What happened
Shares of Iveric Bio (ISEE) were skyrocketing 85.9% this week as of the market close on Thursday, according to data provided by S&P Global Market Intelligence. The big gain came after the company announced positive topline results on Tuesday from a late-stage clinical study evaluating Zimura in treating geographic atrophy, the advanced stage of age-related macular degeneration (AMD).
So what
Iveric reported that its phase 3 Gather2 study of Zimura met the prespecified primary endpoint of mean rate of growth in geographic atrophy area at 12 months. The experimental drug achieved a statistically significant level of improvement, compared to the control group in the study.
The safety profile of Zimura in the clinical trial was also promising. Iveric stated that no events of endophthalmitis (inflammation of tissues or fluids inside the eyeball), intraocular inflammation, or ischemic optic neuropathy (loss of vision due to the interruption of optic nerve blood flow) occurred. The most frequently reported adverse events related to the injection of the drug.
It's understandable why the biotech stock is jumping so much this week after these results. Zimura is Iveric's lead pipeline candidate. The company doesn't have any other products on the market. Also, there currently aren't any approved drugs in the U.S. or Europe for treating patients with geographic atrophy.
Now what
Iveric Bio CEO Glenn Sblendorio said that the company plans to use the results from the Gather2 study and the previous phase 3 Gather1 study to complete a New Drug Application (NDA). The company hopes to submit this NDA to the U.S. Food and Drug Administration by the end of the first quarter of 2023.