Lantibio Inc. and TRB Chemedica have signed a licensing agreement with a subsidiary of Alcon Inc. to develop, market, and manufacture a product for dry eye syndrome in the United States.
Chapel Hill, NC, and Valais, Switzerland-Lantibio Inc. and TRB Chemedica have signed a licensing agreement with a subsidiary of Alcon Inc. to develop, market, and manufacture a product for dry eye syndrome in the United States.
The product consists of a TRB-patented formulation containing sodium hyaluronate that a subsidiary of Lantibio is studying in the United States under an investigational new drug application (NDA). An ongoing multicenter phase III pivotal study is being conducted under the FDA's Special Protocol Assessment program. Lantibio expects to file a new drug application (NDA) for the product as a treatment for dry eye syndrome next year.
Under the terms of the agreement, Lantibio will conduct the development program and filing of the NDA, whereas Alcon will assume responsibility for subsequent marketing, sales, and manufacturing for the U.S. market. Terms of the agreement include up-front and development milestone payments; additionally, Alcon will pay royalties on sales of the approved product to Lantibio and TRB.
"TRB Chemedica is pleased to be associated with Alcon and Lantibio through the signature of this licensing agreement," said Dr. Guido DiNapoli, founder and owner of TRB Chemedica.