Ophthalmology Month in Review: February 2025

Credit: HCPLive

February saw significant regulatory advancements and clinical trial milestones in ophthalmology, signaling progress in treating retinal diseases and corneal disorders. The US Food and Drug Administration (FDA) approved the first continuous delivery treatment for diabetic macular edema (DME), while an intravitreal insert met its Phase 2 endpoints, showing promise in reducing the treatment burden for DME patients.

Regulatory momentum continued with the FDA expanding the dosing label for a critical treatment for geographic atrophy and granting designation to regenerative therapy for dry AMD. Meanwhile, the approval pathway for biosimilars gained traction and the ophthalmology pipeline remains active, with topline results from a notable trial expected in the coming months. Additionally, the FDA's acceptance of a New Drug Application (NDA) highlights ongoing innovation in corneal cross-linking therapies for keratoconus, reinforcing the growing landscape of treatment options in ophthalmic care.

Here’s a recap of what happened in ophthalmology in February:

FDA Approves Susvimo for Diabetic Macular Edema

The FDA approved Genentech’s Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant, marking the first and only continuous delivery treatment for DME. Awarded based on positive 1-year results from the Phase 3 Pagoda study, this approval represented the second indication for Susvimo after its initial nod for neovascular (wet) age-related macular degeneration (nAMD) in 2021.

DURAVYU Hits Primary Phase 2 Endpoint, Reduces Treatment Burden in DME

DURAVYU (vorolanib intravitreal insert) achieved a meaningful improvement in vision and anatomy in eyes with diabetic macular edema (DME), meeting the Phase 2 VERONA trial’s primary and secondary endpoints. Both doses of DURAVYU (1.34 mg and 2.7 mg) showed extended time to the first supplemental anti-VEGF injection, compared with aflibercept control, at 6 months.

FDA Expands Dosing Label for Avacincaptad Pegol for Geographic Atrophy

The FDA expanded the label for Astellas Pharma’s avacincaptad pegol intravitreal solution (IZERVAY) for geographic atrophy (GA), extending the approved dosing beyond 12 months. The decision was announced after the company resubmitted its supplemental New Drug Application (nDA) in December 2024, based on feedback received from the FDA after an initial Complete Response Letter (CRL) the month prior.

FDA Grants RMAT Designation to RPESC-RPE-4W Transplantation for Dry AMD

The FDA awarded Regenerative Medicine Advanced Therapy (RMAT) designation to RPESC-RPE-4W transplantation for patients with dry age-related macular degeneration (AMD). At the time of the RMAT designation, Luxa Biotechnology announced the RPESC program had initiated a Phase 1/2a clinical trial for RPESC-RPE-4W transplantation in dry AMD.

Aflibercept Biosimilar AVT06 up for Review for Inherited Retinal Diseases

The FDA accepted the Biologics License Application (BLA) for AVT06, a proposed biosimilar for aflibercept (Eylea) to treat inherited retinal diseases (IRDs), including neovascular (wet) Age-related Macular Degeneration (AMD), macular edema, and diabetic retinopathy. Announced by Alvotech and Teva, the review is expected to be completed by the fourth quarter of 2025.

Sozinibercept Topline Results Expected in Q2 After COAST Trial Completion

Opthea concluded the final week 52 patient visit in the pivotal Phase 3 COAST trial investigating the superiority and safety of sozinibercept in combination with aflibercept for patients with nAMD. The COAST (Combination OPT-302 with Aflibercept Study) trial is expected to report topline results for sozinibercept for nAMD in early Q2 of this year.

FDA Accepts NDA for Epioxa for Keratoconus Treatment

The FDA has accepted the New Drug Application (FDA) for Glaukos Corporation’s Epioxa (Epi-on), a corneal cross-linking therapy for the treatment of keratoconus. The regulatory agency set a Prescription Drug User Fee Act (PDUFA) target action date of October 20, 2025, to review the Epioxa NDA, reflecting a standard 10-month review period.