MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » pSivida launches Phase III study of its micro-sized eye implant

pSivida launches Phase III study of its micro-sized eye implant

By

pSivida launches Phase III of its drug/device combo for vision loss r

pSivida (NSDQ:PSDV) started recruiting patients in a Phase III U.S. trial for its eyelash-sized drug/device combination, an implant designed to treat ocular swelling that can lead to blindness.

The micro-implant treats uveitis, an inflammation of the middle eye layer that can lead to vision loss. pSivida said the study is the 1st of 2 planned efficacy trials required by the FDA before commercial launch.

The 2 trials are slated to take place at 15 sites in the States and possibly at additional locations internationally. If successful, the company plans to submitting the data in a New Drug Application to the FDA.

Watertown, Mass.-based pSivida also licenses the tiny eye implant to Alimera Sciences (NSDQ:ALIM), which has already begun selling its version of the product, called Iluvien, in 6 countries in Europe.

"We are extremely pleased that our 1st 3 U.S. clinical sites have begun recruiting patients for this trial," said CEO Dr. Paul Ashton in prepared remarks. "We are very optimistic that our micro-insert will be efficacious for the treatment of posterior uveitis with a more favorable risk/benefit profile, fewer side effects and greater ease of administration than Retisert, our current FDA-approved product for the treatment of the same disease."

pSivida recently hit a 52-week high on Wall Street based on speculation from a Seeking Alpha blogger that it’s ripe for an acquisition this year.

In case you missed it

RSS From Medical Design & Outsourcing

  • Medtronic’s recall of HawkOne system is Class I
    The FDA today issued a notice confirming that the recall of Medtronic’s (NYSE:MDT) HawkOne system is Class I, the most serious kind. So far in 2022, the FDA has classified three Medtronic-related recalls as Class I, with the Covidien (part of Medtronic) Puritan Bennett 980 series ventilator and the Synergy Cranial and StealthStation S7 Cranial software receiving the same classification earlier… […]
  • January 2022 Issue: The pandemic tested Metronic’s mettle
      The pandemic tested Medtronic’s mettle: Its CFO explains how How Abbott seeks to improve care, health inequities for people with cardiovascular disease Medtech’s biggest personnel changes in 2021 The top 5 medtech news stories of 2021 Some thoughts for medtech leaders in 2022 Starting our third year of the COVID-19 pandemic, I wonder when… […]
  • Feinstein Institutes researchers develop tiny implantable neurostimulator for mouse studies
    Researchers have developed a novel, fully implantable wireless bidirectional vagus nerve stimulation (VNS) and sensing device for mice. Engineers and researchers at the Institute of Bioelectronic Medicine at The Feinstein Institutes for Medical Research published details about the device and its capabilities in Biosensors and Bioelectronics. They think the device has the potential to transform how… […]
  • MIT team working on all-in-one diabetes management devices
    MIT researchers are touting a platform aimed at helping patients maintain healthy glucose levels by streamlining the diabetes management process. The MIT researchers say it’s hard for people with diabetes to maintain a treatment regimen. Typically at every meal, they need to estimate carbohydrate content, draw blood to measure blood glucose levels, and calculate the… […]
  • Element expands life sciences testing business with pharma, biotech capabilities
    Element Materials Technology recently announced that with the completed acquisition of JMI Laboratories in 2021, it has built out its life sciences testing capabilities for the pharmaceutical and biopharmaceutical industries. The acquisition added more than 1,000 experts in 23 facilities in North America and Europe and marked a strategic shift for the London-based company to… […]
  • Team Technologies acquires consumable medical device manufacturer iiMed
    Team Technologies recently announced that it acquired consumable medical device manufacturer iiMed Medical Solutions for an undisclosed amount. The acquisition is the fourth purchase since Clearlake Capital Group invested in the company in 2018. It is the eighth transaction completed by the company since 2012. Nearshore specialty manufacturer iiMed makes FDA Class I and Class… […]
  • P-Duke Technology is selling dc/dc converters for medical
    P-Duke Technology is promoting its MPS and MPH series of medical dc/dc converters. The MPS and MPH series comply with Medical EN60601-1 and I.T.E. EN 62368-1 certifications, according to the company. They provide 2W and 3.5W output power, 2:1 input range, regulated 5, 9, 12, 15, 24, ±12, ±15 VDC output voltage, and both DIP16… […]
  • Philips backing efforts to reduce CIED infections
    Royal Philips (NYSE:PHG) announced today that it supports the American Heart Association’s efforts to reduce CIED infections. Amsterdam-based Philips offered its support to the initiative to generate awareness among cross-disciplinary specialties and improve survival rates from CIED (cardiovascular implantable electronic device) infections. The company said in a news release that, with its support, the American… […]
  • Democratic senator wants COVID-19 test-makers to lower prices
    Sen. Ed Markey, D-Massachusetts, has sent letters to CEOs of at-home COVID-19 test-makers, asking why tests are selling for as much as $12 apiece. In a letter sent today to Abbott CEO Robert Ford, for example, Markey cited a Reuters story from October 2021 in which British test-maker Mologic said that rapid antigen tests can… […]
  • These medtech companies care a lot about research
    They’re making glaucoma-treating stents, tumor-treating fields, coin-sized CGMs and more. Discover the medtech companies that spend the most on research as a percentage of revenue. The list comes from our annual Big 100 report, which examines the world’s 100 largest medical device companies and ranks them by revenue. (Check out our full Big 100 report… […]
  • Traco Power launches new AC/DC power supplies
    Traco Power (Baar, Switzerland) announced its newest high efficiency, miniaturized ac/dc power supplies: the TPP 180 series for medical and industrial and TPI 180 for industrial. The power supplies measure only 2-by-3-by-1.24 inches in the open frame version — with global safety approvals for medical or industrial markets. They come in16 standard models with single… […]

Leave a Reply