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Ocular Therapeutix Completes Proof of Principle Study with Moxifloxacin-Loaded Punctum Plugs
Date:10/12/2010

BEDFORD, Mass., Oct. 12 /PRNewswire/ -- Ocular Therapeutix, Inc. announced today the completion of a successful Proof of Principle clinical study with their novel sustained drug delivery moxifloxacin punctum plug.

The study was a single-site, single-armed, single-dose study in which ten patients received the punctum plug immediately following cataract surgery and were evaluated over a 10-day period. Primary outcome measures were plug retention and moxifloxacin levels above the minimum inhibitory concentration (MIC) to stop growth in various strains of bacterial conjunctivitis.

The moxifloxacin punctum plug achieved 100% retention in all 10 patients as proven via tear fluid testing.  Pharmacokinetic data demonstrated that tear sample drug levels were maintained between 2,000 and 3,000 ng/ml over a 7 day period. These levels were well above MIC90, the concentration necessary to inhibit bacterial growth of staphylococcus aureus, staphylococcus epidermidis, and streptococcus pneumonia (</= MIC90 = 250 ng/ml).  No adverse events were reported, and there were no ocular complaints outside of normal post-cataract symptoms.

Principal Investigator for the study, Dr. Soon Phaik Chee of the Singapore National Eye Centre in Singapore, commented that "Ocular Therapeutix's moxifloxacin punctum plugs were easy to use and insert.  In addition to the fact that the plugs were retained and released favorable and sustained levels of moxifloxacin, I was impressed at the patients' level of comfort – not one of the patients complained of foreign body sensation or discomfort in relation to the plugs following surgery."

The innovative platform technology uses Ocular Therapeutix's proprietary and patented polyethylene glycol (PEG) hydrogel to encase drug-loaded polylactide-co-glycolide (PLGA) microspheres.  After insertion, the plugs gently expand upon contact with moisture providing a universal fit, and releas
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SOURCE Ocular Therapeutix, Inc.
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