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Abstract
Purpose
To assess the effectiveness and safety of bimatoprost sustained release (SR) glaucoma implant as a treatment for open-angle glaucoma and ocular hypertension in a real-world private practice setting with a significant American Indian population.
Methods
This retrospective study included 156 eyes from adult patients who received a single injection of bimatoprost implant between June 2020 and May 2022 at the Oklahoma Eye Surgeons. Patients were stratified by baseline intraocular pressure (IOP) (≥21 mmHg versus IOP<21 mmHg). The co-primary endpoints were changes in the mean IOP and the number of topical IOP-lowering medications from baseline to Month 6.
Results
At 6 months, eyes with baseline IOP≥21 mmHg had a significantly lower mean IOP (19.85±8.01 versus 26.25±4.84 mmHg; p<0.0001) and the mean number of IOP-lowering medications (1.04±1.44 versus 1.38±1.50; p=0.048) compared with baseline. One year after implantation, 73.58% of eyes had a ≥20% reduction in IOP, 41.51% were medication-free and 30.19% were receiving at least one fewer medication. Among eyes with baseline IOP<21 mmHg, there was a significant reduction in the mean number of IOP-lowering medicines by Month 6 (0.61±1.03 versus 1.93±1.21 at baseline; p<0.0001), with no change in IOP. At 12 months, 24.27% of eyes had a ≥20% decrease in IOP, 43.69% of eyes did not require any medications and 63.11% had at least one fewer medication compared with baseline. An analysis using Welch’s two-sample t–test showed no significant differences in the outcomes between the overall population and the American Indian population (number of eyes, 23).
Conclusion
Bimatoprost SR glaucoma implant lowered IOP in eyes with high, uncontrolled baseline IOP, while it reduced the number of medications in eyes with a controlled baseline IOP. No clinically meaningful and statistically significant differences in the efficacy of bimatoprost were observed in patients of American Indian descent.
Abbreviations
ADAGES, African Descent and Glaucoma Evaluation Study Groups; AI, American Indian; CI, confidence interval; EDC, electronic data capture; IOP, intraocular pressure; LALES, Los Angeles Latino Eye Study; PACG, primary angle-closure glaucoma; POAG, primary open-angle glaucoma; SD, standard deviation; SR, sustained release.
Acknowledgments
Data entry support was provided by Alyssa Beadle, BS, COA, OSC and Hannah Reynolds, BS, OSC. Medical writing support was provided by Scientific Writers Ltd., UK for manuscript preparation.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
Steven R. Sarkisian Jr., MD is a consultant on the speakers’ bureau for Allergan/AbbVie and reports grants, personal fees from Allergan, during the conduct of the study; grants, personal fees from Alcon, personal fees from Aerie, grants from AbbVie, grants from Allysta, personal fees from Bausch & Lomb, personal fees from BVI, personal fees from Carl Zeiss, grants from Elios, grants, personal fees from Glaukos, grants, personal fees from IStar, personal fees from Katena, personal fees from MST, personal fees from Novartis, grants from Ocular Science, grants, personal fees from Ocular Therapeutix, personal fees from Santen, grants, personal fees from Sight Sciences, personal fees from TearLab Corp, outside the submitted work. The authors report no other conflicts of interest in this work.