Ocular Therapeutix, Inc. announced today that it has received IDE approval from the U.S. Food and Drug Administration to conduct a pivotal clinical trial with ReSure Sealant, a proprietary synthetic hydrogel polymer for ophthalmic use over clear corneal incisions.

The randomized, parallel-arm clinical trial will test the safety and efficacy of the device, relative to sutured closure, for prevention of postoperative fluid egress on clear corneal incisions following cataract or intraocular lens placement surgery. The trial will be conducted at up to 24 sites throughout the United States.

Cataract surgery is the most commonly performed surgery in the United States, with well over 3 million procedures conducted annually. Clear corneal wound leaks are widely thought to be a contributing factor to many post-surgical complications. Presently, ophthalmologists use stromal hydration to close these wounds, however, recent literature has shown that this technique may not be enough to create a watertight seal, and therefore more protection is necessary. “In a time where wound integrity is under scrutiny, this product fills a void where our only option for closure of vulnerable incisions was sutures,” stated Steven Dell, Medical Director of Dell Laser Consultants. “ReSure Sealant could be a huge step forward for protecting our patients’ eyes post-operatively.”

“We are very excited to have developed a robust study with FDA’s input to definitively demonstrate the utility of the ReSure Sealant compared to older methods of incision closure and management in clear corneal cataract surgery,” stated Amar Sawhney, President and CEO of Ocular Therapeutix, Inc. “We look forward to completing the trial and making the ReSure Sealant available to US physicians by next year.”

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 is also using its hydrogel technology for development of sustained ocular drug delivery vehicles, such as absorbable punctum plugs to deliver moxifloxacin for the treatment of bacterial conjunctivitis, and travoprost for the treatment of glaucoma.

About ReSure Sealant:
The ReSure Sealant is a synthetic hydrogel polymer which is applied as a liquid and gels in situ on the ocular surface, creating a soft and lubricious surface barrier. The Sealant is designed to stay on the incision in the immediate post-operative period when wounds are most vulnerable, after which it gently sloughs off in the patient’s tears.

Contact Information:
Scott Corning
Vice President of Marketing and Sales
Phone: 781-357-4000
Email: scorning@ocutx.com

View PDF

Ocular Therapeutix, Inc. announced today that it has closed a $14 million Series D round of financing. The round was led by Ascension Health Ventures of St. Louis, Missouri, with continued participation by existing investors including Polaris Ventures, SV Life Sciences and Versant Ventures.

The funding will be used to support Ocular Therapeutix’s Phase II clinical trials across a variety of therapeutic areas. The first trial will be conducted to reinforce safety and test efficacy of their first sustained drug delivery system, a moxifloxacin-loaded punctum plug. Following, Ocular Therapeutix plans to initiate additional Phase II clinical trials for punctum plugs designed for the management of glaucoma, dry eye, and allergies, which combined represent markets over $3 billion.

“Ocular Therapeutix is developing an exciting platform of products that promises to meet prevalent medical and surgical needs within a variety ophthalmic disorders,” commented Tara Butler, MD, Investment Director at Ascension Health Ventures. “We are excited to be part of such promising technology.”

This financing round comes on the heels of Ocular Therapeutix’s sustained drug delivery proof of principle study, in which their moxifloxacin-loaded punctum plug achieved 100% retention in all patients as proven via tear fluid testing. Additionally, the plug demonstrated sustained and favorable levels of moxifloxacin throughout the 10-day treatment period.

“The support we are receiving from current and new investors highlights the success of our proof of principle study and our drug delivery platform technology as a whole” commented Amar Sawhney, President and CEO of Ocular Therapeutix. “We look forward to the continued development and success of this program.”

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 commercially available outside the United States. Ocular Therapeutix has also developed sustained ocular drug delivery depots using its hydrogel punctum plug technology, of which it plans to enter Phase II clinical trials in 2011.

About Ascension Health Ventures:
Ascension Health Ventures was launched in 2001 as a wholly-owned subsidiary of Ascension Health. AHV’s role has been to construct and manage a strategic portfolio of investments that deliver a venture investment return, have the potential to transform the healthcare industry and significantly enhance the quality of patient care. CHV II, LP, a limited partnership between Ascension Health, Catholic Health Initiatives, Catholic Health East and Catholic Healthcare West, has been formed to expand this strategic investment initiative to other Catholic healthcare systems. AHV is the general partner of CHV II, LP.

View PDF

Bedford, MA -

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  development.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.

Corporate Communications:

Scott Corning
Director of Global Marketing
Ocular Therapeutix, Inc.
36 Crosby Drive, Ste 101
Bedford, MA 01730 http://www.ocutx.com info@ocutx.com

View PDF

Mr. Haffey was most recently President and CEO of NDO Surgical, a medical technology company dedicated to the development of innovative endoscopic technologies for gastrointestinal diseases. Prior to this position, he joined IntraLase Corp. as Vice President, Business Development. With over 10 years experience in medical technology, Haffey has a proven track record of successfully launching emerging medical technology and medical device companies. Additionally, he has successfully helped three of his former companies through acquisition including NDO Surgical and Intralase. “I am delighted to be joining the world-class team at Ocular Therapeutix and look forward to helping the company achieve world-class business results” said Haffey.

“We are extremely fortunate to add industry veterans such as Bernie and Dan to our board.  While Bernie brings commercial leadership and expertise particularly in the refractive and corneal areas, Dan has deep expertise in ophthalmic pharmaceutical and drug delivery. Their addition to our team will be key as we move forward towards commercialization of the I-ZIP bandage in the US and as we build our drug delivery programs”, said Amar Sawhney, President and CEO of Ocular Therapeutix. The appointment of Mr. Haffey and Mr. Myers increases the number of Ocular Therapeutix directors to seven. Board members also include Amar Sawhney, Fred Khosravi of Access Closure, Inc., Charles Warden of Versant Ventures, Sam Wu of SV Life Sciences, and Alan Crane of Polaris Ventures.

About Ocular Therapeutix, Inc:

Ocular Therapeutix, Inc. is a privately held company based in Waltham, MA focused on the development and commercialization of ophthalmic therapeutic products using its proprietary hydrogel technology. The company was founded in November 2006. The I-ZIP Adherent Ocular Bandage is CE Mark approved and the I-ZIP Ocular Bandage is under clinical investigation in the United States.

I-ZIP is a registered trademark of Ocular Therapeutix, Inc.

View PDF

I-Therapeutix, Inc. announced today that it has changed its corporate name to Ocular Therapeutix, Inc. Amar Sawhney, President and CEO-stated “the Company’s new name more clearly articulates our mission in the ophthalmic marketplace as we pursue FDA clearance for our first product, the I-ZIP^® Ocular Bandage and develop ocular drug delivery therapies.”

Starting today, the company has launched a new website, development.ocutx.com. All business activity moving forward will be conducted using the new name.

About Ocular Therapeutix, Inc.:
Ocular Therapeutix, Inc. is a privately held company based in Waltham, MA focused on the development and commercialization of ophthalmic therapeutic products using its proprietary hydrogel technology. Ocular Therapeutix is also developing sustained ocular drug delivery vehicles utilizing its proprietary hydrogel polymer technology. The company was founded in November, 2006. The I-ZIP Adherent Ocular Bandage has already gained CE Mark approval and the I-ZIP Ocular Bandage is under clinical investigation in the United States.

View PDF

I-Therapeutix announced today that it has closed a $15million dollar Series C financing. The round was led by Polaris Venture Partners inWaltham, MA, with continued participation by existing investors, Versant Ventures and SV Life Sciences.

The proceeds will be used to commercialize I-ZIP^® Ocular Bandage in the United States and to develop sustained drug delivery products for treatment of ophthalmic diseases and ocular infections.

“We are excited about working with I-Therapeutix to meet significant medical needs in ophthalmology. The company offers a combination of an experienced teamwith a successful track record, outstanding technology and product opportunities and a compelling business model,” said Alan Crane, General Partner at Polaris Venture Partners, who will join the company’s Board of Directors.

“In a financing environment that has been challenging for MedTech companies, we welcome the new vote of confidence by Polaris Venture Partners.We look forward to working with our investors to continue building a solid ophthalmic company,” commented I -Therapeutix President and CEO, Amar Sawhney.

About I-Therapeutix, Inc:
I-Therapeutix, Inc. is a privately held company based inWaltham,MA focused on the development and commercialization of ophthalmic therapeutic products using its proprietary hydrogel technology. I-Therapeutix is also developing sustained ocular drug delivery vehicles utilizing its proprietary hydrogel polymer technology. The company was founded in November, 2006. The I -ZIP Ocular Bandage has already gained CEMark approval and is undergoing pivotal clinical investigation in the United States.

About Polaris Venture Partners:
Polaris Venture Partners is a partnership of experienced investors, operating executives and entrepreneurs. The firm’s mission is to identify, invest in and partner with seed, early stage, and middle
market businesses with exceptional promise and help them grow into market-leading companies. Polaris invests in businesses across a number of markets including life sciences, digital media, technology, consumer, and enertech. The firm has over $3 billion under management, more than 20 investment professionals, and current investments in more than 115 companies. Polaris-backed successes in life sciences include Adnexus (sold to Bristol-Myers Squibb), Advanced Inhalation Research (sold to Alkermes), Alnylam Pharmaceuticals (ALNY), Glycofi (sold toMerck), Momenta Pharmaceuticals (MNTA), and TransformPharmaceuticals (sold to Johnson & Johnson). Current and former portfolio companies in technology, digital media and consumer include: Akamai Technologies, Allaire, Art.com, Athletes’ Performance, HealthCentral Network, JibJab, LogMeIn, Powersoft, Quantcast, Solidworks, TechTarget and WordPress.

View PDF

I-Therapeutix, Inc. announced today that Mr. Richard Packard and Dr. Daniel Calladine from the Prince Charles Eye Unit, King Edward VII Hospital, Windsor, UK, performed the first ophthalmic surgeries in Europe with the company’s CE Mark approved I-ZIP® Adherent Ocular Bandage. All phacoemulsification cataract surgeries were performed under topical anesthesia by Mr. Packard. Patients received a foldable IOL with wound-assisted implantation through a 2.2 mm clear corneal incision . No stromal hydration or sutures were used prior to application of the I-ZIP Bandage.

“In a previous clear corneal incision architecture study, we showed that low intra-ocular pressure (IOP) in the immediate postoperative period is associated with incision architectural features that
suggest lower structural integrity. All I-ZIP patients had well formed anterior chambers and the incisions were observed with complete coverage of I-ZIP postoperatively,” said Mr. Packard. Patients
were comfortable with normal tearing.

The I-ZIP Adherent Ocular Bandage is a synthetic hydrogel composed of approximately 90% water that can be applied to cornea, sclera and conjunctiva. The hydrogel bandage is applied as a liquid which then polymerizes in situ, forming a soft, adherent, protective barrier over the ocular incision. I-ZIP Bandage is intended to remain on the ocular surface during the normal reepithelialization process and subsequently slowly sloughs off into the tears. I-Therapeutix is currently conducting a U.S multi-center pivotal study for the I-ZIP Bandage.

About I-Therapeutix, Inc:
I-Therapeutix, Inc. is a privately held Company based in Waltham, MA focused on the development and commercialization of ophthalmic therapeutic products using its proprietary hydrogel technology. I-Therapeutix is also developing sustained ocular drug delivery vehicles utilizing its proprietary hydrogel polymer technology. The company was founded in November, 2006 and is funded by several leading venture capital groups.

View PDF