EyePoint Pharmaceuticals has announced positive six-month results from its Phase 2 VERONA clinical trial evaluating DURAVYU™ (vorolanib intravitreal insert) for diabetic macular edema (DME) treatment. The trial demonstrated significant efficacy and safety milestones, positioning DURAVYU as a potential breakthrough in DME management.
Clinical Efficacy and Treatment Burden Reduction
The DURAVYU 2.7mg dose showed remarkable efficacy, achieving a +7.1 letter improvement in best-corrected visual acuity (BCVA) and a 76-micron reduction in central subfield thickness (CST) at week 24. Notably, 73% of patients treated with DURAVYU 2.7mg remained supplement-free compared to 50% in the aflibercept control group, representing a two-thirds reduction in treatment burden.
"We are extremely pleased to report these highly positive VERONA results that demonstrate 2.7mg DURAVYU immediately and meaningfully improves both visual acuity and anatomy in DME patients with a superior dosing interval and excellent safety," said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint.
Safety Profile and Clinical Implications
The trial revealed a favorable safety profile with no DURAVYU-related ocular or systemic serious adverse events. There were no reported cases of endophthalmitis, retinal vasculitis, insert migration, or intraocular inflammation, addressing key safety concerns in ocular drug delivery.
Dr. Carl Regillo, Chief of Retina Service at Wills Eye Hospital, emphasized the significance of these results: "The diabetes epidemic and associated increase in DME patients has resulted in a significant burden to patients and the healthcare system. The number of diabetic retinopathy patients is predicted to reach 16 million by 2050."
Study Design and Future Development
The VERONA trial enrolled 27 patients, randomizing them to receive either 1.34mg or 2.7mg DURAVYU doses or aflibercept control. Both DURAVYU doses met the primary endpoint of extended time to first supplemental injection versus aflibercept control.
Dr. Ramiro Ribeiro, Chief Medical Officer, noted, "The magnitude of these results gives us confidence moving forward into a Phase 3 noninferiority program with a differentiated treatment for patients with DME who need effective, safe and durable treatment options."
Market Impact and Development Timeline
DME represents the second-largest market in retinal diseases after wet age-related macular degeneration. EyePoint plans to initiate Phase 3 pivotal trials by the end of 2025, following discussions with the FDA in the second quarter. The company's ongoing pivotal trials in wet AMD are scheduled for readout in 2026.
The technology behind DURAVYU combines vorolanib, a selective tyrosine kinase inhibitor, with EyePoint's proprietary Durasert E™ bioerodible delivery system. This approach offers immediate bioavailability and zero-order kinetics drug delivery, potentially addressing the significant unmet need for more durable DME treatments.
