Official ESCRS | European Society of Cataract & Refractive Surgeons
Vienna 2018 Delegate Registration Programme Exhibition Virtual Exhibition Satellites 2018 Survey


escrs app advert


Search Title by author or title

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


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).


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


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.


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.


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

Back to Poster listing