In The News
Alcon’s Voyager direct selective laser trabeculoplasty (DSLT) device is now commercially available in the United States. The Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser is a contactless laser for glaucoma. Voyager DSLT is controlled through a touchscreen, taking the slit lamp and manual gonio lens aiming out of the equation, and reduces the specialized training required with manual select laser trabeculoplasty. Alcon also announced the US launch of SYSTANE PRO Preservative-Free (PF), an over-the-counter eye drop for dry eye.
Zeiss Medical Technology’s MEL 90 excimer laser won US Food and Drug Administration (FDA) approval. The decision gives the laser technology simultaneous approval for all 3 major indications, including myopia, hyperopia and mixed astigmatism.When performing LASIK for myopia at 500 Hz, the laser can intra-operatively ablate 1 diopter in1.3 seconds. The system’s graphic user interface supports fast treatment procedures, and the touchscreen can be flexibly positioned wherever it is needed.
Heidelberg Engineering announced FDA clearance of the Epithelial Thickness Module, available through the Anterion Cornea App. The module offers advanced thickness mapping and data insights to evaluate both the epithelial and stromal structures. Featuring detailed parameters and color maps, the module is designed to support refractive surgery planning, assess ocular surface evaluation, aid in corneal ectasia assessment and assist in a variety of other cornea diagnostics.
Glaukos Corp. received the “Day 74” notification from the FDA acknowledging the previously submitted new drug application (NDA) for Epioxa (Epi-on), its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act goal date for the completion of the FDA’s review of the Epioxa NDA is set for Oct. 20, 2025.
Genentech, a member of the Roche Group, announced the FDA approved Susvimo (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME). According to Genentech, Susvimo is the first and only FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections. Susvimo is now available to US retina specialists and their patients with DME.
The FDA approved an expanded label for Izervay (avacincaptad pegol intravitreal solution; Astellas Pharma), removing limitations on treatment duration for geographic atrophy secondary to age-related macular degeneration. The decision provides physicians and patients with greater flexibility in managing the disease. The approval follows Astellas’s resubmission of a supplemental NDA in December 2024, shortly after addressing concerns raised in the FDA’s Complete Response Letter.
New World Medical received 510(k) clearance from the FDA for its VIA360 Surgical System for the delivery of controlled amounts of viscoelastic fluid during ophthalmic surgeries. The VIA360, which is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures, supports a variety of surgical workflows, whether combined with cataract surgery or in standalone procedures.
AI Optics received FDA 510(k) clearance for its Sentinel Camera handheld retinal imaging system that captures high-quality images of the human eye. The system enables point-of-care retinal imaging, and is designed to support non-dilated imaging. The design was developed to meet the needs of general health care providers, including primary care, optometry, retail health clinics and home health settings.
Norlase announced the commercial launch/FDA 510(k) clearance of LYNX, a laser indirect ophthalmoscope with integrated pattern-scanning capabilities. LYNX is battery-powered and provides surgeons with an “untethered” laser solution. The laser and pattern module is built into the ergonomic headset, eliminating the need for an external laser source, and a wireless user interface offers surgeons more options to streamline their treatment flow.
EssilorLuxottica received FDA clearance in the United States for its Nuance Audio Glasses. The device, which integrates hearing aid functionality into a pair of smart glasses, is designed to offer both vision and hearing support. The glasses target individuals with mild to moderate hearing loss.
The FDA approved Encelto (revakinagene taroretcel-lwey; Neurotech Pharmaceuticals), an ocular insert that represents the first treatment for Macular Telangiectasia type 2 (MacTel). Encelto (formerly known as NT-501) is an encapsulated cell therapy that is implanted in the vitreous; it is designed to deliver sustained therapeutic doses of ciliary neurotrophic factor (CNTF) to the retina. This technology is designed to slow the progression of MacTel.
iCare, a subsidiary of Revenio Group, will commercially launch the latest version of its iCare MAIA microperimeter in the first quarter of 2025. iCare MAIA features a renewed hardware platform with fully automated operations and a 15’’ multi-touch display, along with an intuitive user interface. The auto-alignment feature keeps the device aligned with the eye under exam, compensating for head movements throughout the test.
Optos PLC introduced MonacoPro, an upgraded ultrawidefield imaging system that integrates spectral domain optical coherence tomography (OCT). The new device is designed to improve diagnostic precision and offers enhanced OCT image quality, providing clearer and more detailed visualization of retinal layers. A key addition is AreaAssist, a tool that automates the measurement of color-based retinal areas.
Lumenis launched OptiLIFT, a proprietary Dynamic Muscle Stimulation technology (DMSt) for toning facial muscles to address lower lid laxity and impaired blinking without the need for surgery. Now available in the United States, OptiLIFT utilizes DMSt to restore muscle tone, resulting in improved function of the lower eyelid and blinking quality.
Haag-Streit launched the METIS 900. The new ophthalmic microscope system brings Haag-Streit’s optics into the operating room, providing sharp clarity and precision during ophthalmic surgeries. Featuring a stable coaxial red reflex, METIS delivers sharp visualization, and the system’s optimized optics provide an accurate color reproduction, high light transmission, and a large depth of field, the company said.
DigitalOptometrics introduced its autonomous slitlamp with remote control capabilities. The slitlamp can acquire ultra-high resolution, whole-cornea, and anterior segment images with sharp quality, including detailed views of the conjunctiva and lens. The slitlamp allows a staff member or remote doctor to capture images and video, replicating traditional complete anterior segment evaluations while enabling reliable, repeatable results. OM
