Early this morning, gene therapy focused biopharmaceutical company IVERIC bio Inc. (ISEE:NASDAQ), which focuses on the discovery and development of novel treatment options for orphan inherited retinal diseases, announced initial topline data confirming that "Zimura (avacincaptad pegol), the firm's complement factor C5 inhibitor, met its prespecified primary endpoint in reducing the rate of geographic atrophy (GA) growth in patients with dry age-related macular degeneration (AMD) in a randomized, controlled Phase 2b clinical trial."
The study enrolled 286 patients in order to assess the safety and efficacy of various doses of Zimura in patients with GA secondary to dry AMD. The company reported a reduction in the mean rate of GA growth over 12 months and noted that the overall data suggest a dose response relationship across all treatment groups. The company further advised that Zimura was generally well tolerated after 12 months of administration with no Zimura-related inflammation, nor were there any ocular serious adverse events and no cases of endophthalmitis reported in the study eye in this ongoing clinical trial.
Marco A. Zarbin, M.D., Ph.D., FACS, Professor and Chair, Institute of Ophthalmology and Visual Science, Rutgers-New Jersey Medical School, Newark, NJ stated, "IVERIC bio's unwavering commitment to science has resulted in compelling Phase 2b data in GA secondary to dry AMD, a major public health problem that has devastating effects on our patients...As a retina specialist, Zimura's impressive efficacy results and favorable safety profile observed to date in this trial indicate its potential as a future treatment for this growing patient population, which represents an urgent unmet medical need."
IVERIC bio's CEO and President Glenn P. Sblendorio commented, "This is a major milestone for IVERIC bio and a potentially significant advancement for patients with GA secondary to dry AMD who currently have no treatment options...Based on these data, we intend to explore all options for the future development of Zimura, including the possibility for collaboration opportunities, licensing and / or potentially further internal development."
IVERIC bio's Chief Medical Officer Kourous A. Rezaei, M.D., added, "Zimura's efficacy data in this clinical trial supports the potential role of C5 inhibition in GA secondary to dry AMD...C5 activation may lead to retinal cell degeneration and ultimately cell death. We believe that the combination of statistically significant efficacy results for both Zimura 2 mg and 4 mg groups compared to their respective sham controls, with the lack of Zimura induced inflammation, zero rate of endophthalmitis and observed CNV conversion rate as compared to sham in this trial may potentially differentiate Zimura. We are encouraged by these exciting results, which we look forward to presenting in more detail at upcoming medical meetings in the near future."
The company explains that "dry AMD is where thinning of the retinal pigment epithelial cells in the central portion of the retina, or the macula, develops, along with other age-related changes to the adjacent retinal and choroidal tissue layers...it is a significant cause of moderate and severe loss of central vision in older adults, affecting both eyes in the majority of patients...Geographic atrophy, the advanced stage of dry AMD, is a disease characterized by degeneration of retinal tissue leading to further loss of vision." IVERVIC points out that presently there are no U.S. FDA or European Medicines Agency approved therapies to treat dry AMD.
IVERIC bio is headquartered in New York, NY and is a gene therapy focused biopharmaceutical company focused on the discovery and development of novel treatment options for orphan inherited retinal diseases with significant unmet medical needs. The firm proclaims that "Vision is Our Mission".
IVERIC started off today with a market capitalization of about $38.7 million with approximately 41.56 million shares outstanding. ISEE shares opened nearly 100% higher today on the news at $1.85 (+$0.92, +98.92%) compared to Friday's $0.93 closing price. The stock typically trades 75,000 to 150,000 shares per day, but today has already traded more than 22 million shares between $1.58 to $1.99 per share and is presently trading at $1.87 (+$0.94, +101.08%).[NLINSERT]
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