Abstract
Purpose :
Demodex blepharitis is present in the majority of eyecare patients; however, there are no FDA-approved therapeutics for this condition. The purpose of this study was to evaluate the safety (through Day 90) of lotilaner ophthalmic solution, 0.25% applied BID for 43 days for the treatment of Demodex blepharitis in patients 18 years of age or older.
Methods :
Saturn-2 was a randomized, controlled, double-masked study of 412 subjects at 21 US sites. Inclusion required >10 upper lashes with collarettes, mild or worse lid margin erythema, and ≥1.5 mites/lash in at least one eye. Subjects administered 1 drop of lotilaner or vehicle in each eye BID for 43 days. Assessment of treatment-emergent adverse events (TEAEs) was followed through Day 90.
Results :
The treatment-related ocular TEAEs reported at the highest frequencies in the TP-03 group were instillation site pain (7.9%), dry eye (1.5%), chalazion, conjunctival hyperemia, eyelid pruritus, photophobia, instillation site irritation, and vital dye staining cornea (1.0% each). The treatment-related ocular TEAEs reported at the highest frequencies in the vehicle group were instillation site pain (6.7%), visual acuity reduced (1.4%), and visual impairment (1.0% each). The nonocular events reported at the highest frequencies in the TP-03 group were urinary tract infection, nasopharyngitis, SARS-CoV-2 test positive (1.5% each), seasonal allergy, upper respiratory tract infection, and asthma (1.0% each). The only nonocular events reported in more than 1 subject each in the vehicle group were vertigo, urinary tract infection, rib fracture, and dyspnea (1.0%).
Conclusions :
There are yet no FDA-approved topical therapeutic options for treating Demodex blepharitis. This follow-up safety data reports a low rate of treatment-related ocular events, mostly mild in nature, of lotilaner ophthalmic solution, 0.25% for treating Demodex blepharitis.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.