Coronavirus Delays Pivotal Retinal Trials

Iveric bio and ProQR announce pauses.


Both Iveric bio and ProQR have paused pivotal trials for retinal disease because of the coronavirus outbreak. Iveric bio has decided to delay the initiation of enrollment of patients in the second pivotal clinical trial for Zimura (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to dry AMD.

"In light of the COVID-19 pandemic and out of an abundance of caution for the safety and well-being of our elderly patients and participating physicians and their staffs, we have decided to delay the initiation of enrollment in our second pivotal trial of Zimura in geographic atrophy secondary to dry AMD, the ISEE2008 trial, which was on track to begin this month," stated Glenn P. Sblendorio, CEO and President of Iveric bio, in a news release. "It is critically important that we heed the warnings from the US Centers for Disease Control, World Health Organization and national, state and local governments during this time of uncertainty. We will continue to closely monitor the situation in the United States and abroad to determine when enrollment should begin."

In addition, ProQR is pausing all of its clinical trials, including those for Usher syndrome, Leber congenital amaurosis 10, and autosomal-dominant retinitis pigmentosa. This includes the ILLUMINATE pivotal trial of sepofarsen for Leber congenital amaurosis 10. ProQR is implementing mitigation procedures that support a rapid ramp-up in enrollment as soon as the disruption resolves, including additional patient identification activities and documentation for additional site activations, while prioritizing the safety of trial participants and healthcare providers. For the trials of QR-421a (Usher syndrome) and QR-1123 (autosomal-dominant retinitis pigmentosa), patients have already been identified for the next dose cohorts and the company expects to begin dosing as soon as practical after clinical sites are ready and able to do so. The company currently does not believe that its supply chain will be affected. The ProQR pipeline focusses on severe eye diseases that have limited treatment options. All of the medicines are RNA therapies and target the underlying cause in the diseases.