UK MHRA approves phase 2a study for ANXV for diabetic retinopathy

(Image credit: AdobeStock/Janis Smits)

UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the start of a clinical Proof of Concept phase 2a study with the drug candidate ANXV in the eye disease diabetic retinopathy (DR). Patients with newly diagnosed retinal vein occlusion (RVO) will also be included, following the completed Phase 2a study in RVO and in preparation for the coming Phase 2b study.

The aim of this research is to evaluate a shorter treatment cycle than previously used. It is expected that first patients will be treated in the coming month with initial data to be released approximately 3 months later.¹

In the press release¹ issued by Annexin Pharmaceuticals, the company developing ANXV, the CEO, Anders Haegerstrand, is quoted as saying, "Diabetic retinopathy is basically a vascular disease caused by damage to small blood vessels in the retina. Our previous promising Phase 2a data in RVO strengthen our expectation that ANXV may also be effective in diabetic retinopathy – a serious condition where there is a high demand for new treatment options. The study as a whole is of great importance as, in addition to broadening the potential area of use and thereby increasing the future market for ANXV, we can get answers to questions that arise in our ongoing partnership discussions."

Paulo-Eduardo Stanga will serve as the principal investigator for the Phase 2a study, which will be conducted at The Retina Clinic in London, United Kingdom. The study is designed so that first patients in each disease indication will be treated for 5 days with ANXV and then followed up with detailed tests for 30 days. All patients are followed for an additional 90 days. Evaluations as to t safety, tolerability and any signals of effect that may be related to ANXV will be made. In addition to standardized tests of best corrected visual acuity (BCVA), the degree of diabetes-caused retinal damage, swelling of the retina and the need for anti-VEGF injections, objective functional tests and analyses of blood flow and vascular changes are performed.¹

The 1-month results will impact the decisions for the treatment of the next patients within the 2 indications. It is an open-label study without a placebo group or comparison with another drug. The cohort is planned to include 3 patients with diabetic retinopathy, as well as 3 patients with newly diagnosed RVO.¹

The adaptive study design, with evaluation of 2 indications in parallel at a single clinic, will allow for a time- and cost-effective study. The study will also provide the company with important information for the preparation of a phase 2b study, which is expected to be conducted by or in collaboration with an industrial partner.¹

Reference:

1. Annexin receives approval for Phase 2a study in diabetic retinopathy and RVO. Annexin Pharmaceuticals. News Release. August 7, 2025. Accessed August 15, 2025. https://annexinpharma.com/mfn_news/annexin-receives-approval-for-phase-2a-study-in-diabetic-retinopathy-and-rvo/