Ocular Therapeutix, Inc., developers of ophthalmic therapeutic products using a proprietary hydrogel technology, has announced that 11 podium and poster presentations, including clinical data on its ReSure Sealant and sustained release dexamethasone, will be presented at the upcoming American Society of Cataract and Refractive Surgery (ASCRS) Annual Symposium in Boston, Massachusetts from April 25-29, 2014.
The ReSure Sealant is the first and only sealant that has been approved by the Food and Drug Administration (FDA) for ophthalmic use, and is now commercial in the United States. The ReSure Sealant is a polyethylene glycol-based (PEG) hydrogel, which is applied as a liquid and turns into a solid gel which adheres to the surface of the eye in less than 20 seconds. It is designed to be a lubricious surface barrier to seal incisions immediately during the post-operative period. As the wounds begin to heal, the gel gently sloughs off in the patient’s tears. Use of the ReSure Sealant was shown to more effectively seal wounds than sutures and to have significantly fewer adverse events than traditional sutures, as demonstrated in its US pivotal clinical trial. The sealant is easy to apply, comfortable for the patient, and requires no removal following surgery.
In March 2014, Ocular Therapeutix announced the start of its Phase 3 clinical program to evaluate the safety and efficacy of the company’s sustained release dexamethasone (OTX-DP) product candidate, a one-time, bioabsorbable intracanalicular corticosteroid for post-operative inflammation and pain following ophthalmic surgery. OTX-DP is designed to be easily inserted following cataract surgery into the punctum and to be comfortable for the patient. The plug is designed to release the steroid to the ocular surface for up to 30 days without resulting in the long-term increases in intraocular pressure that are associated with topical drops. Phase 2 results will be presented at the symposium.
Details of the podium presentations at the ASCRS Annual Symposium:
Saturday April 26, 2014
- Comparison of Intraoperative Wound Leakage in Clear Corneal Incisions After Closure With Stromal Hydration, Suture, or Ocular Sealant. Author: Samuel Masket, MD, 2:07p.m. EST, Room: 151A.
- Single-Center Results of Ocular Sealant Evaluation Compared With Suture in Preventing Clear Corneal Incision Leakage After Cataract Surgery. Author: Charles D. Reilly, MD, 2:12p.m. EST, Room 151A.
- Evaluation of Ocular Sealant for Prevention of Fluid Egress After Cataract Surgery: Multicenter Randomized Pivotal Trial. Author: Terry Kim, MD, 2:17p.m. EST, Room 151A.
Sunday April 27, 2014
- Multi-Center Study of Safety and Efficacy of Toric IOL and Wound Closure Method After Cataract Surgery. Author: Stephen S. Lane, MD, 2:11p.m. EST, Room 152.
- Multi-Center Evaluation of Safety and Efficacy of Sustained-Release Dexamethasone After Cataract Surgery. Author: Michael J. Endl, MD, 3:08p.m. EST, Room 152.
Monday April 28, 2014
- Single-Site Evaluation of Ocular Sealant Compared With Suture for Prevention of Clear Corneal Incision Leaks After Cataract Surgery. Author: John A. Hovanesian, MD, 8:27a.m. EST, Room 152.
- Evaluation of Sutures for Wound Closure of Clear Corneal Incisions With Wound Leaks. Author: Michael B. Raizman, MD, 8:32a.m. EST, Room 152.
- Multi-Center Evaluation of Propensity for Wound Leaks in Immediate Postoperative Period. Author: Jeffrey H. Levenson, MD, 8:37a.m. EST, Room 152.
- Evaluating Replaceable Hydrogel Punctum Plugs as Placebo Vehicles for Sustained Drug Delivery. Author: Robert J. Noecker, MD, 1:06p.m. EST, Room 155.
Details of the poster presentations at the ASCRS Annual Symposium:
Saturday, April 26 – Tuesday, April 29
- Single-Center Results of Safety and Efficacy Evaluation of Sustained Dexamethasone After Cataract Surgery. Author: Thomas R. Walters, MD. Location: Computer Kiosks, BCEC
- Multicenter Evaluation of Safety and Efficacy of Ocular Sealant After Cataract Surgery With Premium IOL. Author: Y Ralph Chu, MD. Location: Computer Kiosks, BCEC
Information regarding podium and poster presentations will be available at the Ocular Therapeutix booth, #121.
About Ocular Therapeutix, Inc.
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 Sealant, was FDA approved in January 2014 for the prevention of post-operative fluid egress following cataract surgery. Ocular Therapeutix is in clinical trials for drug-eluting intracanalicular plugs for treatment of post-operative pain and inflammation and glaucoma, and is developing sustained release injectable anti-VEGF drug depots for back-of-the-eye diseases.
Any statements in this news release about future expectations, plans and prospects for Ocular Therapeutix constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements. Ocular Therapeutix anticipates that subsequent events and developments may cause its views to change. However, while Ocular Therapeutix may elect to update these forward-looking statements in the future, it specifically disclaims any obligation to do so.
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