Potential to Redefine Dry Eye Disease Drug Therapies with EyeSol^®

CyclASol^® and NOV03 address two distinct route causes of dry eye disease. The mode-of-actions are not competitive as they target two different underlying drivers of the disease: inflammation and abnormal lipid layer due to Meibomian gland dysfunction.

NOV03 (perfluorohexyloctane) is a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).
As a unique tear film stabilizer it is designed to prevent excessive tear evaporation and restore tear balance in patients with evaporative DED. Evaporative DED occurs due to Meibomian gland dysfunction leading to a deficient lipid layer and increased evaporation rates. The U.S. Food and Drug Administration (FDA) approved Miebo™ (perfluorohexyloctane ophthalmic solution) on May 18, 2023.

CyclASol^® (cyclosporine ophthalmic solution) is recognized to be potentially the most powerful and comfortable anti-inflammatory DED therapy with high responder rates, rapid onset and unique efficacy on corneal damages combined with high patient satisfaction and comfort. The U.S. Food and Drug Administration (FDA) approved VEVYE™ (cyclosporine ophthalmic solution) on May 30, 2023 as the first cyclosporine-containing therapy for the treatment for the signs and symptoms of dry eye disease (DED). The product is currently in regulatory review for potential approval in Europe and China. The Prescription Drug User Fee Act (PDUFA) target action date set by the FDA for announcing its decision on Novaliq’s NDA after reviewing the application is June 8, 2023.
Today anti-inflammatory therapeutic options are standard for care in DED. Inflammation is the key underlying driver of the disease as chronic immunologic processes have a pivotal role in the pathology of dry eye. The chronic inflammatory nature of DED also causes progressive corneal surface damage. Corneal surface damage can negatively affect visual function and any refractory eye care outcome in particular in cataract or refractive patients where dry eye is common.
Despite several anti-inflammatory therapeutic options approved, there is a large unmet need for a therapy that can rapidly and reliably repair corneal surface damage secondary to DED. Also better comfort is a high unmet need.