Eyenovia and SGN Nanopharma to Develop Dry Eye Treatment

Eyenovia and SGN Nanopharma have announced a new collaboration to develop a treatment for chronic dry eye disease. Eyenovia, known for its two FDA-approved products and a late-stage asset in pediatric progressive myopia, will work with SGN Nanopharma to develop a cyclosporine formulation using SGN’s Micellar Nanoparticle Platform (MNP) and Eyenovia’s Optejet® dispenser.

Development and FDA Consultation

The partnership aims to validate the manufacturability of this novel drug-device combination product to support clinical testing. Following this validation, the companies plan to consult with the FDA to discuss the clinical development process.

Market Potential and Current Treatments

Independent sources estimate that chronic dry eye disease affects up to 35 million people in the U.S., including a third of all diabetics, with around 16 million having a formal diagnosis. The current standard of care involves cyclosporine, an immune inhibitor that reduces inflammation and aids tear fluid production. The U.S. market for dry eye treatments is valued at approximately $3 billion annually, with $2.35 billion attributed to cyclosporine-based therapeutics.

Advantages of MNP Cyclosporine and Optejet® Dispenser

Dr. Navdeep Jaikaria, Chairman & CEO of SGN Nanopharma, highlighted the efficacy of their MNP Cyclosporine, stating, “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. 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.”

Addressing Limitations of Current Treatments

Michael Rowe, CEO of Eyenovia, addressed the limitations of current treatments, stating, “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. 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.”