IN BRIEF...

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. 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 FDA approval. The decision gives the technology simultaneous approval for all 3 major indications—myopia, hyperopia and mixed astigmatism. When performing LASIK for myopia at 500 Hz, the laser can intra-operatively ablate 1 diopter in 1.3 seconds. The graphic user interface supports fast treatment procedures, and the touchscreen can be flexibly positioned.

Bausch + Lomb announced the US launch of Arise, a lens fitting system that uses intelligent, cloud-based technology to streamline the orthokeratology lens design process. Arise syncs directly with topographers to create precise lens designs in seconds to treat myopia. These lenses include the first orthokeratology lens design with toric peripheral curves approved by the FDA to treat myopia overnight.

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.

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.

Topcon Healthcare, RadiusXR, and Glaukos Corp. announced a collaboration and the launch of RadiusXR’s new wearable vision testing platform—Inspire. This collaboration unites RadiusXR’s visual field platform and Topcon’s global leadership in robotic diagnostics and digital health care solutions with Glaukos’ commitment to expanding patient access by democratizing the diagnosis of ophthalmic diseases such as glaucoma.

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). Susvimo is the first FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections, the company said. It 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 (AMD). The decision provides physicians and patients with greater flexibility in managing
the disease.

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.

Norlase announced the commercial launch/FDA 510(k) clearance of LYNX, a laser indirect ophthalmoscope with integrated pattern-scanning capabilities. The laser and pattern module is built into the ergonomic headset, eliminating the need for an external laser source.

The FDA approved Encelto (revakinagene taroretcel-lwey; Neurotech Pharmaceuticals), an ocular insert that represents the first treatment for Macular Telangiectasia type 2 (MacTel). Encelto is an encapsulated cell therapy that is implanted in
the vitreous.

ANI Pharmaceuticals announced the FDA approved an expanded label for Iluvien (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). The approval also includes other updates to the label including to the Warnings and Precautions section.

Atsena Therapeutics announced the FDA has granted Fast Track designation for ATSN-201 for the treatment of X-linked retinoschisis (XLRS). ATSN-201, a best-in-class gene therapy product candidate, leverages AAV.SPR, the company’s novel spreading capsid, to achieve therapeutic levels of gene expression in photoreceptors of the central retina while avoiding the surgical risks of foveal detachment.

Sydnexis Inc. announced the FDA has accepted its new drug application (NDA) for SYD-101 and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025. If approved, SYD-101 would be the first and only pharmaceutical option for the treatment of progression of pediatric myopia in the United States, the company said.

OKYO Pharma Limited announced the filing of its application for Fast Track designation with the FDA for urcosimod for the treatment of neuropathic corneal pain, a severe ocular condition without an FDA-approved therapy. In a phase 2, double-masked trial to treat dry eye disease, urcosimod showed statistical significance in multiple endpoints.

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. 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.

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. OptiLIFT utilizes DMSt to restore muscle tone, resulting in improved function of the lower eyelid and blinking quality.

DigitalOptometrics’ new autonomous slitlamp with remote control capabilities can acquire ultra-high resolution, whole-cornea, and anterior segment images, including detailed views of the conjunctiva and lens. The slitlamp allows a staff member/remote doctor to capture images and video, replicating traditional complete anterior segment evaluations while enabling reliable, repeatable results without requiring specialized training.

Seonix Bio announced the US launch of SightScore, a clinical polygenic risk-testing service for primary open-angle glaucoma. SightScore uses a saliva test to identify individuals at high risk for glaucoma, enabling earlier diagnosis/intervention as well as more personalized treatment. The test can also identify low-risk individuals who may benefit from less frequent monitoring.

Harrow has introduced Vevye Access for All, an initiative that guarantees access to Vevye (cyclosporine ophthalmic solution) 0.1% for eligible patients and health plans for $59, ensuring that every patient can affordably start treatment without delay. The program is now available through Harrow’s PhilRx mail-order pharmacy partner. Harrow also announced the execution of a 5-year strategic supply and development agreement for Triesence (triamcinolone acetonide injectable suspension) 40 mg/mL, for visualization during vitrectomy and the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids.

Regeneron Pharmaceuticals reported results from the Phase 3 QUASAR trial investigating Eylea HD (aflibercept) Injection 8 mg for the treatment of macular edema following retinal vein occlusion, including central, branch and hemiretinal vein occlusions. The trial met its primary endpoint at 36 weeks, with both groups of Eylea HD patients dosed every 8 weeks achieving non-inferior visual acuity gains compared to those receiving Eylea (aflibercept) Injection 2 mg dosed every 4 weeks. OP