Alcon presented new data from the COMPASS Randomized Controlled Trial that reinforce the clinical value of its CyPass Micro-Stent, a microinvasive glaucoma surgery (MIGS) device implanted at the time of cataract surgery in patients with mild-to-moderate primary open-angle glaucoma. The data were presented today at the 2018 American Glaucoma Society (AGS) annual meeting, taking place March 1-4, 2018 in New York City.
“We are encouraged by this new data because it has potential real-world implications for patients and physicians struggling to manage glaucoma and who might be looking for better surgical options,” Jaime Dickerson, Senior Global Brand Medical Affairs Lead, Alcon, said in a company news release. “The CyPass Micro-Stent is not only an important contribution to the MIGS space, but it may also help to slow the progression of glaucoma and stabilize intraocular pressure throughout the day, while helping to relieve patients of the burden of adhering to daily topical medications.”
The COMPASS clinical trial for the CyPass Micro-Stent was the first MIGS study with a 2-year follow-up for more than 500 patients with mild-to-moderate primary open-angle glaucoma (POAG) undergoing cataract surgery. In a post-hoc analysis, the incidence of markers associated with disease progression was compared between the CyPass Micro-Stent group and the control group (cataract surgery only). There was a lower incidence in events associated with glaucoma disease progression, including adverse events for visual field deterioration, optic disc hemorrhage, IOP spikes, and the need for additional glaucoma surgery, in patients implanted with the CyPass Micro-Stent at the time of cataract surgery than in the control group. The difference in the occurrence of IOP spikes was statistically significant (P < .001).
The analysis also shows that a lower proportion of patients in the COMPASS trial who were implanted with the CyPass Micro-Stent at the time of cataract surgery required IOP-lowering medications at 24 months post-implantation (15.2 percent) than those who had cataract surgery alone (40.9 percent).
In a different study fitting the COMPASS data to a circadian IOP model, the results suggest that implantation of the CyPass Micro-Stent resulted in lower mean daily IOP compared to the control group (16.6 mmHg vs. 17.7 mmHg) and a smaller amplitude of IOP fluctuations throughout the day (0.36 mmHg vs. 0.69 mmHg).
These findings will be presented during a scientific poster session at AGS on Thursday, March 1, 7 – 8 a.m. in the Astor Ballroom, New York Marriott Marquis:
- Supraciliary Micro-Stent is Associated with Lack of Disease Progression and Minimum Usage of IOP Lowering Medications in Patients with POAG 2-Years Post-Implantation, Presented by Dr. Brian Flowers
- Evaluation of IOP and a 24-Hour Circadian Rhythm Model after Implantation with a Supraciliary Micro-Stent, Presented by Dr. Brian A. Francis
The CyPass Micro-Stent is implanted just below the surface of the eye, and is uniquely designed to reduce IOP in patients with mild-to-moderate primary open-angle glaucoma. It is the first FDA-approved MIGS device to leverage an entirely new outflow pathway for excess aqueous fluid in the eye. Once implanted, it creates a permanent conduit between the anterior chamber of the eye and the suprachoroidal space to improve the eye's natural drainage pathway.