• Genentech, a member of the Roche Group, announced the FDA approved Vabysmo (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). RVO is the third indication for Vabysmo, in addition to wet, or neovascular, AMD and diabetic macular edema. The approval is based on positive results from the global Phase 3 BALATON and COMINO studies that demonstrated monthly treatment with Vabysmo provided early and sustained improvement in vision in people with branch and central RVO, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept. This was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluid.

• Bausch + Lomb announced the US launch of SeeNa, an ophthalmic diagnostic system for refractive cataract patients that is fully integrated with Bausch + Lomb’s Eyetelligence surgical planning software to help streamline surgical planning and information flow. SeeNa captures nine key measurements necessary for evaluating patients’ eyes and determining the cataract IOL power calculation in one single step. It also offers a user-friendly interface, allowing clinicians and staff to quickly master acquisition and operation and receive results in seconds, the company says. The integrated Eyetelligence software connectivity allows for efficient upload of the measurements, enabling a seamless, secure flow of this data from the office to the operating room.

• The FDA issued a warning for consumers not to purchase and to immediately stop using 27 over-the-counter eyedrop products due to the potential risk of eye infections that could result in partial vision loss or blindness. Patients who have signs or symptoms of an eye infection after using these products should talk to their health-care provider or seek medical care immediately. The products are marketed under the following brands: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up, Velocity Pharma and Walmart Equate. These products are intended to be sterile. The FDA recommended the manufacturer of these products recall all lots on Oct. 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. CVS, Rite Aid, Target and Walmart are removing the products from their store shelves and websites. Products branded as Leader, Rugby and Velocity may still be available to purchase in stores and online and should not be purchased. The FDA has not received any adverse event reports of eye infection associated with these products. The FDA encourages health-care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program: Complete and submit the report online at Medwatch; or download and complete the form, then submit it via fax at 1-800-FDA-0178.

• LENSAR Inc. announced a step forward in its plans to integrate phacoemulsification technology from Oertli Instrumente AG into the ALLY Adaptive Cataract Treatment System. Oertli filed a 510(k) with the FDA for its Faros easyPhaco device, which would bring LENSAR closer to delivering combined femto phaco technology. According to LENSAR, the combined femtosecond laser and phacoemulsification system will be the first system to combine these technologies. With the combined system, surgeons will also save space in the operating room and optimize cataract surgery all on one system, the company says.

• ZEISS Medical Technology announced digital enhancements to the cataract, corneal refractive and retina workflows as part of the ZEISS Medical Ecosystem. The ZEISS VISULAS yag therapeutic laser received 510k clearance by the FDA, expanding offerings within the ZEISS Cataract Workflow. It provides a precise and compact laser workstation for safe and effective posterior capsulotomy and iridotomy procedures. The therapeutic laser can be connected with ZEISS FORUM and integrates into the ZEISS Cataract Workflow. Additionally, the ZEISS AI IOL Calculator on ZEISS VERACITY Surgery Planner can now calculate the ZEISS CT LUCIA 621P IOL. In addition, ZEISS is launching a digital marketing cloud-based software solution, ZEISS PROSPARA, that provides a wide range of features to assist in enhancing online visibility, managing reputation and social media engagement. ZEISS will also showcase a digitally-connected retina workflow, including advanced diagnostic and surgical devices that help manage and treat retina diseases such as AMD, geographic atrophy and diabetic retinopathy. To learn more, click here.

• EyeMD EMR announced the launch of Axon, a third-generation patient engagement system that extends the functionality of its suite of products. This solution allows clinicians to digitally interact with their patients outside of the clinical setting to improve efficiencies and enhance quality of care. Axon builds on the functionality of previous generation systems by leveraging clinical insights to drive patient communication automation. Patient-captured images and clinical data are used to create workflow efficiencies for the practice.

• Nextech will showcase some of the recent developments to its software at AAO 2023. On the administrative end, it will feature solutions in online scheduling, revenue cycle enhancements that minimize misunderstanding of what patients owe, and streamlined and automated electronic remittance advice workflows. On the clinical end, the company improvements include a knowledge base with fast response times and simple customization of clinical information, streamlined, time-saving document and image review queues, oculoplastic charting developments, and solutions that automatically track open referral loops.

• ViaLase Inc. completed enrollment of VIA-002, the company's pivotal trial of the ViaLase Laser to treat adult patients with primary open angle glaucoma. The ViaLase Laser combines the precision of femtosecond laser technology and the accuracy of micron-level image guidance to deliver femtosecond laser image-guided high-precision trabeculotomy, or FLigHT, a noninvasive glaucoma treatment. In the study, 152 subjects were randomized to either the ViaLase Laser or selective laser trabeculoplasty. The primary effectiveness endpoint is a reduction in mean unmedicated IOP from baseline to 6 months and 12 months. Secondary effectiveness endpoints are the percentage of eyes with a >20% reduction in unmedicated IOP at 6 months and 12 months with no secondary surgical intervention to treat glaucoma and a reduction in mean number of hypotensive medications from screening to 6 months and 12 months. 

• Prevent Blindness declared November Diabetes-related Eye Disease Awareness Month, and is providing the public with a variety of tools to prevent unnecessary vision loss from diabetes. New this year are resources on Diabetes and Youth that includes a downloadable fact sheet, shareable social media graphics and a dedicated webpage. Other resources available include two episodes in Prevent Blindness’ Focus on Eye Health Expert Series dedicated to diabetes and vision, a Diabetes + The Eyes Educational Toolkit (available in English and Spanish), a Focus on Diabetes video series, a Diabetes, Vision Loss, and Mental Wellness video, a Diabetes-related Eye Disease and Mental Health fact sheet (available in English and Spanish), and a Vision Integration Library. In addition, Prevent Blindness recently collaborated with award-winning actress, dancer and director Debbie Allen and Regeneron for the Gr8 Eye Movement, a new disease awareness campaign that aims to address gaps in how people understand the risk of developing certain serious retinal diseases, including diabetes-related macular edema and diabetes-related retinopathy. For additional information on these resources, click here. 

• In a letter to Samsung Bioepis, the FDA granted the company an interchangeability designation stating Byooviz (ranibizumab-nuna) to be interchangeable with Lucentis (ranibizumab injection). The approval is based on a supplemental biologics license application that was submitted by Samsung Bioepis. The FDA Approval letter stated, "Byooviz (ranibizumab-nuna) injection 0.5 mg (10 mg/mL) for intravitreal injection in a single dose vial to be interchangeable with the corresponding presentation of Lucentis (ranibizumab injection) 0.5 mg (10 mg/mL) for intravitreal injection, for the following indications: Neovascular (wet) AMD; macular edema following retinal vein occlusion; and myopic choroidal neovascularization.”


• Oregon Health & Science University ophthalmologist, scientist and inventor David Huang, MD, PhD, received the United States’ highest honor for technological achievement. President Joe Biden presented Dr. Huang and others with the National Medal of Technology and Innovation for developing the imaging technology known as optical coherence tomography (OCT), which routinely helps prevent blindness. James G. Fujimoto, PhD, and Eric A. Swanson, MS, of the Massachusetts Institute of Technology and co-inventors of OCT with Dr. Huang, were also honored at the White House ceremony. The medal recognizes “American innovators whose vision, intellect, creativity, and determination have strengthened America’s economy and improved our quality of life,” the White House said in an announcement.  

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.