Iveric bio Announces Fast Track Designation From FDA for Zimura for Treatment of Geographic Atrophy Secondary to Dry AMD
Iveric bio announced that the FDA has granted Fast Track designation to Zimura (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).
Currently, there is no FDA or EMA approved treatment option available for patients with GA secondary to dry AMD.
“With no treatment options available for patients with geographic atrophy secondary to dry age-related macular degeneration the FDA’s Fast Track designation recognizes the potential of Zimura to address this unmet medical need,” Glenn P. Sblendorio, Chief Executive Officer and President of Iveric bio, said in a company news release. “Should the positive results from our initial Zimura pivotal clinical trial be confirmed by our second pivotal clinical trial, we believe this important designation may help expedite the registration of Zimura as a treatment option for our patients. We look forward to working closely with the FDA.”
On October 28, 2019, the company announced that Zimura met its prespecified primary efficacy endpoint and reached statistical significance in an international, multicenter, randomized, double masked, sham controlled clinical trial in GA secondary to dry AMD, referred to as the OPH2003 trial. Zimura was generally well tolerated after 12 months of administration. Iveric bio provided further details supporting the positive results from this pivotal trial in its Annual Report on Form 10-K filed on February 27, 2020.
The FDA created the Fast Track process to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases or conditions, which have the potential to fill an unmet medical need. Fast Track designation offers important benefits, including frequent interactions with the FDA and the potential eligibility for Rolling Submission and Priority Review of a New Drug Application, if relevant criteria are met.