09.07.2015 14:00:00

Presbia Reaches the Halfway Mark in Second Stage Enrollment in the US FDA Pivotal Study

Presbia PLC (NASDAQ: LENS), an ophthalmic device company that has developed and is currently marketing the Presbia Flexivue Microlens™, a revolutionary optical lens implant for treating presbyopia today announced that it has treated over 50% of subjects in the second stage enrollment of its pivotal study.

Presbia received FDA approval to commence the second stage of its pivotal study in February, and continues enrollment of subjects at eleven investigational sites across the United States. Subjects treated as a part of stage one of the pivotal study are being actively monitored.

"The second stage enrollment of our pivotal study is progressing on schedule, moving forward towards our target of obtaining FDA approval,” said Todd Cooper, President and CEO of Presbia.

Forward-Looking Statements

Information provided and statements contained in this press release that are not purely historical are forward-looking statements. Such forward-looking statements only speak as of the date of this press release and Presbia assumes no obligation to update the information included in this press release. Statements made in this press release that are forward-looking in nature may involve risks and uncertainties. Accordingly, readers are cautioned that any such forward-looking statements are not guarantees and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Although Presbia believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Unless otherwise required by law, Presbia also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made in this press release.

About Presbia

Presbia PLC (NASDAQ:LENS) is an ophthalmic device company that has developed and is currently marketing the presbyopia-correcting Presbia Flexivue Microlens™, a miniature lens that is implanted in a corneal pocket created by a femtosecond laser. The Presbia Flexivue Microlens™ has received a CE mark for the European Economic Area, allowing the lens to be marketed in over 30 countries across Europe. A staged pivotal U.S. clinical trial for the Presbia Flexivue Microlens™ commenced in 2014.

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