Alcon has officially launched its new CyPass Micro-Stent, a minimally invasive glaucoma surgical (MIGS) device, in Australia. The device is specifically indicated for the treatment of patients with mild to moderate primary open-angle glaucoma who are undergoing cataract surgery, even if they have not failed medical treatments for their glaucoma. It is approved for use by the Therapeutics Goods Administration as a standalone procedure for open-angle glaucoma where medical treatments have failed.
The CyPass Micro-Stent is implanted just below the surface of the eye and uses one of the eye’s natural drainage pathways. The first MIGS device to be approved for insertion into the supraciliary space – the area between the sclera and the ciliary body – the CyPass Micro-Stent creates a permanent conduit to allow aqueous to drain out via the uveoscleral pathway, the same route used by first line prostaglandin analogue medications.
The device is designed to reduce the need for, and burden of, topical glaucoma medication administration. For many patients with glaucoma, adherence with medication can be challenging due to side effects, difficulty administering drops, and the need for daily eye drop use. As approximately 15–20 per cent of patients undergoing cataract surgery have glaucoma, combining the CyPass Micro-Stent procedure with cataract surgery allows two problems to be addressed at one time. Inserted via an ab interno approach, the procedure causes minimal tissue disruption and leaves the conjunctiva undisturbed, meaning future filtration surgery (if needed) remains an option.
As part of the launch, Alcon hosted a number of roadshow events in Sydney, Melbourne, Brisbane, Perth, and Adelaide with international and local guest speakers. Dr. Leon Au from the Manchester Royal Eye Hospital in the UK presented a keynote reviewing advances in MIGS devices, his personal experience with the CyPass Micro-Stent, clinical trials results, and surgical pearls. In his review of the advances in glaucoma surgery, Dr. Au concluded there is a strong patient desire for procedures that are safe, which reduce the need for medications, and that require minimal or no time off work. In his practice, he uses the CyPass Micro-Stent in conjunction with cataract surgery to treat patients with mild to moderate open-angle glaucoma to lower IOP and reduce the need for glaucoma medications.
The first MIGS device to be approved for insertion into the supraciliary space
Dr. Au reported COMPASS trial results, a pivotal trial comparing cataract surgery with the CyPass Micro-Stent to cataract surgery alone. This study enrolled 505 eyes with mild to moderate open-angle glaucoma and randomised them in a 3:1 ratio to phacoemulsification with the CyPass Micro-Stent (n = 374) or phacoemulsification alone (n = 131).1 All eyes were followed for two years and there was a washout of medications at one and two years (if patients were on medications) to enable the full effect of the device to be determined. In this study, 72.5 per cent of CyPass Micro-Stent group and 58 per cent of the control group achieved a clinically significant reduction in unmedicated IOP at 24 months and this difference was statistically significant.1 The number of patients who were medicationfree at 24 months in the CyPass Micro-Stent group was 85 per cent compared to only 59 per cent in the control group and again this difference was statistically significant.1 Dr. Au also reported the results of the DUETTE study showing that standalone CyPass Micro-Stent insertion significantly reduced IOP in eyes with open-angle glaucoma refractory to medical treatment.2 Lastly, he shared his tips and surgical pearls for successful insertion with the audience.
In Sydney, Dr. Minas Coroneo described what lead him to invent the procedure and Drs. Ashish Agar, Hamish Dunn, and Andrew White participated in a panel discussion. In Brisbane, Drs. Leon Au and Mark Chiang lead a Q&A session about the CyPass Micro- Stent. In Melbourne, I presented data on refractive outcomes of the CyPass Micro-Stent combined with cataract surgery, showing the combined procedure has predictable refractive outcomes and a fast visual recovery comparable to cataract surgery alone. Additionally, I shared the results of a clinical trial we recently published in the American Journal of Ophthalmology showing the benefit of standalone CyPass Micro-Stent insertion in eyes with glaucoma refractory to surgery.3
These are exciting times and patients with mild to moderate primary open-angle glaucoma stand to benefit tremendously from the introduction of the CyPass Micro-Stent through better IOP control, reduced need for glaucoma medication, and lower rates of glaucoma progression.