Regenxbio Reports Initial Data from Phase II AAVIATE Trial of RGX-314
Regenxbio announced initial data from the ongoing Phase II AAVIATE trial of its gene therapy RGX-314 for the treatment of wet age-related macular degeneration using in-office suprachoroidal delivery, presented at the Retina Society 54th Annual Scientific Meeting. AAVIATE is a multicenter, open-label, randomized, active-controlled, dose-escalation trial that will evaluate the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314 using the SCS Microinjector. Read more.
iCare Announces FDA Approval of Eidon Ultra-widefield Lens Module
The Eidon Ultra-Widefield Lens module from iCare USA received FDA 510(k) approval for distribution in the United States. The ultra-widefield module enables the capture of 120-degree images of the retina in a single shot or up to 200 degrees with its expanded Mosaic function. The company says its image quality enables the detection of small details and signs of pathologies from the center to the periphery. The ultra-widefield lens module can be retrofitted to most Eidon fundus imaging systems.
Essilor Introduces Vision-S 700 Refraction Station
Essilor introduced the Vision-S 700 Refraction Station to increase the speed of refraction and “streamline the process with smart tests and algorithms.” The company says it offers a compact design, wider field of vision, and customizable options, among other features. Learn more.
New Testing Module for M&S Clinical Trial Suite
M&S Technologies today announced the “first of six new enhancements” to its Clinical Trial Suite (CTS), the DVA-5000 for Clinical Trial ETDRS and Contrast Sensitivity Function testing. The company says the new dedicated product specifically addresses the needs of glaucoma and retina trial sponsors and researchers. Read more.
Miru 1day Upside Lens Arrives
Menicon America announced the launch of Miru 1day UpSide, a silicone hydrogel daily disposable lens that uses what the company calls “SmartTouch” technology in its packaging. The company says the packaging always presents the lens with the convex side up for ease of handling and to reduce contamination. Read more.
Video Journal Entry Available
The Video Journal of Cataract, Refractive, & Glaucoma Surgery’s third video entry, titled “Celebrating the Producers!” with guest host Robert Osher, MD, is available for viewing. Watch the video.
Aerie to Report AR-1105 Data at ASRS Annual Meeting
Aerie Pharmaceuticals announced that topline results from the AR-1105 (dexamethasone intravitreal implant) Phase II clinical trial in patients with macular edema due to retinal vein occlusion will be presented at the American Society of Retina Specialists annual meeting (October 8 to 12) in San Antonio. Read more.
J&J Vision to Showcase Veritas Vision System at ESCRS Annual Meeting
Johnson & Johnson Vision will showcase its new Veritas Vision System and clinical data at the European Society of Cataract and Refractive Surgeons annual meeting, October 8 to 11. In addition, 29 scientific communications from company-sponsored studies and investigator-initiated studies will be presented, the company says. View the device in person in Amsterdam at the company’s booth #B14. Read more.
Adverum Presents OPTIC Data
Adverum Biotechnologies presented positive long-term data from the OPTIC clinical trial of ADVM-022 single, in-office intravitreal injection gene therapy in patients requiring frequent anti-VEGF injections for neovascular age-related macular degeneration. Safety and efficacy data from patients followed through two years post-injection, presented at the Retina Society’s annual scientific meeting included: >80 percent reduction in annualized anti-VEGF injection frequency in patients who previously required frequent injections; >50 percent of patients (8/152) after median follow-up of 1.7 years remained entirely free of any supplemental anti-VEGF injection; and robust aflibercept expression levels continued to be sustained through two years after a single injection of ADVM-022, the company says. Read more.
4D Molecular Files IND Application for 4D-150
4D Molecular Therapeutics announced the FDA accepted the Investigational New Drug Application for 4D-150 for wet age-related macular degeneration, enabling the initiation of 4D-150 Phase I/II clinical trial sites. 4D-150 is a dual-transgene, intravitreal gene therapy. Read more.