Catioprost (latanoprost emulsion) / Santen - LARVOL DELTA

A Phase III Multinational Multicenter Investigator-Masked Randomized Active-Controlled Trial Comparing the Efficacy and Safety of DE-130A With Xalatan® in Patients With Open-Angle Glaucoma or Ocular Hypertension (clinicaltrials.gov) - P3 | N=386 | Completed | Sponsor: Santen SAS | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Glaucoma • Ophthalmology

New trends towards glaucoma treatment: Topical osmoprotective microemulsions loaded with latanoprost. (PubMed, Ocul Surf) - "Relative ocular bioavailability was 4.5 and 19 times higher than the marketed formulation. These findings suggest the use of these microemulsions as potential combined strategies for extended surface protection and glaucoma treatment."

Journal • Glaucoma • Ophthalmology

A Phase III Multinational Multicenter Investigator-Masked Randomised Active-Controlled Trial Comparing the Efficacy and Safety of DE-130A With Xalatan® in Patients With Open-Angle Glaucoma or Ocular Hypertension (clinicaltrials.gov) - P3 | N=386 | Active, not recruiting | Sponsor: Santen SAS | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2021 ➔ Oct 2022 | Trial primary completion date: Dec 2020 ➔ Feb 2022

Enrollment closed • Trial completion date • Trial primary completion date • Glaucoma • Ophthalmology

A novel ophthalmic latanoprost 0.005% nanoemulsion: a cytotoxicity study. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "The new latanoprost nanoemulsion is significantly less cytotoxic on human conjunctival cells than LSc. These results suggest that the new formulation might be gentler on the eye surface than currently available BAK-preserved latanoprost solutions."

Journal • Glaucoma • Ophthalmology

Interactions in vitro and in vivo of Catioprost with human meibum and Tear Films (ARVO 2020) - "Thus the interaction of Catioprost (CPT), an unpreserved Latanoprost 0.005% cationic nanoemulsion, with meibomian and tear films in vitro and in vivo deserves special study. Similar effects on TFLL and TF were observed in vivo at the ocular surface. In vitro and in vivo data complement each other and facilitated the study of the composition-structure-function relationship that determines the impact of cationic nanoemulsions on TF."

Preclinical

A Phase III Multinational Multicenter Investigator-Masked Randomised Active-Controlled Trial Comparing the Efficacy and Safety of DE-130A With Xalatan® in Patients With Open-Angle Glaucoma or Ocular Hypertension (clinicaltrials.gov) - P3; N=380; Recruiting; Sponsor: Santen SAS

Clinical • New P3 trial

The Gomez-Ulla Institute participates in an international glaucoma trial (El Correo Gallego) - "The Gómez-Ulla Ophthalmological Institute will participate in an international clinical trial to evaluate the efficacy and safety of a new drug for open-angle glaucoma or ocular hypertension. The clinic has just been selected to participate in this research focused on the drug DE-130A."

New trial

Edited transcript of 4536.T earnings conference call or presentation 1-Aug-19 7:00am GMT (Yahoo Finance) - "DE-130A. This is Catioprost, a new formulation of a prostaglandin analog for the European and Asian market. And we hope to complete Phase III in 2021."

Trial status