Glaukos (NYSE:GKOS) said today data from a 3-year study of its iStent Trabecular micro-bypass stent indicated that it, along with cataract surgery, lowered mean intraocular pressure 36% and reduced mean glaucoma medications by 86% 3 years post-surgery.
The study reported a mean IP of 14.99 mmHg in 39 patients monitored after treatment for 3 years, compared to a mean preoperative IOP of 23.4 mmHG. The mean number of glaucoma medications used after 3 years dropped to 0.3, compared with a preoperative mean of 1.9 medications.
No operative complications were reported, but 5 secondary surgeries, 2 postoperative ocular ocular sequelae and 2 non-ocular adverse events were reported, Laguna Hills, Calif.-based Glaukos said.
“These data show that implantation of a single iStent in conjunction with micro-incisional cataract surgery provided a sustained reduction in IOP and medication burden with favorable safety through three years postoperative for this patient population with moderate and varied types of glaucoma. In the study, the decision to implant the iStent was based on the wish of the patient to reduce or possibly eliminate the burden of topical glaucoma medications and the intention to offer a surgical treatment for glaucoma with a favorable safety profile. We did not qualify subjects based on specific inclusion or exclusion criteria. Consequently, the population studied in this series was representative of a European clinician’s real-world experience with a typical patient group,” study investigator Dr. Tobias Neuhann of Munich’s Eye Clinic Marienplatz said in a prepared statement.
The prospective, open-label, non-randomized study aimed to assess long-term postoperative outcomes from single iStent implants used during cataract surgery in patients with primary open-angle glaucoma, psuedoexfoliation glaucoma, secondary or post-traumatic glaucoma or ocular hypertension, the company said.
Earlier this month, Glaukos said it won a nod from the FDA for an investigational new drug Phase II study of its Travoprost intraocular implant utilizing the company’s iDose delivery system for patients with glaucoma.
The iDose system is injected through a clear corneal incision and secured in the anterior chamber to continuously elute therapeutic levels of Travoprost medication within the eye over extended periods of time, Glaukos said.
The product and procedure is an alternative to chronic daily prescription eye drop treatments, which can be subject to high rates of non-compliance, Glaukos said. Travoprost is a prostaglandid analog that is used to reduce intraocular pressure.