Ophthalmic Sealants for Corneal Surgeries

Biodendrimers are a new class of well-defined modular biopolymers prepared from monomers that are natural metabolites or known to be biocompatible, that can be custom-designed to provide a unique hydrogel sealant for repairing cornea! wounds. Biodendrimers have several features that make them uniquely attractive for this application including: (1) their chemical composition, physical structure, and molecular weight can be precisely controlled; (2) the dendrimer structure permits diverse and extensive functionalization that facilitates covalent intermolecular crosslinking to form a hydrogel; (3) aqueous solutions of biodendrimer can be crosslinked in situ to form a functional and well-integrated hydrogel sealant using a mild crosslinking reaction; (4) and the mechanical properties of crosslinked biodendrimer sealant can be tuned over a wide range of values by varying the functional groups, molecular weight, dendrimer structure, and concentration. In this SBIR proposal, HyperBranch Medical Technology, Inc. proposes to synthesize and characterize novel dendritic polymers that self-gel to form a sealant, and test their clinical efficacy for repairing corneal perforations and sealing clear corneal incisions - the typical wound created during a cataract procedure. The specific aims of this proposal are: Aim 1. To optimize the self-gelling rate of the dendritic adhesives through changes in dendrimer generation number and concentration. Aim 2. To seal full-thickness 4.1 mm linear corneal lacerations and 3.0 mm clear corneal incisions in enucleated human eyes. Aim 3. To obtain safety data on the sealant formulation necessary for the submission of an Investigational Device Exemption with the FDA, required for human use. Successful completion of these studies in 12 months will lead to Phase II work designed to evaluate the biodendrimer sealant in in vivo rabbit models of clear corneal incisions and corneal lacerations. These studies will be performed in collaboration with Dr. Terry Kim (Duke Eye Center). The objective at HyperBranch Medical Technology, Inc. is to commercialize an ophthalmic sealant that not only could be used in corneal and refractive surgeries, but also have the potential to be used in almost all ophthalmic procedures. Such a sealant would dramatically change the treatment protocols and materials used for wound management in the eye which currently rely on suture methods that have been unchanged for decades.