Abstract
Purpose :
Topical prostaglandin analogues are first line therapy for the treatment of open-angle glaucoma (OAG). Although effective if dosed properly, patient adherence with eyedrops is poor and worsens in proportion to increased medication (med) burden in terms of both number of bottles and frequency of dosing. Additional drawbacks include ocular surface disease and cosmetic side effects. To address these drawbacks, two travoprost-eluting intraocular implants (iDose) were developed. We conducted a Phase 2, randomized, double-masked, multicenter trial to compare the safety and efficacy of these implants to timolol 0.5% BID in reducing IOP in OAG or ocular hypertension. This submission provides analysis of the subset of patients on the same or lesser topical IOP-lowering therapy at 36 months vs screening.
Methods :
Randomized patients on 0 to 3 medications at screening received iDose-FE (fast eluting; n=51), iDose-SE (slow eluting; n=54) or underwent sham procedures and received timolol BID (n=49). iDose patients received placebo eyedrops. Additional topical IOP-lowering meds were added per protocol for patients with IOP >18mmHg at any visit. In this analysis, the proportion of patients on the same or lesser number of topical IOP-lowering meds at month 36 vs screening were evaluated. Mean change from 8AM baseline IOP was evaluated at month 36 in this population. Adverse events and safety parameters were evaluated.
Results :
iDose-FE and iDose-SE demonstrated a clinically relevant IOP-lowering effect of 8.3 and 8.5mmHg, respectively, vs 8.2mmHg for timolol control. 70% of iDose-FE and 68% of iDose-SE subjects were well controlled on iDose with the same or lesser topical med burden at 36 months vs screening, vs 46% of subjects on timolol. iDose was generally well tolerated with no adverse events of conjunctival hyperemia, periorbital fat atrophy, clinically significant endothelial cell loss, and only a single adverse event of iris color change.
Conclusions :
Robust, sustained IOP-lowering was achieved with both iDose models. The therapy was generally well tolerated over a period of 36 months. A responder analysis demonstrates substantial reduction in topical med burden for iDose-treated eyes, thus making iDose an attractive alternative to topical IOP-lowering therapy. iDose is currently being evaluated in two Phase 3 pivotal trials with results expected in late 2022.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.