Abstract
Purpose :
Ocular surface inflammation plays a key role in all types of dry eye disease (DED) and corticosteroids are well-established as a fast-acting and effective treatment for signs and symptoms of DED. OTX-DED is an intracanalicular insert containing 0.2 mg of dexamethasone entrapped in a hydrogel matrix designed to provide sustained-release dexamethasone to the ocular surface. OTX-DED is similar to DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg (indicated to treat post-ophthalmic surgery inflammation and pain) but contains lower doses of dexamethasone and a shorter intended duration of therapy. The objective of the study was to characterize the pharmacokinetics of the 0.2 mg dose of OTX-DED in a beagle model.
Methods :
OTX-DED inserts containing 0.2 mg dexamethasone were placed into the canaliculus of beagle dogs. Beagle dogs were selected as the animal model since the morphometry of the nasolacrimal system provides an appropriate sized puncta and canaliculus. Tear fluid samples were collected using 10 mm Schirmer test strips from beagle dog eyes throughout the study duration after insertion of OTX-DED into the canaliculus and concentrations of dexamethasone in tear fluid were measured using liquid chromatography with tandem mass spectrometry.
Results :
The average dexamethasone concentration in the beagle tear fluid of the 0.2 mg dexamethasone insert is presented in Figure 1. Results demonstrated sustained drug release into the tear fluid with concentrations declining over the study duration as the dexamethasone became depleted from the insert. This decrease in tear fluid concentration is evidenced in the 0.2 mg dose after 14 days. The profile demonstrates sustained levels of dexamethasone in the tear fluid through 7 days followed by a tapering from day 7 to 14 days with a complete release of dexamethasone from the insert by 17 days.
Conclusions :
OTX-DED at a dose of 0.2 mg delivered dexamethasone to the ocular surface for approximately 14 days. Comparatively, DEXTENZA (0.4 mg) delivered dexamethasone to the ocular surface up to 28 days. In vivo dexamethasone release data indicates a shorter duration of drug release for the 0.2 mg dose compared to the 0.4 mg from the hydrogel insert in the beagle model.
This is a 2021 ARVO Annual Meeting abstract.