Iveric Bio Shares Shoot Higher Following Positive Top-line Data From Late-Stage Geographic Atrophy Study

Iveric Bio ISEE announced positive topline results from the second Phase 3 clinical trial of Zimura (avacincaptad pegol) for the treatment of geographic atrophy (GA).

Zimura is a novel complement C5 protein inhibitor. Overactivity of the complement system and the C5 protein are suspected to play a critical role in the development and growth of scarring and vision loss associated with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). 

Zimura evaluated in the GATHER2 study, the second Phase 3 clinical trial for patients with Geographic Atrophy (GA).

The study met its pre-specified primary endpoint of mean rate of growth (slope) in GA area at 12 months with statistical significance and a favorable safety profile.

The GATHER2 study observed no events of endophthalmitis, no intraocular inflammation events, and no ischemic optic neuropathy events through month twelve. However the most frequently reported ocular adverse events were related to the injection procedure.

Glenn P. Sblendorio, Chief Executive Officer, commented: "We are thrilled to see for the first time an investigational therapy with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials. The results from GATHER1 and GATHER2 and our Special Protocol Assessment with the FDA provide the basis for an NDA.”

The company is planning to submit a New Drug Application (NDA) to the FDA by the end of the First Quarter in the year 2023.

The Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients.

Price Action : Iveric shares are trading around 36 percent higher at $12.83 on Tuesday at the time of publication.