■ Santen Pharmaceutical Co., Ltd., announced that the European Medicines Agency has accepted its application for the use of STN1013001 for lowering IOP in open-angle glaucoma and ocular hypertension. The preservative-free latanoprost 50 μg/mL is formulated in a lipid-containing cationic emulsion. According to the company, the technology causes positively charged emulsion droplets to be attracted to the negatively charged ocular surface to increase spreading and residence time on the ocular surface. The company said in a news release that it improves the tear film lipid layer and is used in marketed products — including artificial tears — in more than 30 countries.

The application is based on positive results from a phase 3 noninferiority trial conducted in Europe and Asia (STN1013001 vs latanoprost 50 μg/mL). The secondary endpoint of STN1013001 in improving ocular surface disease was demonstrated vs latanoprost with a significant improvement in corneal fluorescein staining score at week 12.

“This combination of effective IOP lowering alongside the potential to protect and improve the ocular surface is a development that we hope can help many patients who find eye drop treatments challenging — adherence can be poor, quality of life impacted and rates of failure of glaucoma surgery greater than we would wish,” said principal investigator Christophe Baudouin, MD, PhD, professor and chairman of ophthalmology at Quinze-Vingts National Ophthalmology Hospital, Paris.