Santen Filing Accepted by EMA for Review of Application for STN1013001 Cationic Emulsion of Latanoprost 50μg/mL in Glaucoma

Santen Pharmaceutical announced European Medicines Agency (EMA) acceptance for review of a marketing authorization application for the use of STN1013001 for lowering of IOP in open-angle glaucoma and ocular hypertension.

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.[5] This patented cationic emulsion technology, developed by Santen, improves the tear film lipid layer surface properties[6] and used as the core technology for other marketed products in more than 30 countries, including in artificial tears for dry eye disease.

Latanoprost reduces elevated IOP[7] and is Europe’s most prescribed prostaglandin analogue.[8]

The marketing authorization application is based on a clinical package including positive results from a phase 3 clinical trial conducted in Europe and Asia—a noninferiority trial of cationic emulsion of latanoprost 50μg/mL versus latanoprost 50μg/mL. The IOP lowering efficacy of STN1013001 was established by demonstrating its noninferiority to latanoprost 50μg/mL at both 9 am and 4 pm time points at week 12. In addition, both time points at week 4 also achieved the same criteria of noninferiority as week 12. The superiority of STN1013001 in improving OSD (secondary endpoint) was demonstrated versus latanoprost with a significant improvement in corneal fluorescein staining (CFS) score at week 12.[9]

“Despite the progress in the understanding of glaucoma and the many possible treatment options, there is an increasing appetite for innovation as we still see the disease progressing and causing much vision loss across the world. 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,” Professor Christophe Baudouin, MD, PhD, Professor and Chairman of Ophthalmology at Quinze-Vingts National Ophthalmology Hospital, Paris, and principal investigator of the phase 3 study, said in a news release.

References

1. Erb et al. German register for glaucoma patients with dry eye. Basic outcome with respect to dry eye. Graefes Arch Clin Exp Ophthalmol 2008 Nov; 246(11):1593-601

2. Garcia-Feijoo and Sampaolesi. A multicenter evaluation of ocular surface disease prevalence in patients with glaucoma; Clinical Ophthalmology 2012:6 441–446

3. Rossi et al. Eur J Ophthalmol 2009; 9:572-9

4. Zhang et al. Eye Contact Lens 2019; 45(1):11–18

5. Lallemand F et al. Successfully improving ocular drug delivery using the cationic nanoemulsion, Novasorb. J

   Drug Deliv. 2012; 2012:604204. DOI: 10.1155/2012/604204. Epub 2012 Feb 27

6. Georgiev GA et al. Surface chemistry interactions of Cationorm with films by human meibum and tear film

   compounds. Int J Mol Sci 2017 Jul 18; 18(7):1558. DOI: 10.3390/ijms18071558

7. Latanoprost SmPC https://www.medicines.org.uk/emc/product/2983/smpc#gref. Last accessed Sept 2022