FDA Approves Zeiss MEL 90 Excimer Laser and Accepts Revised sNDA for Izervay
FDA Approves Zeiss MEL 90 Excimer Laser
The FDA has granted approval to the excimer laser MEL 90 from Zeiss Meditech, marking a significant advancement in the treatment of myopia, hyperopia, and mixed astigmatism. This laser integrates seamlessly into the Corneal Refractive Workflow from Zeiss, complementing the Visumax 800 and SMILE pro software to enhance surgical correction outcomes. The MEL 90 is now available in the US, offering a streamlined approach to refractive surgery.
Revised Supplemental New Drug Application for Izervay Accepted
In another pivotal development, the FDA has accepted the revised supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol intravitreal solution), aimed at treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This acceptance follows a Complete Response Letter from the FDA in November 2024 and a subsequent meeting between the FDA and Astellas. The application has been designated as a Class 1 resubmission, with a target action date set for February 26, 2025.
Insights into Eye Care Providers' Frame Buying Habits
A new research report from The Vision Council, titled 'Focused inSights 2024: Frame Buyers,' provides an in-depth analysis of how eye care providers select and source eyeglasses frames. The report covers various aspects, including the frequency of purchases, sourcing locations, and preferences for frame styles and materials, offering valuable insights into the industry's supply chain dynamics.
Dietary Inflammatory Index Linked to Non-Refractive Visual Impairment
A study conducted by Chinese researchers has identified a positive association between the Dietary Inflammatory Index (DII) and non-refractive visual impairment in the US population. This type of visual impairment results from ocular diseases rather than the eye's shape, highlighting the importance of dietary considerations in eye health.
AOA Releases Clinical Practice Guideline for POAG
The American Optometric Association (AOA) has published the first edition of 'Care of the Patient with Primary Open-Angle Glaucoma,' an evidence-based clinical practice guideline. This guideline aims to enhance the quality of healthcare by providing optometrists with a scientific foundation for diagnosing and treating patients with primary open-angle glaucoma, ensuring that care is based on the latest research.