Travoprost implant shows ‘robust’ IOP reduction at 3 months
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Key takeaways:
- The phase 3 trial investigated a fast-eluting and a slow-eluting travoprost implant.
- Both models demonstrated statistical and clinical noninferiority compared with timolol.
The travoprost intraocular implant demonstrated a reduction in IOP in patients with open-angle glaucoma or ocular hypertension 3 months after a single administration, according to a study published in Ophthalmology.
“The iDose is safe and effective in phakic patients with no incidence of cataract or endothelial cell loss developing during the study follow-up,” Steven R. Sarkisian Jr., MD, lead author of the study, told Healio.
In the phase 3 multicenter, randomized, double-masked, sham-controlled, noninferiority trial, participants received a fast-eluting travoprost implant (200 eyes) or a slow-eluting travoprost implant (197 eyes) plus placebo eye drops administered twice daily or a sham procedure (193 eyes) plus timolol ophthalmic solution 0.5% administered twice daily.
The primary outcome was mean change from baseline IOP in the study eye at 8 a.m. and 10 a.m. at day 10, week 6 and month 3, and safety outcomes included assessment of adverse events, corneal endothelial cell counts, visual acuity and conjunctival hyperemia.
There was a mean reduction in IOP ranging from 6.6 mm Hg to 8.4 mm Hg from baseline in the fast-eluting implant group, from 6.6 mm Hg to 8.5 mm Hg in the slow-eluting implant group and from 6.5 mm Hg to 7.7 mm Hg in the timolol group over the six time points. The study met its primary endpoint, and both implant groups demonstrated statistical and clinical noninferiority compared with timolol regarding IOP-lowering efficacy.
The most commonly reported adverse events included iritis, ocular hyperemia, reduced visual acuity and increased IOP, most of which were of mild or moderate severity. There was one case of endophthalmitis in a study eye.
“The travoprost intraocular implant demonstrates robust IOP reduction that was noninferior to timolol over a 3-month primary efficacy evaluation period and provides a safe and effective alternative to topical IOP-lowering medication,” the authors wrote.
Investigator commentary from Steven R. Sarkisian Jr., MD
We already know that 90% of patients on glaucoma medications are noncompliant to varying degrees. I think many ophthalmologists live as though their patients were somehow special and the data do not apply to them.
The simple facts about noncompliance with topical medications should make us stop and reconsider the conventional treatment algorithm in which eye drops are first line for elevated IOP management. I would suggest primary selective laser trabeculoplasty followed by iDose if the patient is not at target IOP following SLT or if SLT fails in less than 6 to 12 months. Medications can now be third line after SLT and iDose, and we should be able to reach full compliance in 80% or more of patients.
Remember, most glaucoma patients can be controlled after SLT and one or two medications without the need for a “glaucoma specialist.”
For more information:
Steven R. Sarkisian Jr., MD, of Oklahoma Eye Surgeons, can be reached at drsarkisian@okeyesurgeons.com.
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