Eyenovia, Inc. and SGN Nanopharma announced that the companies have entered into a collaboration agreement to develop a treatment for chronic dry eye disease.
Under the terms of the agreement, the companies will work to develop SGN’s Micellar Nanoparticle Platform (MNP) platform-based cyclosporine formulation for use with Eyenovia’s Optejet dispenser.
The companies are currently validating the novel drug-device combination product's manufacturability to support clinical testing and will then schedule a consultation meeting with the FDA to discuss clinical development.
It has been estimated by independent sources that as many as 35 million people are affected by dry eye disease in the U.S., including 1/3 of all diabetics. Of these, approximately 16 million have been formally diagnosed.
The current standard of care treatment for dry eye is cyclosporine, an immune inhibitor that makes it easier for the body to produce tear fluid by inhibiting the underlying inflammation.
Dry eye represents an approximate $3 billion addressable market annually in the U.S., of which approximately $2.35 billion is derived from sales of cyclosporine-based therapeutics.
“Our MNP Cyclosporine was shown to be statistically superior in a head-to-head clinical study versus the current standard of care. The data demonstrates the efficacy of MNP Cyclosporine in as little as four weeks and a lower incidence of side effects such as corneal irritation,” stated Dr. Navdeep Jaikaria, chairman & CEO of SGN Nanopharma. “With the precision dosing afforded by the Optejet dispenser, we believe we can further improve this promising drug's efficacy and tolerability profile. Our ‘drug-device’ combination therapy with Eyenovia has the potential to be the ‘best-in-class’ and to significantly improve patient outcomes and market penetration in this highly underserved dry eye market. We look forward to working with our partners at Eyenovia, and our investors toward this goal.”
“Notwithstanding the widespread use of cyclosporine-based treatments for dry eye disease, currently available formulations have significant shortcomings, including a delayed onset of action of up to 12 weeks and unpleasant side effects that result in significant patient attrition and non-compliance,” stated Michael Rowe, CEO of Eyenovia. “The Optejet dispenser has been shown in prior studies to deliver a therapeutic dose of medication with 80% less drug volume, thereby minimizing exposure to harmful preservatives and improving tolerability. We believe the power of SGN’s MNP platform, when combined with the Optejet, will result in a more efficacious and better tolerated cyclosporine-based treatment that we believe has the potential to become the standard of care in this multi-billion-dollar addressable market.”