By a News Reporter-Staff News Editor at Clinical Trials Week -- Ophthotech Corporation (NASDAQ: OPHT) announced the initiation of an open-label Phase 2a clinical trial of Zimura® (avacincaptad pegol), the Company's complement factor C5 inhibitor, in patients with wet age-related macular degeneration (AMD). Zimura will be administered in combination with Lucentis® (ranibizumab), an anti-vascular endothelial growth factor (anti-VEGF), in patients with wet AMD who have not been previously treated with anti-VEGF drugs. A range of Zimura dosing regimens will be assessed. Clinical trial sites have been identified and activated (see also Ophthotech Corporation).
"We believe that supplementing anti-VEGF therapy with a complement inhibitor such as Zimura may have the potential to further enhance the efficacy of anti-VEGF monotherapy in wet AMD," stated Kourous A. Rezaei, M.D., Senior Vice President of Medical Strategy. "Our earlier Phase 1/2a clinical trial assessing Zimura in combination with Lucentis, while small and uncontrolled, showed intriguing results. A recent peer-reviewed publication from the Journal of Clinical Investigation from Scripps Research Institute provided further support that anti-VEGF therapy upregulates complement activation and therefore that complement inhibition during anti-VEGF therapy may have therapeutic merit. These findings establish a foundation to pursue further development of Zimura in wet AMD."
"We are excited to move the Company forward with opportunities consistent with our overall strategy to develop Zimura for both orphan diseases and larger indications in the back of the eye, such as age-related retinal diseases," stated Glenn P. Sblendorio, Chief Executive Officer and President of Ophthotech.
The Company also announced that it remains on track to initiate two additional Zimura clinical trials before the end of the year. The Company's strategy in orphan indications will be led by a randomized, controlled clinical trial to assess Zimura monotherapy in Stargardt disease, a devastating orphan retinal disease-causing vision loss during childhood or adolescence. The other trial will be an open-label Phase 2a clinical trial evaluating Zimura in combination with anti-VEGF therapy for idiopathic polypoidal choroidal vasculopathy (IPCV), an age-related eye disease. Ophthotech is also planning a Phase 2a clinical trial of Zimura monotherapy for intermediate/posterior non-infectious uveitis, an orphan inflammatory disease of the back of the eye. This trial is planned to initiate in 2018.
Keywords for this news article include: Therapy, Clinical Research, Ophthotech Corporation, Clinical Trials and Studies, Eye Diseases and Conditions, Retinal Diseases and Conditions.
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