Visus Therapeutics announced today that three novel presbyopia treatments achieved their improvement endpoints in a Phase 2 study. Seattle-based Visus’ Vivid Phase 2 study observed all three of the included investigational candidates achieve the endpoint of three lines of improvement in binocular near visual activity without losing one line of distance vision with a minimum […]
Clinical Trials
FDA authorizes expansion of Fractyl’s pivotal clinical trial for diabetes reversal tech
Fractyl Health announced today that the FDA gave authorization to expand the Revitalize-1 pivotal clinical study of its Revita DMR system. Lexington, Massachusetts-based Fractyl Health (formerly Fractyl Laboratories) can now increase the sample size of the Revitalize-1 trial (formerly Revita-T2Di trial) from 288 to 420. In September, Fractyl activated the 10th clinical site in the […]
Medtronic plans to bring next-gen diabetes tech to FDA this fiscal year, no spinoff planned
Medtronic (NYSE:MDT) confirmed that it anticipates major regulatory steps for its next-generation insulin pump and sensor during this fiscal year. Medtronic’s fiscal years wrap up at the end of April. Speaking on the company’s second-quarter earnings call, Chair & CEO Geoff Martha said Medtronic expects its MiniMed 780G insulin pump system with the Guardian 4 […]
Better Therapeutics completes enrollment in type 2 diabetes study
Better Therapeutics (NSDQ:BTTX) announced that it completed patient enrollment in a study of its digital therapeutic in treating diabetes. San Francisco-based Better Therapeutics’ BT-001 prescription digital therapeutic delivers a novel cognitive-behavioral therapy to patients with uncontrolled type 2 diabetes. According to a news release, the trial for BT-001 exceeded its enrollment target, bringing in 662 […]
7 diabetes treatment innovations to look out for on World Diabetes Day
World Diabetes Day — Nov. 14 — centers around raising awareness for those with diabetes. This year, that aim remains the same, and medical technology companies continue to look for ways to continue improving the management of the metabolic disease. Some of those treatments involve insulin, which was discovered as a treatment for diabetes in […]
Gyroscope Therapeutics to receive investment from Sanofi worth up to $60M
Gyroscope Therapeutics announced today that it received a commitment from Sanofi (NYSE:SNY) to invest up to $60 million. London-based Gyroscope will receive a $40 million investment from Sanofi initially. That $40 million represents a premium to Gyroscope’s previous Series C financing, with the remaining $20 million to be invested contingent on a future qualifying investment […]
Eyenovia enrolls first patient in Phase 3 trial for treating presbyopia
Eyenovia (NSDQ:EYEN) announced today that it enrolled the first patient in the second Phase 3 clinical trial for its MicroLine formulation. New York-based Eyenovia designed its MicroLine proprietary pilocarpine formulation for temporary improvement in near vision (presbyopia). The Vision-2 trial, a double-masked, placebo-controlled, cross-over superiority trial will treat 140 subjects with presbyopia, randomly assigning them […]
Ocular Therapeutix dry eye treatment trial fails to meet primary endpoint
Ocular Therapeutix (NSDQ:OCUL) announced today that its Phase 2 clinical trial for treating dry eye disease (DED) did not meet its primary endpoint. Bedford, Massachusetts-based Ocular Therapeutix’s U.S.-based, randomized, double-masked, multi-center, vehicle-controlled Phase 2 clinical trial evaluated OTX-CSI (cyclosporine intracanalicular insert) for treating DED by measuring signs and symptoms of DED in 140 subjects treated […]
Eli Lilly touts data for tirzepatide compared to insulin glargine for type 2 diabetes
Eli Lilly (NYSE:LLY) announced positive results from a trial comparing tirzepatide to titrated insulin glargine in adults with type 2 diabetes. Indianapolis-based Eli Lilly’s Surpass-4 clinical trial demonstrated that adults with type 2 diabetes and increased cardiovascular (CV) risk experienced superior A1C and body weight reductions from baseline across all three doses of tirzepatide compared […]
Medtronic touts data for MiniMed 780G insulin pump in children
Medtronic (NYSE:MDT) reported positive one-year, real-world clinical data for its MiniMed 780G insulin pump platform in children. Data came from a subset of 3,211 pediatric and adolescent patients (15 years old and below) with type 1 diabetes using the MiniMed 780G system with the Guardian Sensor 3 in Europe. According to a news release, the […]