Annexin Pharmaceuticals AB announced that the last patient has been treated with the investigational new drug ANXV in the Phase 2a study that included a total of 15 patients with the eye disease retinal vein occlusion (RVO). Top-line data is planned to be presented in the summer of 2024. In terms of signals of effect and based on currently available information, 8 out of 10 patients followed for three months have shown improvement or no worsening of the disease, and they have either required no, or only one anti-VEGF injection (standard therapy).

No limiting safety or tolerability events associated with the ANXV treatment have been reported at any investigated dose level to date. A total of 15 patients have received ANXV, of which 6 patients have been administered 2 mg, 3 patients 4mg and 6 patients 6 mg. A recent review of available safety and tolerability data from the 6 patients who received 6 mg ANXV and were followed 10 days after receiving the last dose of ANXV did not reveal any findings of concern.

In terms of signals of effects 8 out of 10 patients, where information is available for at least three months after the treatment, data have shown an improvement or no worsening of their visual acuity (BCVA) and in several cases a reduced swelling of the retina with no or only one dose of anti-VEGF. Similarly, 10 of 12 patients, based on information available after two months have been deemed not to require any or only one anti-VE GF treatment. 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.

Based on the favorable safety profile and promising signals of effect at all dose levels Annexin has decided to stop patient recruitment. Future and larger randomised studies will hopefully confirm the effect on the disease course and reduced need of anti-VEGFs. If so, the company believe ANXV can become an important addition to the current standard of care to ease the burden on patients and society.

The company will present study update during upcoming ophthalmology meetings in Seattle in May.