Exonate to Begin Phase 2b Trial of Eye Drop for Early Diabetic Retinopathy
Exonate has announced plans to advance its lead candidate, EXN407, into a Phase 2b clinical trial for non-proliferative diabetic retinopathy (NPDR), marking a potential breakthrough in the treatment of this vision-threatening condition.
The upcoming study, named CLEAR-DE, is set to begin in early 2026 and will evaluate efficacy, dosing, and safety in 140 NPDR patients across trial sites in Australia, the Middle East, and China.
From Promising Early Data to Larger-Scale Testing
The decision to progress follows positive results from Exonate’s Phase 1b/2a trial, announced in March 2024.
In that earlier study, EXN407 met its safety and tolerability endpoints, with no drug-related serious adverse events and high patient compliance. Importantly, exploratory efficacy signals revealed a reduction in vascular leakage – a key driver of diabetic retinopathy progression – providing early evidence of clinical benefit.
A Major Challenge in Diabetic Eye Disease
Diabetic retinopathy affects around one-third of the global diabetic population, with NPDR representing its early stage. If left untreated, NPDR can progress to more severe disease stages, leading to permanent vision loss.
Current standard treatments typically involve monthly intraocular injections, which are often delayed until symptoms worsen. This late-stage intervention approach can allow irreversible damage to occur before treatment begins.
How EXN407 Works
EXN407 is a first-in-class, twice-daily eye drop formulation designed to inhibit SRPK1. By modulating VEGF expression via alternative mRNA splicing, it selectively targets pro-angiogenic isoforms responsible for abnormal retinal blood vessel growth.
This innovative mechanism of action aims to deliver therapeutic benefits much earlier in the disease process, potentially delaying or even preventing the onset of advanced diabetic retinopathy.
Potential to Transform the Treatment Landscape
Exonate’s Chief Executive Officer emphasised that the Phase 1b/2a results demonstrate the clear potential of EXN407 as a non-invasive treatment for early-stage diabetic eye disease.
They noted that this therapy could transform the treatment paradigm, offering clinical benefits without the burden and risks associated with frequent eye injections – a shift that could be significant for both patients and physicians.
The company is now actively seeking strategic partners to support the execution of the CLEAR-DE trial.
Looking Ahead
With the CLEAR-DE Phase 2b trial set to commence in 2026, Exonate is positioning itself at the forefront of innovation in diabetic eye care.
If EXN407 continues to deliver on its early promise, it could represent a major milestone – bringing a safe, effective, and patient-friendly treatment option to those at risk of vision loss from NPDR, and reshaping how this common complication of diabetes is managed worldwide.
News Credits: Exonate to launch phase 2b trial of EXN407 for diabetic eye disease
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