II

Product Type

Companies

Orasis Pharmaceuticals

Orasis Raises $30 Million to Advance the Clinical Development of Novel Treatment for Presbyopia

Regenxbio

Clearside Biomedical’s Licensing Partner REGENXBIO Doses First Patient in its Phase 2 Gene Therapy Trial Using SCS Microinjector® for Sup...

Boehringer Ingelheim GmbH

Boehringer Ingelheim Discontinues Development of BI 467335 for Diabetic Retinopathy

Oxurion NV

Oxurion NV Reports First Patient Dosed in Phase 2 Study Evaluating THR-149 for Treatment of Diabetic Macular Edema (DME)

Bicycle Therapeutics

Bicycle Therapeutics Dosed First Patient in Oxurion’s Phase II Trial Using a Novel Bicycle®-based Plasma Kallikrein Inhibitor for DME

Regenxbio

REGENXBIO Announces FDA Clearance of IND for Phase II Trial of RGX-314 for Diabetic Retinopathy Using Suprachoroidal Delivery

Opthea

Opthea Completes Successful Meetings with FDA and EMA for OPT-302 Phase 3 Clinical Program in Wet AMD

Neuroptika

Neuroptika Completes Enrollment In Phase 2 Clinical Trial For Dry Eye Disease

Gyroscope Therapeutics

Gyroscope Therapeutics Starts Phase II Programme Evaluating Its Gene Therapy, GT005, for Dry Age-Related Macular Degeneration

IACTA PHARMACEUTICALS

Ophthalmology Pharmaceutical and IACTA Pharmaceuticals Sign New Licensing Agreement for Dry Eye Treatment