At the 129th Annual Meeting of the American Academy of Ophthalmology (AAO) 2025 in Orlando, Florida, EyePoint Pharmaceuticals presented updates on its investigational therapy EYP-1901 (vorolanib) for diabetic macular oedema (DME) and wet age-related macular degeneration (wAMD). DME is a multifactorial disease driven by both vascular endothelial growth factor (VEGF) and inflammatory pathways. While anti-VEGF therapies remain the current standard of care, many DME patients experience suboptimal responses due to non-VEGF-related disease mechanisms. Given that both the DME and wAMD markets are crowded with VEGF inhibitors, there is a pressing need for therapies targeting alternative biological pathways. According to GlobalData, EYP-1901 has the potential to expand therapeutic options in this space.
EYP-1901 is a long-acting intravitreal implant designed to deliver sustained exposure to vorolanib. The compound functions as a tyrosine protein kinase inhibitor with activity against JAK1 and multiple VEGF receptors (VEGFR-1 and VEGFR-2). Because the tyrosine kinase pathway is implicated in both VEGF-dependent and independent mechanisms contributing to DME and wAMD, this approach could address disease aspects not targeted by existing therapies. The implant’s continuous drug release mechanism also offers the advantage of extending treatment durability and reducing injection frequency.
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Ashkan Abbey, MD, FASRS, FAAO, of Texas Retina Associates, presented findings from two key trials: the VERONA study for DME (NCT06099184) and the DAVIO-2 study for AMD (NCT05381948). In the VERONA trial, EYP-1901 significantly prolonged the time to supplemental injections while delivering meaningful improvements in visual acuity and retinal anatomy for patients with DME. Similarly, the DAVIO-2 trial demonstrated that in wAMD patients, treatment burden was reduced by 85%, and at six months, best-corrected visual acuity (BCVA) was non-inferior to aflibercept controls. Notably, in both studies, approximately two-thirds of EYP-1901–treated patients did not require additional injections, underscoring the therapy’s strong durability profile. Across nearly 200 patients, no concerning safety signals were observed, reinforcing a favourable safety and tolerability profile.
Enrolment has been completed for EYP-1901’s pivotal Phase III trials in wAMD—LUGANO (NCT06668064) and LUCIA (NCT06683742)—with data anticipated in the coming year. Pending positive outcomes, EyePoint Pharmaceuticals plans to submit the therapy for FDA review. Key opinion leaders (KOLs) interviewed by GlobalData expressed optimism about the drug’s potential, citing its novel mechanism of action and remarking that “there is a lot of expectation, and I really hope it works. If it works, it will be a game changer”.
According to GlobalData’s Pharma Intelligence Center, there are 13 Phase III candidates, 36 Phase II candidates, and 16 Phase I candidates for DME globally. As for wAMD, there are 30 Phase III candidates, 49 Phase II candidates, and 24 Phase I candidates globally.
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