"It is positive that even the higher dose was well tolerated by the treated patients. After the planned safety evaluation, we are now proceeding with the study and, provided that the safety profile continues to be good, we intend to apply for permission to go up further in dose(s). However, the total number of patients in the study - up to 16 patients - will not increase unless there are clinical results that justify it", says Anna Frostegård, Chief Scientific and Medical Officer at
To date, eight patients have completed the treatment, of which six patients have been treated with the lower dose level of 2 mg/day and two patients with the higher dose of 4 mg/day during five days.
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About the Phase 2 study
Annexin's Phase 2 clinical trial includes patients who have recently received their RVO diagnosis, but who have not been treated with the standard anti-VEGF therapy. It is an open-label study in which patients receive ANXV followed by anti-VEGF (if needed) and followed for up to four months with examinations to evaluate safety, tolerability and any signals of efficacy related to ANXV. The company plans to include up to 16 patients, of which six patients have been treated at the lower dose level, 2 mg/day, and up to ten patients are intended to be treated at the higher dose levels.
About retinal vein occlusion (RVO)
RVO is a vascular disease of the eye in which blood flow in the veins of the retina is blocked. The disease often leads to severe visual impairment or blindness and a need for long-term treatment. The treatments for RVO that are available today are injected directly into the eye, usually monthly, and have no effect on the blockage of blood vessels that causes RVO. According to a 2021 report by
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