At the AAO annual meeting in San Francisco, on Nov. 3-6, attendees had the opportunity to peruse the exhibition hall to see new and recently launched technologies and innovations available to the ophthalmic industry. In case you missed it, OM contributors offered their top highlights from the 2023 show floor.

DIAGNOSTIC TECHNOLOGY

Angelo Tanna, MD, says Heidelberg Engineering’s ANTERION platform, which was recently cleared by the FDA, is an exciting innovation. ANTERION combines biometry, IOL power calculation with corneal topography and tomography, anterior chamber metrics and high-resolution imaging. Additional proprietary features such as patented eye tracking and composite imaging technologies allow physicians to perform anterior segment examinations and acquire measurements via high-resolution swept-source OCT images. In addition, the platform features an Imaging App that focuses on the high-resolution visualization of the anterior segment and delivers OCT images. ANTERION also features apps designed to meet a variety of clinical needs. The Cataract App combines key measurements for cataract surgery planning, including integrated monofocal and toric IOL calculators; the Cornea App provides a comprehensive set of corneal measurements for the evaluation of a patient’s individual corneal geometry; and the Metrics App features swept-source OCT images with the anterior chamber displayed in a radial view.

Virtual Vision’s new portable virtual reality visual field headset allows for testing in any location with a Wi-Fi connection, eliminating the need for a dedicated room. Audio instructions in 17 languages guide the patient through the exam, which replaces the need for constant monitoring. The lightweight headset also allows patients to sit comfortably and have freedom of movement. “Virtual Vision’s VR visual field technology was impressive,” says Cynthia Matossian, MD, FACS. “Their clinical validation was conducted at Bascom Palmer Eye Institute, where they showed comparable accuracy to traditional standard automated perimetry. This device has the potential to significantly increase practice efficiency while providing a more pleasant experience for patients taking visual field tests.”

INTRAOCULAR LENSES

The LAL+, from RxSight, is a new member of the Light Adjustable Lens (LAL) family that will be available in the first quarter of 2024. The LAL+ incorporates a proprietary optical design that further extends the depth of focus prior to any light treatments while maintaining typical LAL level quality distance vision. This was achieved by adding a small continuous increase in central lens power relative to the LAL.

“I find this lens to be a great fit for certain patients and filled a gap in supporting refractive outcomes in cataract surgery,” says Scott LaBorwit, MD. “This lens will expand on this unique facet of an adjustable lens by creating more range at near without giving up distance.”

The LAL+ also stood out to O. Bennett Walton IV, MD, MBA. “In my experience, the LAL+ delivered the same easy adjustability and accuracy, while providing slightly more near. A little more near for our LAL patients is a wonderful thing.”

In an early report from a Phase 4 study, Steven Slade, MD, presented excellent clinical outcomes using the LAL+, with mean distance corrected intermediate and near vision that was better than that demonstrated for leading EDOF lenses, while retaining the distance, quality and adjustability of the LAL. “While the current LAL remains well positioned for post refractive and blended vision patients, the LAL+ can be an excellent choice for normal eyes and those patients who desire earlier visual performance,” he notes.

MEDICATIONS

Zack Oakey, MD, noted two recently FDA-approved therapies for the treatment of geographic atrophy (GA) secondary to AMD: SYFOVRE (pegcetacoplan injection) from Apellis Pharmaceuticals and IZERVAY (avacincaptad pegol intravitreal solution) from Iveric Bio, an Astellas company.

“GA is a major source of vision loss for non-exudative AMD,” says Dr. Oakey. “Until recently, no FDA-approved agent has been able to reduce progression. While one dietary study released by the National Eye Institute demonstrated reduction in progression of non-foveal GA with the use of an alternative Mediterranean diet, its data were limited to patient self-report. Now two agents have been FDA-approved, SYFOVRE and IZERVAY. Their data are limited to 24 months in OAKS/DERBY in the former case and 12 months in the GATHER2 latter — both demonstrate reduction in progression but with some limitations in their data and ability to reduce foveal progression. Acuity is unchanged when these medications are used.”

Another drug, darovasertib, a protein kinase C inhibitor, from IDEAYA Biosciences, is showing some promising results for uveal melanoma. “Recently, darovasertib has been studied as a medication used to treat metastatic uveal melanoma. However, during clinical trials it was noted that some patients' primary cancer in the eye had yet to be treated. They were still enrolled and treated with darovasertib while the eye component of the cancer was planned to be treated. To the surprise of investigators, the eye tumor shrunk, and the radiation dose had to be recalibrated. But, more importantly, it was proposed that the medication could be effective as a treatment option. It is exciting to see how the medication might shape the landscape of uveal melanoma either as neo-adjuvant, adjuvant or possibly as primary treatment” he says.

Orasis Pharmaceuticals’ QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% recently became the latest FDA-approved treatment for presbyopia in adults. QLOSI, a prescription eyedrop that can be used daily, or as needed, up to twice per day, is a preservative-free formulation of pilocarpine, an established eye-care therapeutic. It was designed to achieve an optimal balance between efficacy, safety and comfort. QLOSI demonstrated efficacy 20 minutes after administration and can last up to 8 hours, as measured on day 15, to improve near vision without impacting distance or night vision. QLOSI is expected to be commercially available in the United States in the first half of 2024.

Regeneron Pharmaceuticals’ EYLEA HD (aflibercept) Injection 8 mg recently received FDA approval. This new formulation of aflibercept has four times the dose of standard aflibercept 2 mg. In the PULSAR and PHOTON trials, aflibercept 8 mg showed longer duration of treatment effect as compared to aflibercept 2 mg. “It is a new treatment option for patients to help alleviate treatment burden from frequent anti-VEGF injections for wet AMD and diabetic macular edema,” says Priya Vakharia, MD.

Tarsus Pharmaceuticals’ XDEMVY (lotilaner ophthalmic solution) 0.25% is the first FDA-approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis. The FDA approval of XDEMVY, formerly known as TP-03, is based on results from two randomized, multicenter, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2), designed to evaluate the safety and efficacy of XDEMVY in 833 patients, 415 of which received XDEMVY. Efficacy was demonstrated by a significant improvement in eyelids (reduction of collarettes, the pathognomonic sign of the disease, to no more than two collarettes per upper lid) in each study by Day 43, with some patients seeing improvement as early as 2 weeks.

SURGICAL DEVICES AND TECHNOLOGY

Ace Vision Group’s Gen II VisioLite Ophthalmic Laser System is a first-in-class 2.94-um Er:Yag laser that contains a patented robotic motion controller, eye tracker and real-time Anterior Swept Source OCT, which allows the device to reach 360° of the extreme areas around the eye. The initial use for this device is Laser Scleral Microporation (LSM), a clinical-stage, minimally invasive rejuvenation therapy for treating presbyopia and potentially other eye diseases. The in-line OCT can perform real-time adaptive depth control. The VisioLite is designed with a software module to make the Microporation patterns precise, customizable and repeatable. The ideal candidate for the LSM procedure is the emmetropic presbyope, and individuals with laser vision correction to emmetropia are also candidates. Since LSM does not touch the visual axis, it can be combined with other procedures. It is performed in the office and takes less than 10 minutes.

“The Gen II VisioLite will be a novel, non-lens-based procedure for presbyopia that can be repeated. It would offer another option for a bridge between laser vision correction/implantable collamer lens and cataract surgery,” says Luke Rebenitsch, MD.

The Gen II VisioLite is undergoing final verification and validation in preparation for the FDA 510k submission and the first human studies in the United Kingdom.

Alcon’s new open-platform NGENUITY 1.5 Digital 3D Visualization System provides sharp visualization with usability, color, contrast and magnification enhancements. It also offers connectivity to ARGOS Biometer diagnostic images to precisely overlay incisions, capsulorhexis, IOL centration, toric alignment and more.

“Ngenuity 1.5 is the current gold standard to which all other digital platforms will be competing against,” says Dr. Rosenberg. “With a fully integrated operative suite, all preoperative measurements including IOL calcs are visible prior to starting the case. The operative controls of an Alcon Centurion or Constellation are all heads-up as well. Digital enhancement filters yield a better operative experience and improved visualization. Let us not forget about iris registration, where the patient's eye is registered to the preoperative eye, confirming correct laterality and IOL, hopefully replacing ‘faulty’ time-outs in the future.”

The new Eyetelligence surgical planning tool from Bausch + Lomb is designed to help surgeons work smarter and more efficiently using cloud-based technology. The software delivers a secure flow of information from the office to the operating room, ensuring surgeons can manage data and personalize their approach to each case digitally without the need for multiple documents, sources and folders. Surgeons will be able to work with various EMR and diagnostic platforms, eliminating the need to purchase specific equipment or train staff on new technologies. The Eyetelligence surgical planning software will offer both a surgeon-focused and a nursing-focused app to simplify the complex and time-consuming surgical planning process and help improve workflow.

Dr. Matossian says that she likes the tool’s capability of allowing “surgeons to plan their procedures from the office to the operating room with secure connectivity.”

Another highlight platform was the SeeLuma Fully Digital Surgical Visualization Platform from Bausch + Lomb and Heidelberg Engineering. SeeLuma provides ophthalmic surgeons with a new level of visualization compared to optical, hybrid and retrofitted microscopes. Developed to facilitate even the most complex surgical procedures, SeeLuma features a heads-up 3D monitor that facilitates 3D heads-up surgery using next-generation 3D 55” and 31” 4K monitors, multiple digital display options and an intuitive interface for sharp visualization, ergonomics, smooth workflow and an immersive educational experience. SeeLuma will be introduced in the United States this month.

“There is a significant buzz around SeeLuma,” says Dr. Rosenberg. “Education has always been an important aspect of medicine whether as a resident or a tenured professor. New techniques and approaches are developed every month, and this principle underpins the crux of SeeLuma. With a 4K 3D integrative system, Bausch + Lomb is offering real time support with touchscreen mechanics and an ‘Assist Mode,’ which allows for real-time annotation and collaboration during surgery.”

Dr. Rosenberg was also impressed by the new Beyeonics One (BVI) exoscope, which is a high-definition fully digital imaging platform that enables surgeons to see a magnified, 3D image of the surgical field. It delivers enhanced visualization and on-demand consolidated preoperative information, which are accessible and controlled by an immersive augmented reality surgical headset. “The Beyeonics One exoscope is a groundbreaking innovation clearly a generation ahead,” says Dr. Rosenberg. “Integrating augmented reality into modern day cataract surgery is not merely going to be the way surgery is done, but rather the foundation for all future applications and approaches as well. I was fortunate to trial the new headset, which was more like an Oakley visor, lightweight, extremely mobile and absolutely wild.”

The ZEPTOLink IOL Positioning System, from Centricity Vision, integrates the ZEPTO precision pulse capsulotomy technology with any phaco system to streamline cataract surgery. ZEPTOLink uses suction and irrigation provided by the phaco system, enabling surgeons to fully control the ZEPTO handpiece apposition, suction, energy delivery and release using the phaco foot pedal. Some features include a small ergonomic console that attaches to any phaco system; modern touchscreen display with voice-supported functions; a dedicated ZEPTOLink handpiece for efficient set-up, priming and operation by a single person all within the sterile field; and ZEPTO technology for precise, consistent and centered capsulotomies with 360° IOL overlap.

Johnson & Johnson Vision’s ELITA Femtosecond Laser for the creation of LASIK flaps features low energy per pulse, fast laser repetition rate and small spot size (1µm), smooth stromal bed and sub-micron precision. Additionally, ELITA features an intuitive user interface, modular design and a quick system startup in less than 5 minutes. Also, it is designed to reduce complications, improve visual outcomes and enable fast visual recovery.

The ZEISS ARTEVO 800 ophthalmic microscope with integrated intraoperative OCT (RESCAN 700) helps reveal insights such as epiretinal membrane, macular edema, posterior hyaloidal traction and retinal detachment, allowing for strategy adjustments during surgery. It features a non-contact fundus viewing system, RESIGHT 700, enabling surgeons to see a clear and detailed view of the retina.

“ARTEVO includes a full host of integrative solutions and houses the most advanced anterior and posterior segment OCT on the market: RESCAN,” says Dr. Rosenberg. “Leveraging live intraoperative OCT imaging has paved the way for subretinal injection therapies, and partial thickness corneal transplants. Interestingly, a unique partnership has evolved with Apple, and Zeiss is developing an AI-backed IOL calculator to pair with their digital suite, one that I am excited to trial.”

According to Dr. Rosenberg, “The future of ophthalmic surgery is here. Unless we wish to continue operating with loupes, the time has come to explore the available systems and understand not just what they provide now, but envision what doors they will open up for us in the years to come.” OM

Disclosures: Dr. Matossian is a speaker and consultant to Bausch + Lomb. Dr. Rosenberg serves as a consultant to Alcon and BVI. Dr. Vakharia is a consultant and speaker for Regeneron. Dr. Walton is a consultant for RxSight. Dr. LaBorwit, Dr. Oakey, Dr. Rebenitsch and Dr. Tanna reported no financial relationships or conflicts.