Glaukos announced that a single-site international study of glaucoma subjects recently published in Ophthalmology and Therapy showed that the iStent inject Trabecular Micro-Bypass System, combined with cataract surgery, achieved a 37% reduction in mean IOP to 14.3 mmHg after 3 years of follow-up.
The prospective, non-randomized, consecutive case series was conducted by Fritz H. Hengerer, MD, at the University of Heidelberg in Heidelberg, Germany and included 81 eyes of 55 glaucoma subjects undergoing cataract surgery. The cohort’s preoperative mean medicated IOP was 22.6 mmHg and the preoperative mean number of topical ocular hypotensive medications was 2.5. Approximately 32% of eyes had undergone prior glaucoma surgery and 56% of eyes were on at least three medications prior to iStent inject implantation.
Additional study findings for subjects followed through 3 years (n=41 eyes) included:
- Mean medication burden decreased 68% to 0.8.
- 93% of eyes experienced reduced medications; 54% of eyes were medication free vs. 1% preoperatively.
- All eyes achieved IOP at or below 18 mmHg and 71% achieved IOP at or below 15 mmHg.
- IOP was reduced by 20% or greater in 78% of eyes.
- The safety profile was favorable with no intraoperative complications or significant side effects reported.
“These study results are particularly noteworthy because they were achieved across a clinically diverse patient population that reflects a real-world practice,” Dr. Hengerer, who performed all of the procedures and authored the study, said in a company news release. “The results show that iStent inject in combination with cataract surgery is a procedure capable of delivering substantial reductions in IOP and medication burden not only in mild to moderate glaucoma cases, but also in subjects who were previously using multiple topical medications or had undergone prior glaucoma surgeries.”
The full published article is available here. Certain data from this study were presented previously at ophthalmic conferences in the United States and Europe.
“This study underscores the potential for iStent inject to be a viable alternative to glaucoma patients’ chronic use of topical medications, which often require complex dosing regimens, have multiple side effects and can be ineffective due to high rates of non-adherence,” said Thomas Burns, Glaukos president and chief executive officer. “Our fundamental goal is to transform glaucoma therapy by providing ophthalmic surgeons and their patients a comprehensive set of MIGS technologies designed to safely and effectively manage IOP across the full range of glaucoma progression and severity.”