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Sustained release punctum plug completes initial proof-of-principle testing
BEDFORD, Mass. — An antibiotic-containing punctum plug has moved one step closer to clinical trials after completion of a proof-of-principle study.
Ocular Therapeutix has completed a single-site, single-arm, single-dose study of 10 patients implanted with its novel moxifloxacin punctum plug, the company announced in a press release. After 10 days of follow-up from time of insertion (immediately following cataract surgery), 100% of plugs were successfully retained, which was the primary outcome of the study.
Pharmacokinetic testing demonstrated that drug levels were maintained between 2,000 ng/mL and 3,000 ng/mL, which is well above the MIC90 level required to inhibit growth of well-known bacterial insults such as Staphylococcus aureus, S. epidermidis and Streptococcus pneumoniae, according to the release.
“The platform is extremely versatile and compatible with a variety of prescription medications for numerous ophthalmic diseases. Additionally, we can tailor the material for different treatment periods — from days to months — dependent on the disease,” Amar Sawhney, PhD, president and CEO of Ocular Therapeutix, said in the release. “The success of this trial is a validation of our technology platform, and we are moving forward with this technology for other applications including glaucoma, allergies and dry eye.” – by Bryan Bechtel