Posters

Prospective randomised phase 2 study evaluating the safety and efficacy of travoprost intraocular implants

Poster Details

First Author: R.Ang PHILIPPINES

Co Author(s):                        

Abstract Details

Purpose:

This US IND phase 2 study evaluates the safety and efficacy of two Travoprost Intraocular Implants, one with a fast-elution rate and one with a slow-elution rate (referred to as iDose-slow and iDose-fast) compared to Timolol Ophthalmic Solution, 0.5%, in subjects with OAG or OHT, either on no ocular hypotensive medication or using up to 3 medications. The iDose is a novel sustained-release travoprost implant (Glaukos, USA).

Setting:

A total of 22 investigative sites (21 in the US and one in the Philippines) enrolled and randomized subjects for this study.

Methods:

This is a prospective, randomized, double-masked, active-controlled, parallel-group, multicenter US IND phase 2 trial. The study enrolled phakic or pseudophakic subjects aged ≥18 years diagnosed with mild to moderate OAG or OHT on 0 to 3 medications, with a baseline mean diurnal IOP of 21-36 mmHg in the study eye (a washout was required for subjects on ocular hypotensive medication(s)). Qualified subjects were randomized (1:1:1) to implantation with iDose-fast or iDose-slow as a standalone procedure, or treatment with topical timolol BID. Key study assessments include: BCVA, pachymetry, VF, endothelial cell density, biomicroscopy, gonioscopy, ophthalmoscopy (including C/D ratio), and AEs.

Results:

A total of 154 subjects were randomized to the study: iDose-slow (n=54), iDose-fast (n=51), timolol (n=49). All subjects have completed the 12-week follow-up visit with continued ongoing follow-up through 3 years. Initial efficacy was demonstrated through Week 12 with all 3 study groups achieving at least 30% IOP reduction. An excellent safety profile was observed with no reports of hyperemia, intraoperative or serious ocular AEs to date in the iDose groups. Subjects continue to be followed-up per study design. Longer term outcomes will be reported at the time of presentation.

Conclusions:

Travoprost Intraocular Implants (iDose) showed favorable efficacy and safety in this study. The iDose implant has the potential to change the treatment paradigm in glaucoma.

Financial Disclosure:

research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented