Novartis Reports Positive Topline Results From Second Phase III Trial of Beovu
Novartis announced positive findings from the Phase III KESTREL study, which assessed the efficacy and safety of Beovu (brolucizumab) 3 mg and 6 mg in diabetic macular edema. Following KITE, KESTREL is the second Phase III study of Beovu in DME. The recent trial met its primary endpoint of non-inferiority in change in best-corrected visual acuity from baseline of Beovu 6 mg to aflibercept 2 mg at year one. And it also met its key secondary endpoint of non-inferiority in average change in BCVA of Beovu 6 mg to aflibercept 2 mg over week 40 through week 521. (Beovu 6 mg is the marketed dose for wet AMD.)
Regenxbio Announces Dosing of First Patient in Phase II ALTITUDE Trial
Regenxbio announced the first patient was dosed in ALTITUDE, a Phase II trial to evaluate the suprachoroidal delivery of RGX-314 using the SCS Microinjector for the treatment of diabetic retinopathy. The trial is expected to enroll approximately 40 patients with DR across two cohorts. Patients will be randomized to receive RGX-314 vs. observational controls at a 3:1 ratio, and two dose levels of RGX-314 will be evaluated. The primary endpoint is the proportion of patients that improve in DR severity based on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at 48 weeks. Read more.
FDA Accepts Rezolute’s IND Application for RZ402
Rezolute announced the FDA accepted its Investigational New Drug application for RZ402, an orally available plasma kallikrein inhibitor that is in development for the treatment of diabetic macular edema. The company expects to initiate a Phase I, first-in-human clinical study with RZ402 in the first quarter of 2021. The company says RZ402, by inhibiting the formation of kallikrein, blocks the pro-inflammatory, pro-coagulant and fluid-leakage cascade triggered by up-activation of the contact activation system in the setting of DME and other vascular-mediated diseases. Read more.
Bruder Introduces Pre-Surgical Patient Prep Kit
Responding to demand from eye-care professionals, Bruder collaborated with ophthalmic surgeons and comanaging optometrists to develop the Bruder Sx Pre-Surgical Patient Prep Kit. The hygiene products needed by presurgical patients are available in a single, self-contained kit that doctors can provide directly in their practices or via the company’s new online patient portal, specifically designed for presurgical patients. The kit includes the company’s hygienic eyelid cleansing wipes, its hygienic eyelid solution, the Bruder Sx Pre-Surgical Compress and the Bruder Sx Case. Learn more.
Optos Introduces UWF Imaging Advancements
Optos’ line of ultra-widefield imaging devices are offering several advancements:
• The Daytona model has improved optics for visualization across the optomap image and automatic laterality detection to improve image capture time. It also features an updated design and user interface.
• The Silverstone model, which offers optomap-guided swept source optical coherence tomography, includes a Repeat Scan tool for monitoring changes over time, and an Explorer mode to display OCT scan type and location. In addition, auto contrast is available for angiography capture. Learn more about the company.
Verana Health & Partners Announce the Start of MIGS Study
Verana Health announced the start of the Patient-Reported Outcomes for Minimally Invasive Glaucoma Surgery (PRO-MIGS) study with the first participant enrolled. The project, which includes the FDA, UCSF-Center of Excellence in Regulatory Science and Innovation and Stanford University, American Academy of Ophthalmology and American Glaucoma Society as partners, will develop a patient-reported outcome instrument known as the Glaucoma Outcomes Survey that can be used for future FDA submissions for MIGS devices, and may help answer important health-related quality of life questions for patients affected by glaucoma. Read more.
GRF Video Encourages Patients to Visit Eye Doctors During COVID-19
The Glaucoma Research Foundation released a six-minute video designed to encourage glaucoma patients to visit their eye care provider for the care they need during the COVID-19 pandemic. The free video, made with the support of Aerie Pharmaceuticals, is entitled “See You Soon!” and is available for eye care professionals to download and share. Access the resource.
Keeler Opens Portal
Keeler, which specializes in ophthalmic diagnostic, digital, surgical, and clinical products recently launched its Global Portal at keelerglobal.com. Keeler says the new site will allow physicians, technology groups, the ophthalmic industry, and future partners to engage with the company on original equipment manufacturer services, strategic partnerships and product ideas to bring to market. Read More.