A novel intravitreal treatment for diabetic macular edema (DME) has demonstrated superior efficacy compared to standard therapy in a recent clinical trial, potentially offering patients a significant reduction in treatment frequency while improving outcomes.
The VERONA study, presented at the 2025 Retina World Congress in Fort Lauderdale, Florida, evaluated EYP-1901, an innovative therapy that combines varolanib packaged in a bio-erodible polymer administered via intravitreal injection for patients with center-involved DME and decreased vision.
Superior Efficacy and Durability
Dr. Carl D. Regillo, Director of the Retina Service at Wills Eye Hospital and partner at Mid Atlantic Retina, shared that the trial results were remarkably positive, with EYP-1901 outperforming aflibercept in both vision improvement and anatomical disease control.
"The VERONA study was a very successful study," Dr. Regillo stated. "In both doses tested compared to aflibercept, it performed very well, in fact, better than a single-dose of aflibercept in vision improvement and anatomy, that is, disease control."
Perhaps most significantly, the treatment demonstrated exceptional durability, with the majority of patients not requiring any supplemental anti-VEGF therapy for six months after a single administration of EYP-1901.
Addressing Current Treatment Limitations
The development of EYP-1901 addresses several critical challenges in current retinal treatments. Despite significant advances in ophthalmology therapeutics over recent decades, patients with conditions like DME face substantial treatment burdens, including frequent clinic visits for injections.
Current limitations in retinal treatments include:
- Suboptimal treatment responses for some conditions
- High patient treatment burdens with frequent injections
- Challenges in maintaining consistent patient engagement
- Logistical difficulties associated with regular medical visits
EYP-1901's extended duration of effect could significantly reduce these burdens while potentially improving outcomes through more consistent therapeutic levels.
Trial Design and Patient Population
The VERONA trial evaluated patients with center-involved diabetic macular edema with decreased vision, a condition that represents a significant cause of vision loss among working-age adults with diabetes. DME occurs when fluid accumulates in the macula due to leaking blood vessels resulting from diabetic retinopathy, causing vision distortion and potential vision loss if left untreated.
The study compared multiple doses of EYP-1901 against aflibercept, a current standard-of-care anti-VEGF therapy that typically requires frequent injections to maintain efficacy.
Mechanism of Action
EYP-1901 utilizes varolanib, delivered via a proprietary bio-erodible polymer that allows for sustained release of the active compound. This delivery system enables prolonged therapeutic effect from a single intravitreal injection, potentially transforming the treatment paradigm for retinal diseases.
The bio-erodible nature of the polymer means that, unlike some sustained-release platforms, it does not require removal after its therapeutic effect is complete.
Implications for Clinical Practice
Dr. Regillo emphasized the broader significance of this advancement, noting that collaborative efforts between clinicians and industry have driven substantial progress in ophthalmological therapeutics.
"What's exciting about clinical trial work is it gives us the opportunity to play a role or a part in what's going to make our field better and enhance the care of our patients for these common sight threatening diseases," Dr. Regillo explained.
The potential reduction in treatment frequency could have profound implications for patient care, potentially:
- Improving treatment adherence
- Reducing the economic and logistical burden on patients
- Decreasing the risk of injection-related complications
- Allowing retina specialists to manage more patients effectively
Future Directions
While the VERONA trial results are promising, further studies will likely explore the long-term efficacy and safety of EYP-1901, as well as its potential applications in other retinal conditions such as wet age-related macular degeneration and retinal vein occlusion.
Dr. Regillo's perspective on the trajectory of ophthalmology remains fundamentally optimistic. He views ongoing research as a critical pathway to enhancing patient care, particularly for sight-threatening diseases that require consistent, long-term management.
The development of longer-acting therapies like EYP-1901 represents a significant step forward in addressing the persistent challenges of retinal disease management, potentially improving both clinical outcomes and quality of life for patients with diabetic macular edema.
