European Regulators Reject Eli Lilly's Alzheimer's Drug Kisunla Over Safety Concerns
• The European Medicines Agency's advisory committee has recommended against approving Eli Lilly's Alzheimer's treatment Kisunla, citing safety concerns related to brain swelling.
• European regulators determined that the risks of amyloid-related imaging abnormalities (ARIA) outweigh the potential benefits of the drug, creating a notable divergence from US regulatory decisions.
• This rejection marks another instance where European and American regulators have reached different conclusions on new Alzheimer's treatments, highlighting regional differences in benefit-risk assessment.
Five-Year Study Shows Aflibercept Treat-and-Extend Regimen Maintains Vision in Neovascular AMD Patients
• A multicenter Japanese study demonstrates that aflibercept using a treat-and-extend regimen maintained baseline visual acuity and significantly reduced central macular thickness in neovascular AMD patients over five years.
• Researchers identified smaller greatest linear dimension (GLD) as the only independent risk factor associated with better vision outcomes after five years of treatment (p=0.0024).
• The study revealed patients required fewer injections after the first year, though 33% of discontinued cases experienced recurrence, with higher recurrence rates in those who had received more total injections.
FDA Accepts NDA for Sydnexis' SYD-101: First Potential Pharmaceutical Treatment for Pediatric Myopia
• The FDA has accepted Sydnexis' New Drug Application for SYD-101, a low-dose atropine eye drop for pediatric myopia management, with a target action date of October 23, 2025.
• If approved, SYD-101 would become the first and only FDA-approved pharmaceutical option for treating progressive myopia in children in the United States, addressing a condition expected to affect 50% of the global population by 2025.
• The NDA is supported by the landmark STAR study, a 3-year Phase 3 clinical trial that enrolled 852 pediatric patients aged 3-14 years, making it the largest clinical study ever completed for pediatric myopia progression.
Ocular Hypertension: Over 60 Companies Advance Clinical Trial Pipeline
• The ocular hypertension market is expanding due to increased prevalence of conditions affecting aqueous humor outflow, leading to elevated intraocular pressure (IOP).
• Advancements like sustained-release implants and micro-dosing technologies are enhancing patient compliance and improving outcomes in ocular hypertension treatment.
• Enhanced imaging techniques, such as optical coherence tomography (OCT), facilitate early diagnosis and intervention, contributing to the growth of the ocular hypertension market.
• Over 60 companies are actively developing more than 70 pipeline drugs for ocular hypertension, signaling robust innovation and future growth potential in the domain.
Sozinibercept Shows Promise in Improving Visual Outcomes for nAMD Patients
• Sozinibercept, a novel VEGF-C/D inhibitor, is under investigation for neovascular age-related macular degeneration (nAMD) to improve visual acuity beyond current VEGF-A therapies.
• Phase 2b trials showed that sozinibercept combined with ranibizumab led to a statistically significant additional gain of 3.4 letters in BCVA compared to ranibizumab alone at 24 weeks.
• Ongoing Phase 3 trials (ShORe and COAST) are evaluating sozinibercept in combination with ranibizumab or aflibercept, with potential regulatory filings planned after 12-month efficacy analysis.
• Next-generation nAMD therapies like sozinibercept aim to target multiple pathways beyond VEGF-A to enhance vision and quality of life for patients, addressing the limitations of current treatments.
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