What to know about the most recent treatment and management developments in AMD

Age-Related Macular Degeneration (AMD) Awareness Month arrives amid a period of notable clinical and regulatory activity that reflects both progress and ongoing challenges in the field. In recent months, developments have ranged from regulatory setbacks—such as the FDA issuing a complete response letter to Outlook Therapeutics for ONS-5010/LYTENAVA—to emerging real-world data from the global SPECTRUM study evaluating aflibercept 8 mg in neovascular AMD. At the same time, research advances continue to explore new treatment frontiers, including early findings on the PRIMA retinal implant for patients with advanced geographic atrophy. Together, these updates highlight the evolving therapeutic landscape and underscore the continued focus on innovation, evidence generation, and patient care in AMD management. Here is a research round-up of the most notable, recent developments in AMD treatment and management:

FDA sends CRL to Outlook Therapeutics for ONS-5010 resubmission

Outlook Therapeutics, Inc reported that the FDA has issued a complete response letter (CRL) concerning the resubmitted biologics license application (BLA) for ONS-5010/LYTENAVA (bevacizumab-vikg).^1,2 The letter noted that the agency cannot approve the application in its current form for the treatment of wet age-related macular degeneration (wet AMD).¹

The FDA stated in the CRL that the additional mechanistic and natural history data included in the BLA resubmission did not change its prior review conclusion, according to Outlook Therapeutics.¹ Although the single adequate and well-controlled study demonstrated efficacy, the FDA again recommended that confirmatory evidence of efficacy be submitted to support the application, without indicating what type of confirmatory evidence would be acceptable.¹

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Early SPECTRUM results outline week 8 real-world outcomes with aflibercept 8 mg

A prespecified Week 8 analysis from the global SPECTRUM study provides early real-world data on intravitreal aflibercept 8 mg in patients with neovascular age-related macular degeneration (nAMD). The prospective observational study is being conducted across 18 countries and includes treatment-naïve (TN) and previously treated (PT) patients aged 50 years or older who were prescribed aflibercept 8 mg by their physicians as part of routine clinical practice.¹

The first author of the study is Clare Bailey from the Department of Ophthalmology at University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.¹

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PRIMA retinal implant found to restore vision in patients with advanced GA

An editorial published in the New England Journal of Medicine¹ referred to the Photovoltaic Retina Implant Microarray (PRIMA) Implant (Science Corporation) as “the first treatment to restore vision” in patients with advanced geographic atrophy (GA) associated with age-related macular degeneration (AMD).

The editorial highlights the study by Holz and colleagues² printed in the same issue of the journal. The authors reported the 12-month results achieved in patients with severe visual loss from GA secondary to AMD.

The editorial was authored by Jacque L. Duncan, MD, professor of ophthalmology and chair of the Department of Ophthalmology, University of California, San Francisco, who did not participate in the PRIMA study.

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