IVERIC bio Inc (NASDAQ:ISEE) has had consistent success in the development of treatments addressing age-related and retinal diseases. Zimura® (avacincaptad pegol) is one of the company’s treatment candidates. The novel complement C5 inhibitor, which was in Phase 3, Clinical has demonstrated positive results. Thus it could be a reliable treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Zimura did not only reach statistical significance in GATHER1 but it also met its pre-specified primary efficacy endpoint by the end of the 12 months. It had tolerability throughout the clinical trial.
GATHER1 is currently the Only Phase 3 Clinical Trial Showing Early Suppression of GA Growth
The GATHER1 clinical trial results have since been published in the Journal of the American Academy of Ophthalmology. According to the lead author of the trial Glenn Jaffe, the published data is an accomplishment both for the company and Zimura.
GA does not have any approved treatment as of today. The absence of such a treatment represents an area of an urgent unmet medical need. This is a major concern for public health in its endeavor to take care of the aging population.
Nonetheless, Jaffe explains with the Phase 3 results of Zimura; there could be some light at the end of the tunnel. It also turns out that the results are the first to show signs of suppression of GA growth.
GATHER2 is Currently Underway to Evaluate Further the Efficacy of Zimura
Commenting on the results from GATHER1, Chief Medical Officer of IVERIC bio, Kourous A. Rezaei explained, “We are privileged to have the positive results of the Zimura GATHER1 clinical trial… the highly-respected and peer-review publication of the American Academy of Ophthalmology..’’
Its clinical data has increased the enthusiasm for further evaluation of Zimura in a GATHER 2 trial. Glenn P. Sblendorio, the CEO of IVERIC bio, says they will be enrolling approximately 400 patients. Each of them will receive either 2 mg of Zimura or sham administered monthly for the first 12 months of the trial. If necessary, the patients will still be re-randomized at month 12 before final evaluation at month 24.