DEVELOPMENT OF SUTURELESS AMNIOTIC MEMBRANE GRAFT

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DESCRIPTION (provided by applicant): Ever since Pl's first report in 1995 to reintroduce the use of human preserved amniotic membrane for ocular surface reconstruction, there has been a surge of interest in its ophthalmic uses as evidenced by the increasing numbers of papers published. Collectively, these studies have shown that amniotic membrane transplantation is effective in facilitating epithelial wound healing, and reducing stromal inflammation, scarring and unwanted new blood vessel formation. In 2001, FDA has formally classified human amniotic membrane as a "Tissue" and not "Device" or "Drug" or "Biologics" when used for ocular surface reconstruction. Using Pl's proprietary method (US Patents Nos. 6,152,142 and 6,326,019), Bio-Tissue, a subsidiary of Tissue Tech, Inc., has distributed more than 6000 amniotic membrane grafts (under the trade name of AmnioGraft) to more than 700 ophthalmic surgeons In USA since 1997. They were used as a permanent graft or as a temporary patch (dressing or bandage) for a variety of ophthalmic indications. In either of these two modes of applications, sutures are used to secure the membrane on patient's eye at a major operating room. The main objective of this SBIR Phase I grant proposal is to develop a "sutureless" AmnioLens based on a recently licensed proprietary right (Provisional Patent No.: 60/365,356). It will be accomplished by the following three Aims. Aim 1: To develop AminoLens by modifying the existing prototypes based on the shape of a conformer to be fitted to cover the corneal and the entire ocular surfaces, respectively. Aim 2: To examine the durability of the manufactured AmnioLens after cryopreservation. Aim 3: To examine the safety of AmnioLens when applied to rabbit eyes (pre-clinical study). Completion of the above three aims will generate sufficient data for IDE submission to FDA so that a clinical trial can be initiated under the support of SBIR Phase II grant. This endeavor will ultimately lead to the commercialization of AmnioLens that can be used as a temporary patch, i.e., dressing or bandage, to treat various difficult ocular surface diseases characterized by poor wound healing, unwanted inflammation and excessive scarring. Because AmnioLens is "sutureless", it can be used in office practices or bedside of Burn or Intensive Care Units to eliminate cumbersome and costly surgical facilities. Furthermore, it will also allow us to test its applicability in other clinical indications in the future.