Abstract
Purpose :
Many patients with dry eye disease (DED) suffer from episodic flare-ups that require an effective short-term treatment. OTX-DED is a physician-administered, biodegradable, preservative-free, hydrogel-based insert that is placed into the canaliculus and releases dexamethasone to the ocular surface for 2-3 weeks. In this study, we evaluated the efficacy and safety of OTX-DED in subjects with dry eye disease.
Methods :
Prospective, randomized, double-masked, vehicle-controlled Phase 2 study at 15 US sites. Adult subjects diagnosed with DED in both eyes for >6 months, eye dryness severity score ≥30 and bulbar conjunctival hyperemia grade ≥2 were randomized 1:1:1 to receive either OTX-DED 0.2 mg, OTX-DED 0.3 mg or hydrogel-vehicle (HV) insert. Subjects (N=166) received the same treatment bilaterally on Day 0 and were followed for 8 weeks. The primary endpoint was photographic assessment of bulbar conjunctival hyperemia in the worst zone on Day 15 evaluated by a central reading center and graded using the Cornea and Contact Lens Research Unit grading scale (0 to 4 scale for each zone [nasal, temporal, frontal]). Adverse events (AEs) were collected.
Results :
Both 0.2 mg and 0.3 mg groups met the primary endpoint of a statistically significant difference in conjunctival hyperemia in the worst zone compared to HV on Day 15 (P=0.004 and P=0.028, respectively). Change from baseline in mean conjunctival hyperemia grade in the 0.2 mg, 0.3 mg and HV group was -0.51, -0.43, and -0.21 respectively. Statistically significant differences in conjunctival hyperemia compared to HV were also observed for total, nasal, temporal and frontal zones in the 0.2 mg group and total, nasal, and temporal zones in the 0.3 mg group (all P<0.05). No serious ocular AEs were reported. The most common ocular AEs reported by subjects treated with OTX-DED (both 0.2 and 0.3 mg pooled; n=111) were increased lacrimation (8.1%), and intraocular pressure elevation (3.6%).
Conclusions :
OTX-DED 0.2 mg and 0.3 mg dexamethasone intracanalicular insert significantly improved bulbar conjunctival hyperemia compared to hydrogel-vehicle in subjects with dry eye disease. Both insert doses were generally safe and well-tolerated.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.