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Find Ophthalmology Drugs in Phase II Clinical Development in UNITED STATES

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            Lead Product(s): AR-15512

            Therapeutic Area: Ophthalmology Product Name: AVX012

            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 October 29, 2020

            Details:

            The COMET-1 trial is a randomized, double-masked, vehicle-controlled trial evaluating the efficacy and safety of AR-15512 (TRPM8 agonist) in patients with dry eye disease. AR-15512 is a TRPM8 agonist for the treatment of patients with dry eye disease.

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            Lead Product(s): Ciclosporin

            Therapeutic Area: Ophthalmology Product Name: OTX-CSI

            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 October 08, 2020

            Details:

            Subjects treated with OTX-CSI demonstrated an improvement in signs of DED and an improvement in symptoms of Dry Eye Disease. OTX-CSI is a cyclosporine intracanalicular insert for the treatment of dry eye disease.

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            Lead Product(s): Ciclosporin

            Therapeutic Area: Ophthalmology Product Name: OTX-CSI

            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 29, 2020

            Details:

            The Phase 2 clinical trial is a U.S.-based, randomized, masked, multi-center trial evaluating two different formulations of OTX-CSI with vehicle insert in approximately 105 subjects who will be followed for a period of 16 weeks.

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            Lead Product(s): Risuteganib

            Therapeutic Area: Ophthalmology Product Name: Luminate

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Bausch Health

            Deal Size: $50.0 million Upfront Cash: $10.0 million

            Deal Type: Agreement September 21, 2020

            Details:

            The agreement provides Bausch with global rights for risuteganib, Allegro's lead investigational compound in retina, including Other ophthalmology assets such as Allegro's ALG-1007, a topical integrin regulator under investigation for the treatment of dry eye disease.

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Ophthalmology Product Name: APL-2

            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 21, 2020

            Details:

            This new analysis of the FILLY study demonstrates that pegcetacoplan impacts the progression of nascent GA,1,2 the earlier stage of disease that precedes atrophy, in areas of the retina outside of GA lesions.

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            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 September 15, 2020

            Details:

            The study is designed to evaluate the safety and efficacy of a topical ocular formulation of razuprotafib in approximately 195 patients followed over a 28-day period, and patients must undergo a 28-day washout prior to randomization.

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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): 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): 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): 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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