Find Ophthalmology Drugs in Phase II Clinical Development

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            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.

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            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).

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            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.

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            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.

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            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.

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            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.

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            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.

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            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.

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            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.

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            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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