Kala Pharmaceuticals touted data today from a Phase III trial of its nanoparticle formulation of loteprednol etabonate as a treatment for inflammation and pain in cataract surgery patients. The KPI-121 1% suspension met both primary efficacy endpoints and secondary endpoints and was well tolerated by the trial’s participants. The Waltham, Mass.-based company’s KPI-121 uses Kala’s mucus-penetrating […]
Clinical Trials
Aeterna shares tumble after cancer-killing agent fails in Phase III trial
Shares in Aeterna Zentaris (NSDQ:AEZS) fell more than -50% this morning after the company said that the Phase III trial of Zoptrex did not meet its primary endpoint in women with locally advanced, recurrent or metastatic endometrial cancer. The ZoptEC pivotal trial was designed to evaluate the safety and efficacy of a hybrid molecule made up […]
Medtech stories we missed this week: April 28, 2017
From FDA and Health Canada approvals to joint ventures, here are medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Joimax Endovapor 2 Joimax announced in an April 26 press release that it has received FDA 510(k) clearance to market its Endovapor 2 Multi-Radio Frequency System. The device generates […]
Artificial pancreas shows promise in pediatric study
A pilot study evaluating an artificial pancreas in children with Type I diabetes found that the device helped kids control their condition, according to researchers at the University of Virginia. The artificial pancreas was developed at the UVA Center for Diabetes Technology and features a smartphone powered by algorithms that wirelessly link to a glucose monitor […]
Boston Scientific looks to lead the drug-eluting PAD market
Angioplasty is not a new procedure – doctors have been widening obstructed arteries with balloons since the 1960s. But for years the medtech industry has been plagued with what Jeff Mirviss, president of Boston Scientific’s interventional peripheral biz, calls the procedure’s Achilles heel: Restenosis. For patients treated with bare balloons, half must have the procedure done again […]
Midazolam nasal spray trial meets primary endpoint in patients with seizure clusters
Proximagen Ltd. said today that its pivotal Phase III trial of intranasal midazolam met its primary efficacy endpoint as a treatment for patients with seizure clusters. The Cambridge-based company said it plans to begin talks with the FDA for a New Drug Application in the 2nd half of this year based on the trial’s findings. […]
Braeburn’s risperidone implant meets primary endpoint in schizophrenia trial
Braeburn Pharmaceuticals said yesterday that a 6-month study of its risperidone implant in patients with schizophrenia or schizoaffective disorder met its primary endpoint. Risperidone, the most commonly-prescribed therapy for schizophrenia, depends on consistent administration, but patients with schizophrenia sometimes stop taking their medication when their symptoms improve. Long-acting, injectable formulations of risperidone are on the market, […]
Mercator enrolls first patient in BTK vascular disease trial
Mercator MedSystems said today that the 1st patient was enrolled in its Tango clinical trial. The trial is evaluating Mercator’s Bullfrog micro-infusion device for the adventitial delivery of temsirolimus below the knee in patients with critical limb ischemia. The Tango trial is the 4th ongoing clinical trial using the Bullfrog device in below the knee applications […]
Alnylam, The Medicines Co., detail Phase III trial for RNA-based heart drug
The Medicines Co. (NSDQ:MDCO) and Alnylam Pharmaceuticals (NSDQ:ALNY) said today that they’ve reached a deal with the FDA over a Phase III trial for the companies’ RNA-based cholesterol-lowering drug, inclisiran. If approved, it would be the 1st RNA-interference therapy on the market. The drug is a part of a new group of drugs called PCSK9 […]
Medtronic touts drug-coated balloon in peripheral artery disease patients
Medtronic (NYSE:MDT) touted data today for its In.Pact Admiral drug-coated balloon in 2 sub-analyses of peripheral artery disease patients in the company’s In.Pact Global Study. The data were presented at the 2017 Charing Cross Symposium in London. Researchers presented 1-year outcomes in patients with complex lesions, as well as outcomes in a subset of patients with […]