The Hungarian regulatory authority has agreed to extend the label of Wize Pharma‘s LO2A eye drops to include the treatment of dry eye symptoms in Sjögren’s syndrome patients, the company announced. The treatment is marketed in Hungary as Conheal, by Resdevco.
While the formulation is registered and marketed for the treatment of dry eye syndrome in Hungary, Germany, Switzerland, Israel, and the Netherlands, Hungary and the Netherlands are the only countries to extend the treatment’s approval for dry eye symptoms as a result of Sjögren’s syndrome.
“There are limited therapeutic options for the treatment of the eye problems resulting from Sjögren’s syndrome, all of them used off-label and without specific regulatory authorization,” Noam Danenberg, Wize’s chairman, said in a press release. “Consequently, this approval is an important event in the development plan for LO2A, being the first eyedrops specifically approved for treatment of the ophthalmological symptoms of Sjögren’s syndrome.”
Sjögren’s syndrome patients have reduced tear production, the result of a malfunctioning immune system that targets the glands producing tears and saliva. They experience a persistently dry, scratchy feeling in the eyes that can lead to damage and a decrease in quality of life.
LO2A eye drops are artificial tears commercialized in unit-dose vials that contain isotonic glycerol and hyaluronic acid. The formulation significantly improved dry eye symptoms in Sjögren’s syndrome patients included in a small Phase 2 trial (ISRCTN17717813) in Hungary.
The trial enrolled 21 adult Sjögren’s patients, who received the artificial tears four times a day for three months. The therapy’s efficacy was assessed by ophthalmologic tests and eye symptoms were assessed through the Ocular Surface Disease Index (OSDI) questionnaire.
After three months, both ophthalmologic tests and OSDI scores showed significant improvements in dry eye disease. Moreover, researchers noted that these clinical benefits were detected without the need for anti-inflammatory agents.
Wize Pharma, an Israel-based company, has certain rights to purchase, market, sell, and distribute LO2A in some countries. The company is seeking clinical approval of LO2A for the treatment of dry eye disease in Sjögren’s patients in Israel, the U.S., China, and Ukraine.
“Wize Pharma’s clinical program focuses on pursuing LO2A approval for treatment of ophthalmological symptoms of Sjögren’s syndrome and treatment of conjunctivochalasis in the United States. The European regulatory approvals will provide further supportive data for clinical and regulatory development in the USA,” Danenberg said.