The first patients have been treated in Kodiak Sciences Inc.'s phase II DAZZLE trial of anti-VEGF antibody biopolymer conjugate KSI-301 in patients with treatment-naïve wet age-related macular degeneration. At least 368 patients worldwide are expected to enroll in the study. The primary endpoint will be assessed at one year and each patient will be treated and followed for two years.

San Clemente, Calif.-based Glaukos Corp. has finished enrolling patients in its U.S. investigational device exemption (IDE) trial for the Istent Infinite trabecular micro-bypass system, which is intended for standalone use in lowering intraocular pressure (IOP) in refractory glaucoma patients. If all goes as planned, the company is looking to commercially launch the treatment in the U.S. in 2021.

LONDON – There is no evidence for increased mortality in patients receiving paclitaxel-eluting stents and drug-coated balloons (DCBs) to treat peripheral arterial disease, according to the largest real-world safety analysis to date. The findings may come as a relief to many, particularly after a meta-analysis published in December 2018 led to safety warnings and restrictions on the use of coated and drug-eluting devices.

HONG KONG – Hutchison China Meditech Ltd.'s (Chi-Med) is preparing for the next step after surufatinib achieved its primary endpoint in a phase III SANET-ep study in extra-pancreatic advanced neuroendocrine tumors (NETs) in China.

WASHINGTON – Hot on the heels of July's FDA approval of Recarbrio (imipenem, cilastatin and relebactam) in complicated urinary tract infections (cUTIs), Merck & Co. Inc. rolled out pivotal phase III data at the Infectious Disease Society of America's IDWeek 2019 that could support expanding its label to another high-need group, people with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP).

Something of a duel may be shaping up between Menlo Park, Calif.-based Adverum Biotechnologies Inc. with ADVM-022, the phase I gene therapy candidate for wet age-related macular degeneration (AMD) and Regenxbio Inc., of Rockville, Md., with a similar candidate.

The routine application of medical device technology to neurological indications beyond pain remains challenging in all but the most severe patients. Micro-cap Neuronetics Inc. is aiming to change all that with its Neurostar transcranial magnetic stimulation (TMS) system that is noninvasive and used in the physician's office.

William Kaelin, Peter Ratcliffe, and Gregg Semenza have jointly won the 2019 Nobel Prize "for their discoveries of how cells sense oxygen," the Nobel Assembly at Karolinska Institutet announced today.

Investors sorting through NGM Biopharmaceuticals Inc.'s interim results from the fourth and final cohort of the adaptive phase II trial with aldafermin in nonalcoholic steatohepatitis (NASH) may have felt let down when comparing the data to previous cohorts' outcomes. Shares of the South San Francisco-based firm (NASDAQ:NGM) closed Monday at $10.78, having sunk $2.77 or 20.4%.

WASHINGTON – While the vast majority of people infected with respiratory syncytial virus (RSV) muddle through with mild, cold-like symptoms, for infants, the associated bronchiolitis can make it extremely difficult to breathe and feed. Thousands require inpatient care for the infection each year, necessitating hospitals to be built with a winter surge of admissions in mind, driven in large part by RSV in both the very young and old.