Annexin Pharmaceuticals has been given the go-ahead by FDA to start the planned phase 2clinical trial with the drug candidate ANXV in patients with retinal vein occlusion (RVO). This first study with ANXV in patients aims to investigate safety, tolerability and efficacy related to vision and retinal function of RVO patients. The study is a placebo-controlled, multiple-dose trial involving approximately 20 patients at 6-8 eye clinics in the U.S.  The overall results of the study are expected during the 4th quarter of 2022.

RVO is a vascular disease of the eye where blood flow in the retinal veins is blocked. The disease can affect anyone and can lead to acute or progressively increasing blindness. According to a report by Transparency Market Research 2021, the value of the market for RVO in 2025 is estimated to reach USD 20 billion, and is expected to grow by approximately 7% annually the next 10 years.

The treatments for RVO that are available are injected directly into the eye, usually monthly, and have no effect on the blockage of blood vessels that causes RVO.  ANXV is considered to have the potential to be a real breakthrough in the treatment of the disease because the drug candidate has the potential to directly affect the blockage, the swelling of the retina and on the inflammatory reactions that make vision loss worse. ANXV is given intravenously for a short period of time.