Bimatoprost implant improves long term results in glaucoma treatment
USA: The bimatoprost implant has the potential to improve adherence and reduce the treatment burden in glaucoma, according to a recent study published in the journal Ophthalmology. Results from the phase III study revealed that both 10-µg and 15-µg implants are efficient in maintaining lowered intraocular pressure (IOP) for up to 12 months after the final implant placement.
Open-angle glaucoma (OAG) is a vision-threatening, chronic, irreversible disease that requires IOP lowering treatment for slowing or preventing the disease progression. As the disease advances, the economic costs of glaucoma increases and quality of life decreases due to which early management and adherence to treatment are important.
Felipe A. Medeiros, Department of Ophthalmology, Duke University, Durham, North Carolina, and colleagues conducted the study to evaluate the IOP lowering efficacy and safety of 10- and 15-μg bimatoprost implant in subjects with OAG and ocular hypertension (OHT) after initial and repeated administrations.
The randomized phase 3 clinical trial included adults with OAG or OHT in each eye, open iridocorneal angle inferiorly in the study eye by clinical gonioscopy, and study eye baseline IOP (H0; 8 am±1 h) of 22–32 mmHg after washout. Study eyes received bimatoprost implant 10 μg (n=198) or 15 μg (n=198) on Day 1 with readministration at Weeks 16 and 32, or twice-daily topical timolol maleate 0.5% (n=198). IOP was measured at Hours 0 and 2 at each visit.
Primary endpoints were IOP and change from baseline IOP through Week 12.
Key findings of the study include:
- Over the study period, the proportion of TAVR performed using CS increased from 33% to 64%, and CS was used in a median of 0% and 91% of cases in the lowest and highest quartiles of hospital CS use, respectively.
- On the basis of instrumental variable analysis, CS was associated with decreases in in-hospital mortality (adjusted risk difference: 0.2%) and 30-day mortality (adjusted risk difference: 0.5%), shorter length of hospital stay (adjusted difference: 0.8 days), and more frequent discharge to home (adjusted risk difference: 2.8%) compared with GA.
- The magnitude of benefit for most endpoints was less than in a traditional propensity score–based approach.
"Ongoing studies are evaluating other administration regimens to reduce the potential for CECD loss. The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma," concluded the authors.
The study, "Phase 3, Randomized, 20-Month Study of Bimatoprost Implant in Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 1)," is published in the journal Ophthalmology.