IVERIC bio Inc. (NASDAQ:ISEE) has announced encouraging 18-month results from its first third phase clinical study (OPH2003) of Zimura for geographic atrophy secondary to age-associated macular degeneration (AMD).
Positive 18-month OPH2003 clinical trial results
The company’s 18-month results support previously released 12-month results from the trial. At the time, Zimura achieved the primary efficacy endpoints with significance. The reduction in the average rate of geographic atrophy growth in the 18 months was around 28.11% for the group that received 2mg of Zimura. On the other and, the sham control cohort had a reduction mean rate of 29.97% for 4mg of Zimura relative to the respective sham control cohort.
The company conducted the pre-specified primary efficacy analysis after 12 months using all the power in the study to establish a statistically significant change. As a result, the p-values for statistical analyses after 18 months are just descriptive.
Zimura showed favorable efficacy and safety after 18 months
In the study, the treatment results were seen after around six months in which there was an enhanced absolute difference in the average change in geographic atrophy. This was for either 2mg or 4mg Zimura treatment relative to the sham group at the given time points. As a result, this indicated a progressive benefit for continuous Zimura treatment. At 18 months, Zimura showed an encouraging safety profile without any reported adverse effects associated with Zimura. There were no endophthalmitis cases, and a low choroidal neovascularization rate relative to those reported in C3 inhibition.
IVERIC bio CEO and President Glenn Sblendorio indicated that they were delighted with the positive 18month data from the third phase clinical study in terms of safety and efficacy. The CEO added that the clinical study results indicated that there was continued treatment with Zimura with a good safety profile in patients with secondary GA top AMD. Glenn affirmed that this was a huge milestone for the company considering the OPH2003 study was the only clinical trial in the third phase demonstrating GA growth suppression after 18-months of treatment.