Abstract
Purpose :
Though topical ophthalmic steroids are effective in treating allergic conjunctivitis (AC), physicians report infrequent use due to side effects and/or risk of abuse associated with long term use demonstrating the need for a physician administered sustained release steroid with a favorable safety profile. DEXTENZA (dexamethasone ophthalmic insert) 0.4mg is a hydrogel-based intracanalicular insert designed to deliver preservative-free dexamethasone over 30 days. The objective of this study is to evaluate the safety of a steroid insert (DEX) for the treatment of signs and symptoms of chronic AC.
Methods :
This was a pooled post-hoc analysis of four prospective, randomized, double-masked, vehicle-controlled, parallel-group studies using a modified Conjunctival Allergen Challenge (CAC) model. In all studies, subjects with a history of ocular allergies were randomized to receive DEX or placebo (PV) inserted into the canaliculus of both eyes on the same day. Safety assessments were performed in each of the four studies which included assessments of adverse events (AEs), visual acuity (VA), and intraocular pressure (IOP).
Results :
The safety population from the four trials included 315 subjects (DEX N=154, PV N=161). Overall, 12.3% and 14.3% of DEX and PV subjects reported ocular adverse events, respectively, all of which were mild or moderate in severity. No ocular SAEs were reported and there was a single non-ocular SAE across the four trials (hospitalization due to depression in the DEX group) which was considered unrelated to study treatment. The most common adverse events (>1%) in DEX-treated subjects were increased IOP (3.2%), reduced VA (1.3%), lacrimation increased (1.3%), and eye discharge (1.3%). All AEs of increased IOP were resolved. VA assessments showed no consistent changes over time and all instances of worsening VA were transient. There were no patterns of AEs that would raise concern regarding the safety of DEX.
Conclusions :
Overall, findings from the pooled post hoc analysis of four studies demonstrated DEX was generally safe and well tolerated for the treatment of allergic conjunctivitis. Rates of increased IOP following treatment with DEX were low. The physician-administered insert has the potential to be a non-abusable, hands-free, alternative to steroid eye drops.
This is a 2021 ARVO Annual Meeting abstract.