Softacort®, preservative‐free hydrocortisone 0.335% drops: A new anti‐inflammatory drop with minimal effects on intraocular pressure

Abstract

PurposeThe aim of this study was to compare the changes in intraocular pressure (IOP) after instillation of a new preservative‐free hydrocortisone 0.335%(Softacort®), prednisolone 1% (Inflanefrane® Forte), loteprednol etabonate 0.5% (Lotemax®) and rimexolone 1% (Vexol®) in comparison with dexamethasone 0.1% (Maxidex®) in a rat model of glucocorticoid‐induced ocular hypertensionMethodsSixty albino female rats were divided into 5 treatment groups and drops administered twice daily from Day 1 to Day 36. Clinical examination, body weight, and IOP measurements were assessed once weekly during 5 weeks.ResultsAnimals treated with Softacort®, Lotemax® or Vexol® had a similar body weight gain. Inflanefran® Forte‐treated animals showed a lower body weight gain. Maxidex®‐treated animals gained weight up to 7 days but there after lost weight as expected. Animals treated with Softacort®, Lotemax®, Inflanefran® Forte or Vexol® had a similar IOP profile with a slow increase in the mean IOP up until Day 15, and then stabilization at +2 mmHg above baseline throughout the remainder of the study Maxidex®‐treated animals showed, as expected, an increase of the mean IOP until Day 36 reaching +4.4 mmHg and progressively increasing.ConclusionsThis study shows significant differences in the IOP rise and therefore greater safety of this new preservative‐free hydrocortisone and other soft corticoids when compared to Maxidex. Twice daily instillation of Softacort® induced a slight IOP elevation which stabilized after 2‐weeks whilst dexamethasone treatment led to a significant continuing IOP increase and drastically reduced body weight gain. Thus, Softacort®, a preservative free hydrocortisone 0.335%, shows a good balance between efficacy and minimal side effects and has just obtained the Marketing Authorization in Europe.