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Details:
IZERVAY™ (avacincaptad pegol intravitreal solution), a complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Izervay
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Astellas Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2023
Details:
Izervay (avacincaptad pegol intravitreal solution) act as completent C5 inhibitor that is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Izervay
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: IVERIC bio
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2023
Details:
IZERVAY (avacincaptad pegol intravitreal solution) act as completent C5 inhibitor that is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Izervay
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 04, 2023
Details:
Through the acquisition, Astellas expands its ophthalmology pipeline through Iveric Bio's promising programs, including Zimura (avacincaptad pegol), an important program for Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD).
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Astellas Pharma
Deal Size: $5,900.0 million Upfront Cash: $5,900.0 million
Deal Type: Acquisition July 11, 2023
Details:
Through the acquisition, Astellas will expand its ophthalmology pipeline through Iveric Bio's promising programs, including Zimura (avacincaptad pegol), an important program for Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD).
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Astellas Pharma
Deal Size: $5,900.0 million Upfront Cash: $5,900.0 million
Deal Type: Acquisition April 30, 2023
Details:
Zimura (avacincaptad pegol) is a novel complement C5 protein inhibitor having the potential to decrease activity of the complement system that causes the degeneration of retinal cells and potentially slow the progression of geographic atrophy.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2023
Details:
Zimura (avacincaptad pegol) is a novel complement C5 protein inhibitor by targeting C5, ACP has the potential to decrease activity of the complement system that causes the degeneration of retinal cells and potentially slow the progression of GA.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 16, 2023
Details:
Zimura (avacincaptad pegol), is an investigational drug that has not yet been evaluated by any regulatory body for safety and efficacy. ACP is not authorized for any indication in any country.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2022
Details:
Zimura (ACP) is novel complement C5 protein inhibitor. Overactivity of the complement system and the C5 protein are suspected to play a critical role in development and growth of scarring and vision loss associated with GA secondary to AMD.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2022
Details:
Zimura (avacincaptad pegol) showed Primary Endpoint Met with 14.3% Reduction (p-value = 0.0064) in Mean Rate of Growth (Slope) in GA Area Over 12 Months Using Square Root Transformation; 17.7% Reduction (p-value = 0.0039) Using Observed GA Area
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2022
Details:
The non-dilutive financing will strengthen the balance sheet and provides financial flexibility as to fund the potential commercial launch of Zimura® (avacincaptad pegol) in geographic atrophy (GA) in the United States, subject to regulatory approval.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Hercules Capital
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing July 26, 2022
Details:
Zimura (avacincaptad pegol) is an investigational drug product and has not been approved for use anywhere globally, it is designed to target and inhibit the cleavage of complement protein C5 and the formation of its downstream fragments, C5a and C5b.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2022
Details:
As part of Iveric Bio’s lifecycle expansion plan for Zimura (avacincaptad pegol), the Company is committed to developing sustained release technologies for the treatment of age-related macular degeneration (AMD).
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: DelSiTech
Deal Size: Undisclosed Upfront Cash: $1.2 million
Deal Type: Agreement July 05, 2022
Details:
Zimura (avacincaptad pegol) is an investigational drug product and has not been approved for use anywhere globally. Zimura is designed to target and inhibit cleavage of complement protein C5 and formation of its downstream fragments, C5a and C5b.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
Details:
In GATHER2, 448 patients were randomized to receive either monthly administration of Zimura 2 mg or sham during the first 12 months of the trial, at which time the primary efficacy analysis of the mean rate of change of GA growth (slope) at 12 months will be performed.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2021
Details:
Zimura (avacincaptad pegol) is an investigational drug product and has not been approved for use anywhere globally. Zimura is designed to target and inhibit the cleavage of complement protein C5 and the formation of its downstream fragments, C5a and C5b.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2021
Details:
GATHER1 18 Month Post-Hoc Analyses Show that Zimura 2 mg Has the Potential to Have an Impact on Earlier Stages of Dry AMD Prior to Geographic Atrophy. Zimura (avacincaptad pegol) is an investigational drug product and has not been approved for use anywhere globally.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 18, 2021
Details:
Zimura met its pre-specified primary efficacy endpoint at 12 months and reached statistical significance in GATHER1, which was an international, multicenter, randomized, double masked, sham controlled clinical trial.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
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 GATHER2 or ISEE2008, in Phase 3 clinical trial for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for treatment of geographic atrophy secondary to age-related macular degeneration.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2020
Details:
IVERIC Bio announced positive 18 month results from the Company's first Phase 3 clinical trial (OPH2003) for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
IVERIC will report 18 month data from the Zimura® (avacincaptad pegol) OPH2003 Phase 3 randomized, controlled clinical trial in geographic atrophy secondary to age-related macular degeneration.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Zimura
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 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.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 03, 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.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2020
Details:
This 2nd pivotal trial will be an international, sham controlled clinical trial enrolling 400 patients to be randomized to receive monthly administration of Zimura 2 mg or sham.
Lead Product(s): Avacincaptad Pegol
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2020
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