InSite Vision Incorporated has regained North American development rights to azithromycin ophthalmic solution 2 per cent, trademarked as AzaSite Xtra, from Inspire Pharmaceuticals Inc., a subsidiary of Merck & Co., Inc., known as MSD outside the United States and Canada. AzaSite Xtra, formulated in InSite’s DuraSite topical drug delivery system, is a product candidate intended for the topical treatment of ocular infections.

“We are excited for the opportunity to develop AzaSite Xtra,” said Timothy Ruane, chief executive officer of InSite Vision. “We believe InSite’s capabilities as a nimble, efficient drug developer will allow us to speed the development of AzaSite Xtra.”

Under the terms of the agreement, a joint development committee composed of representatives from both companies will oversee development and submission of applications for regulatory approval in the USA and Canada for AzaSite Xtra. Merck retains an option to acquire AzaSite Xtra for a one-time payment and royalties on any product sales.

In 2007, Insite Vision licensed exclusive rights to commercialize AzaSite and AzaSite Xtra for ocular infections in the United States and Canada to Inspire Pharmaceuticals (subsequently acquired by Merck in May 2011).

AzaSite (azithromycin ophthalmic solution) one per cent is indicated for the treatment of bacterial conjunctivitis in patients one year and older caused by the following organisms: CDC cornyeform group G, haemophilus influenzae, staphylococcus aureus, streptococcus mitis group, and streptococcus pneumoniae. AzaSite is formulated using InSite Vision’s proprietary DuraSite drug delivery technology that extends the duration of drug retention on the surface of the eye. AzaSite Xtra is a higher dose (2.0 per cent) of azithromycin ophthalmic solution formulated in DuraSite and being developed for the topical treatment of ocular infections. InSite Vision has previously completed all formulation/stability data and all GLP toxicology work to support global Investigational New Drug application filings. AzaSite Xtra has patent protection into 2027, with additional applications filed or pending.

InSite Vision is advancing new ophthalmologic products for unmet eye care needs based on its innovative DuraSite platform technologies.