WHAT’S NEW IN GLAUCOMA

Alcon completed the acquisition of Ivantis Inc., the developer of the Hydrus Microstent device.

Glaukos submitted a supplemental pre-market approval application to the FDA for the iStent infinite trabecular micro-bypass system.

Luneau Technology launched the Visionix VX650 ocular measuring device with retinal screening. With the push of a button, the operator of the Visionix VX650 can retrieve screening data on the entire anterior and posterior eye segments to identify and detect the early signs of cataracts, glaucoma, retinal and corneal pathologies.

M&S Technologies introduced an enhancement to its Clinical Trial Suite (CTS): the DVA-5000. This enhancement specifically addresses the needs of glaucoma and retina trial sponsors and researchers, and its automated-testing protocols are designed to be more efficient and accurate compared to traditional testing methods.

Marco Ophthalmics and Olleyes entered into a distribution arrangement whereby Marco will add the Olleyes VisuALL S VRP (Virtual Reality Platform) into its existing portfolio of ophthalmic medical devices. The VisuALL is the latest commercially available virtual reality visual field analyzer that can be used in clinical practice to detect glaucoma and to evaluate other eye diseases.

Sight Sciences’ OMNI was cleared by the FDA for canaloplasty followed by trabeculotomy to reduce IOP in adult patients with primary open-angle glaucoma and open-angle glaucoma. Sight Sciences intends to further develop OMNI and seek regulatory clearance for expanded indications.

IN THE NEWS

Alchemy Vision Project announced an updated release of ENTRY, its digital curriculum focused entirely on ophthalmic technician training. The new edition includes a personalized learning roadmap tailored to each technician’s skills and needs, a frequently updated library of lessons, regular live-streamed Deep Dive lessons from industry professionals, quizzes and assignments to support the training needs of eye-care teams across the country.

The Lancet published two papers on the one-year results of four Phase 3 trials for Genentech’s faricimab, a bispecific investigational medicine being studied to treat wet AMD and diabetic macular edema (DME). Across the four studies, about half of eligible faricimab patients were able to go 4 months between treatments in the first year, and approximately three-quarters could go 3 months or longer in the TENAYA and LUCERNE wet AMD studies and the YOSEMITE and RHINE DME studies. Faricimab is under review by the FDA.

Alcon completed the acquisition of Ivantis Inc., the developer of the Hydrus Microstent device. Alcon plans to bring Hydrus Microstent to more international markets and prioritize its ongoing evidence-based research. The company plans to pursue standalone surgery indications for Hydrus Microstent in the United States with clinical trials underway.

C. Light Technologies, a neurotech and AI company that uses retinal eye-tracking to research neurodegeneration and therapeutic efficacy, appointed Lon Dowell as its new chief commercial officer. Dowell brings more than 30 years of experience with global medical device companies to his new role.

Immunocore Holdings plc received FDA approval of KIMMTRAK (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK is the first TCR therapeutic and first bispecific T cell engager (to treat a solid tumor) to receive regulatory approval from the FDA and the first therapy for the treatment of unresectable or mUM to be approved by the FDA.

Omeros Corp. completed the sale of OMIDRIA (phenylephrine and ketorolac intraocular solution) 1.0%/0.3% to Rayner Surgical Group. The transaction was completed pursuant to an Asset Purchase Agreement that was announced in December 2021. Omeros received approximately $126 million in cash at closing.

Keeler entered into a distribution agreement with Avellino to sell AvaGen, the first genetic test to help determine a patient’s risk of keratoconus and the presence of TGFBI corneal dystrophies.