Presbia, which makes the Flexiview Micro-Lens corneal implant to treat presbyopia, registered with the SEC for an initial public offering of up to $90 million worth of stock.
The Flexiview Micro-Lens is designed to be inserted into a pocket created in the cornea using a laser. The pocket seals itself, holding the 3mm-diameter lens in the center of the visual axis. The 10-minute procedure is reversible and does not require general anesthesia, according to Presbia’s website.
Presbia won CE Mark in the European Union for the Flexiview Micro-Lens in 2009 and has it on the market in about 40 countries. Some 450 of the devices have been implanted outside the U.S., according to a regulatory filing.
The Irvine, Calif.-based company is running a phased clinical trial in the U.S. ahead of an application for pre-market approval from the FDA, according to the filing. The federal watchdog agency granted an investigational device exemption for the trial late last year, Presbia said.
The 1st phase of the trial will involve up to 75 patients at 6 U.S. sites, collecting 6-month data on at least 50 patients. That data will back an interim safety report to supplement the IDE; assuming the DA OKs the device’s safety profile, the 2nd stage of the trial will expand to an additional 337 subjects at up to 30 U.S. sites, the company said.
Those patients will be tracked for 3 years, with a PMA application based on 24-month data from at least 300 patients, Presbia said. The company is aiming to begin enrollment for the trial during the 2nd quarter, with the 6-month safety data submission coming during the 1st quarter of 2015, according to the filing. Enrollment in the 2nd phase of the trial, assuming a green light from the FDA, is expected during Q2 2015, Presbia said.
"We are targeting submission of our PMA to the FDA with 24-month data on 300 subjects in 1st first quarter of 2018. We are targeting submission of the 36-month data to the FDA in the 1st quarter of 2019. We are also targeting PMA approval of our Micro-Lens in the 1st quarter of 2019," according to the filing.
