Navigation Links
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 release therapeutic levels of drugs to the ocular surface over a specified period of time.  The plug depot gradually absorbs and is eliminated from the site, so removal is not necessary after therapy is complete.

"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," stated Amar Sawhney, PhD, President and CEO of Ocular Therapeutix.  "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."

Current ocular drug delivery methods are plagued with disadvantages, including limited penetration and rapid washout. One of the biggest issues, however, is patient non-compliance, as it has been reported that up to 60% of patients do not administer ophthalmic drops as directed.  "Compliance with topical drop treatment regimens is a growing problem as our population ages. We need safe and effective sustained drug delivery methods to manage this issue, as in many surgical and medical clinical cases poor compliance can lead to permanent visual loss or blindness," stated Dr. Richard Lindstrom, founder and attending surgeon of Minnesota Eye Consultants and internationally recognized leader in ophthalmology. "Ocular Therapeutix's sustained drug delivery technology has the potential to solve these issues."

Ocular Therapeutix plans to initiate Phase II clinical trials in 2011 for several indications using the punctum plug technology.  For more information about Ocular Therapeutix and their sustained ocular drug delivery program, please visit www.ocutx.com.

About Ocular Therapeutix, Inc:

Founded in November 2006, Ocular Therapeutix, Inc. is a privately held company based in Bedford, MA focused on the development and commercialization of ophthalmic therapeutic products using its proprietary hydrogel technology. Ocular Therapeutix's first product, the ReSure™ Adherent Ocular Bandage, is CE Mark Approved and under clinical investigation in the United States. Ocular Therapeutix has also developed sustained ocular drug delivery depots using its hydrogel punctum plug technology.


'/>"/>
SOURCE Ocular Therapeutix, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Sylentis Completes Phase I Trial with SYL040012 to Treat Elevated Intraocular Pressure and Glaucoma
2. Tekia Enters Into Distribution Agreement With Fritz Ruck/T-MED, Germany to Market Its Accommodative Intraocular Lens to Treat Presbyopia
3. Sirion Therapeutics Announces Availability of Zirgan(TM) (ganciclovir ophthalmic gel) 0.15% for Ocular Herpes
4. Quark Announces Dosing of the First Patient in Phase I Clinical Trial of its Ocular Neuroprotective Agent, QPI-1007
5. Ocular Therapeutix, Inc. Appoints Two New Board Members
6. ISTA Pharmaceuticals Bepreve(TM) Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies
7. Study of Lacrisert(R) Dry Eye Insert Published in The Ocular Surface
8. Video: Sirion Therapeutics Launches Durezol for Postoperative Ocular Inflammation and Pain
9. SARcode and Sunesis Announce Start of Phase 1 Clinical Trial in Ocular Inflammatory Diseases
10. Apollo Endosurgery Completes First Clinical Case with Newly-Launched FlexShears™ Endoscopic Scissors
11. Randomized Clinical Trial of OrbusNeichs Genous™ Bio-engineered R stent™ in China Completes Patient Enrollment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/10/2017)... , May 10, 2017 CSSi, the ... for the clinical research industry, is proud to announce ... . The new website features both enriched content and ... experience and enhances the company,s already well-established position as ... "After many months of hard work, ...
(Date:5/9/2017)... , May 9, 2017  Demonstrating its commitment ... of directors for the Pharmaceutical Research and Manufacturers ... membership. Biopharmaceutical companies will now have to meet ... to be eligible to join PhRMA. ... board is sending a clear message that being ...
(Date:5/9/2017)... PORTLAND, Ore. , May 9, 2017 /PRNewswire/ ... company that provides technology solutions to improve the ... reported financial results for the first quarter ended ... that our products enable our customers to identify ... them to intervene before events like heart attacks ...
Breaking Medicine Technology:
(Date:5/27/2017)... ... May 27, 2017 , ... From May 21-23, hearing healthcare professionals gained a ... held at the Marriott Syracuse Downtown Hotel in Syracuse, New York. , As ... independent hearing healthcare providers to help them stay ahead in the industry. At the ...
(Date:5/26/2017)... ... May 26, 2017 , ... Mediaplanet is proud to announce the launch ... Today, which will educate readers on how to take care of all aspects of ... is placed on melanoma. Dancing with the Stars professional, Witney Carson, shares her journey ...
(Date:5/26/2017)... ... May 26, 2017 , ... ... CEO 2017 on May 30th and 31st at The Four Seasons Hotel Boston. ... executives in the life sciences, offering exclusive access to key decision makers who ...
(Date:5/26/2017)... ... May 26, 2017 , ... Amir Qureshi, MD is the ... versatile, patient-centric spinal cord stimulation system. The Nuvectra™ Algovita SCS System has been FDA ... to be the first in Arkansas to introduce the most powerful SCS system and ...
(Date:5/26/2017)... ... May 26, 2017 , ... A new analysis of community ... healthiest seniors are located in the Midwest. With the average cost of healthcare rising ... are concerned with both the quality and affordability of where they live. An annual ...
Breaking Medicine News(10 mins):