Annexin Pharmaceuticals AB announced that an independent evaluation of potential signals of effect has been carried out in the company's Phase 2-study in retinal vein occlusion with the investigational new drug ANXV. Positive findings justify an extended follow-up period. A group of leading independent US ophthalmologists has conducted an evaluation of the available information from patients treated so far in the placebo-controlled study.

The evaluation confirmed an unexpectedly long duration of effect with a single dose of standard of care anti-VEGF treatment in two of five treated patients. These two patients also had some positive effects on visual acuity and the retina already during the four weeks before standard of care treatment was used. The expert group recommended unmasking the treatment to clarify whether the treated patients received placebo or ANXV.

The unmasking showed that the two patients with potential signals of effect had received ANXV. No clear signals of effect were observed in the other patients in the study where two had received ANXV and one had received placebo. The experts also recommended that the study should continue with a longer follow-up time and without a placebo group, since ANXV treatment has not raised safety concerns.