The European Medicines Agency (EMA) has accepted Santen Pharmaceutical’s (Santen) marketing authorisation application (MAA) for use of STN1013001 (cationic emulsion of latanoprost 50μg/ml) for lowering of intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension, the company announced.
Ocular surface disease (OSD) represents an emerging problem in the management of glaucoma, the company outlined, with up to 60% of glaucoma patients having dry eye.
OSD is a multifactorial ocular condition that may involve tear film degradation in addition to damage to the ocular surface, negatively impacting quality of life and compromising adherence to glaucoma eye drop treatment, which can influence the efficacy of the therapy.
STN1013001 is preservative-free latanoprost 50μg/ml presented in a lipid-containing cationic emulsion, the technology of which means the positively-charged emulsion droplets are attracted onto the negatively-charged ocular surface to increase its spreading and residence time on the ocular surface.
The application is based on a clinical package including positive results from a phase 3 trial of cationic emulsion of latanoprost 50μg/ml versus latanoprost 50μg/ml. The trial established the IOP lowering efficacy of STN1013001 by demonstrating its non-inferiority to latanoprost 50μg/ml at both 9am and 4pm time points at week 12. Additionally, both time points at week four achieved the same criteria of non-inferiority as week 12.
A key secondary endpoint was also met of the superiority of STN1013001 in improving OSD versus latanoprost, with a significant improvement in corneal fluorescein staining (CFS) score at week 12, the company reported.
“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 Christophe Baudouin, professor and chairman of ophthalmology at Quinze-Vingts National Ophthalmology Hospital, Paris, and principal investigator of the phase 3 study.
The patented cationic emulsion technology, developed by Santen, is used as the ‘core technology’ for other marketed products in more than 30 countries, including in artificial tears for dry eye disease, Santen outlined in a statement.
“This innovation is something Santen is very proud of since the cationic emulsion technology was developed by our R&D team here in the EMEA region,” said Luis Iglesias, president and head of Santen EMEA and North America. “We are hopeful of bringing this innovative product to patients as a treatment for glaucoma while also tackling unmet needs in OSD.”