Annexin Pharmaceuticals AB announced that 6 out of 8 patients with the eye disease retinal vein occlusion (RVO) receiving the investigational drug candidate ANXV in the Phase 2a/proof-of-concept study and who have been followed for 3 months or longer show durable benefits while not requiring multiple anti-VEGF injections. To date, a total of 11 patients with newly diagnosed RVO have been treated with ANXV at three different dose levels and no limiting adverse events have been reported. In august 2023, Annexin reported about 2 out of 4 treated patients showing promising signals of effect according to an independent analysis.

These two patients have remained stable in visual acuity and treated with only one anti-VEGF injection during at least 12 months. The company now reports that an additional 4 patients who have been followed for at least 3 months after the ANXV treatment show an improvement, or no worsening, of their visual acuity (BCVA) and in several cases a reduced swelling of the retina. These patients have been deemed to require no or a single injection of anti-VEGF and this includes 2 patients with central retinal vein occlusion ("CRVO") who would typically require more frequent treatments.

The decision to administer anti-VEGF is based on the presence of swelling of the retina and poor visual acuity and is taken by the patient's treating ophthalmologist. The follow-up period for three additional patients is not yet over three months and therefore they have not yet been evaluated for visual acuity and retinal swelling. Since the placebo group in the study was removed, the patient recruitment rate has increased and so far 11 patients have been enrolled, 10 have been fully treated and 8 have been evaluated for 3 months or longer.

If the safety and signal of effect data do not motivate further patient enrolments in the study, the company expects to have evaluated the data from the study's last patient by mid-2024. About the study. Annexin's phase 2a/proof-of theconcept study includes patients who have recently suffered RVO, but have not been treated with the standard anti-VEGF therapy.

After the protocol update, the study is an open-label study where patients receive the investigational new drug ANXV followed by anti-VEGF (as needed) and are followed up to four months with examinations to assess safety, tolerability and any signals of effect that may be related to ANXV. The company plans to include up to 16 patients at three different dose levels. The study is conducted at 7 different eye clinics in the US.

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 the need for long-term treatment. 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.

According to a 2021 report by Transparency Market Research, the value of the RVO market in 2025 is estimated to reach approximately USD 20 billion, and it is expected to grow by approximately 7% annually over the next 10 years.