Policy & Regulation
First Patient Dosed in Second Zimura Phase 3 Clinical Trial for the Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration
2 July 2020 - - The first patient has been dosed in GATHER2, also known as ISEE2008, the second Phase 3 clinical trial for Zimura (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy secondary to age-related macular degeneration, US-based Iveric bio, Inc. (NASDAQ: ISEE) said.

The company announced previously that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in GATHER1, also known as OPH2003, the first Phase 3 clinical trial for Zimura for the treatment of GA secondary to AMD.

There are no US Food and Drug Administration or European Medicines Agency approved treatments available for patients with GA secondary to AMD.

In the GATHER2 clinical trial, approximately 400 patients will be 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 at 12 months will be performed.

If the 12 month results are positive, the company plans to file an application with the US Food and Drug Administration and the European Medicines Agency for marketing approval of Zimura for GA following receipt of that data.

At month 12, the company plans to re-randomize patients in the Zimura 2 mg arm to receive either monthly or every other month administration of Zimura 2 mg.

The final evaluation will take place at month 24.

Age-related macular degeneration is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision.

As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue.

Geographic atrophy, the advanced stage of AMD, leads to further irreversible loss of vision in these patients.

There are currently no US Food and Drug Administration or European Medicines Agency approved treatment options available for patients with geographic atrophy.

Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of AMD.

Zimura is designed to inhibit complement factor C5 cleavage into C5a and C5b.

By inhibiting the formation of complement C5 terminal fragments, Zimura may decrease the activation of inflammasomes and the formation of membrane attack complex.

This mechanism of action could potentially prevent or slow down the degeneration of retinal pigment epithelial cells and slow down the progression of GA.

Iveric bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs.

The company is currently developing both therapeutic product candidates for age-related retinal diseases and gene therapy product candidates for orphan inherited retinal diseases.
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