Ophthalmology Month in Review: July 2024

This month's ophthalmology review delves into recent advancements in the ophthalmological pipeline and highlights three key studies that explore the expanding treatment landscape for retinal diseases and its integration into the broader medical field.

In July, the US Food and Drug Administration (FDA) granted approval to a pre-filled syringe of faricimab (Vabysmo) for a trio of retinal diseases, designed to simplify administration and enhance the treatment experience for patients and providers. The agency also accepted the supplemental Biologics License Application (sBLA) for Susvimo in the treatment of diabetic macular edema (DME) and diabetic retinopathy.

Genentech recently announced the reintroduction of Susvimo for neovascular (wet) age-related macular degeneration (nAMD), after a voluntary recall was announced in October 2022 after the implant failed to meet company safety standards.

Other recent studies examined the impact of prior authorizations on anti-vascular endothelial growth factor (VEGF) treatment in retina practices, the potential use of JAK inhibitor therapy for AMD among individuals with autoimmune diseases, and the effect of switching from one anti-VEGF agent to another without issue in treatment-resistant patients with nAMD.

Pipeline News

FDA Approves Prefilled Syringe of Faricimab (Vabysmo) for AMD, DME, and RVO

Announced on July 4, 2024, the FDA has approved a 6.0 mg single-dose prefilled syringe of faricimab (Vabysmo) for the treatment of neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).

The prefilled syringe is designed to simplify administration, and marks the first and only syringe with an FDA-approved bispecific antibody to treat retinal conditions.

“We are pleased that the US FDA has approved the Vabysmo pre-filled syringe for people living with wet AMD, DME, and RVO, which are some of the leading causes of vision loss,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development, Genentech.

Genentech Announces Reintroduction of Susvimo for Wet AMD

On July 8, 2024, Genentech announced the reintroduction of Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use via an ocular implant for nAMD. Formerly known as the Port Delivery System (PDS) with ranibizumab, Susvimo was initially FDA-approved in October 2021.

A year later, in October 2022, Genentech voluntarily recalled Susvimo after the ocular implant, insertion tool, and initial fill kit failed to perform to the company’s standards. Since the recall, Genentech indicated the Susvimo implant and refill needle were updated and testing has confirmed both are up to the designation performance standards.

“In my practice, I see many patients who are at risk of losing vision due to wet AMD and face a high burden of treatment,” said David Almedia, MD, MBA, PhD, founder, Erie Retina Research. “I’m excited to offer these patients Susvimo as an effective alternative to regular eye injections to help preserve their vision, without the need for frequent treatments.”

FDA Accepts sBLA for Susvimo in Treatment of DME, Diabetic Retinopathy

Announced on July 18, 2024, the FDA also accepted the supplemental Biologics License Application (BLA) for Susvimo for the treatment of DME and diabetic retinopathy. The filing was accepted based on the 1-year study results from the Phase 3 Pagoda and Pavilion studies, with each trial meeting its primary endpoint.

“If approved by the FDA, Susvimo can bring a new treatment paradigm for diabetic eye diseases,” Garraway said. “We hope to bring this option to people with DME and diabetic retinopathy as soon as possible to help maintain their vision and potentially their independence.”

Treatment Landscape

Anti-VEGF Prior Authorizations Often Delay Care in Retina Practices

Prior authorizations for anti-vascular endothelial growth factor (VEGF) drugs had an overall high approval rate but delayed patient care in retina practices, which can lead to irreversible vision loss.

More than 96% of 2000 requests for anti-VEGF therapies were ultimately approved but required a median of 100 minutes of clinic staff time, with 57.4% of patients experiencing a delay in care delivery.

“Though well-intentioned to mitigate rising costs, the use of current prior authorization procedures is associated with an administrative burden on retina practices and health care systems overall,” wrote investigators.

JAK Inhibitors May Reduce AMD Onset in Autoimmune Diseases

An administrative claims database analysis displayed evidence of an association between Janus kinase (JAK) inhibitor therapy and a lower risk of AMD development. Utilizing two databases, representing nearly 10 million US patients, JAK inhibitor therapy was linked to a significantly reduced risk of incident AMD during the first 6 to 18 months of treatment, in those aged >40 years with autoimmune diseases.

Switching to Faricimab Effective for Treatment-Resistant Wet AMD

Switching to faricimab from aflibercept could be a safe, effective option for patients with treatment-resistant nAMD, says a new retrospective case series study. The switch was correlated with significant anatomical improvement, trending toward visual stability, and the loading regimen appeared sufficient for non-treatment-naive patients with nAMD.

“A longer follow-up and larger studies are warranted to confirm these findings,” wrote investigators.

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