Find Ophthalmology Drugs in Phase II Clinical Development in UNITED STATES

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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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            Lead Product(s): Dexamethasone

            Therapeutic Area: Ophthalmology Product Name: AR-1105

            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 July 27, 2020

            Details:

            The objective of the Phase 2 clinical trial was to evaluate two formulations of AR-1105, clinical formulation #1 (CF-1) and clinical formulation #2 (CF-2) with different steroid release profiles.

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            Lead Product(s): Ngm621

            Therapeutic Area: Ophthalmology Product Name: NGM621

            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 July 27, 2020

            Details:

            Multicenter, randomized, double-masked, sham-controlled study will evaluate safety and efficacy of intravitreal injections of NGM621 every four or eight weeks for 48 weeks.

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            Lead Product(s): Cibinetide

            Therapeutic Area: Ophthalmology Product Name: ARA 290

            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 July 21, 2020

            Details:

            Cibinetide is a first-in-class synthetic peptide designed to activate innate repair mechanisms in the setting of tissue injury as a result of the inflammatory cascade.

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            Lead Product(s): PL9643

            Therapeutic Area: Ophthalmology Product Name: PL9643

            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 July 08, 2020

            Details:

            After pausing patient recruitment to ensure patient safety during the initial phases of the COVID-19 pandemic, Palatin has commenced patient recruitment in its PL9643 Phase 2 clinical study in subjects with dry eye disease.

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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 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).

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            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.

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