Sight Sciences, Inc. released the 2-year post-surgical outcome data from a large-scale, comparative real-world clinical outcome study assessing patients treated with three forms of minimally-invasive glaucoma surgery (MIGS) techniques.
First things first: give me some background on this study.
Investigators sought to determine real-world outcomes of three popular FDA-approved / cleared ab-interno MIGS technologies (listed below) combined with cataract surgery vs cataract surgery alone:
- Trabeculocanalicular Outflow Restoration (TCOR) using OMNI Surgical System (Sight Sciences)
- Hydrus Microstent (Alcon Vision LLC)
- iStent Inject (Glaukos Corporation)
To note, this comparison was utilized using the American Academy of Ophthalmology (AAO) Intelligent Research in Sight (IRIS) Registry.
Talk about these technologies.
- OMNI Surgical System
- Cleared by the FDA in 2021, it’s the first and currently only implant-free, single-use therapeutic glaucoma device indicated for canaloplasty followed by trabeculotomy in order to reduce intraocular pressure (IOP).
- Hydrus Microstent
- FDA-approved in 2018 , this implantable device is intended for the treatment of open-angle glaucoma and to be used in conjunction with cataract surgery to reduce IOP.
- iStent Inject
- Also FDA-approved in 2018, the procedure can be performed in conjunction with cataract surgery and results in two identical stent devices implanted in the eye to reduce IOP in glaucoma.
Now this study.
Using data from the AAO IRIS Registry, the retrospective analysis identified 109,745 eyes (77,391 patients) having a mild, moderate, or severe glaucoma diagnosis who were treated with a MIGS devices or cataract surgery alone between July 2016 and December 2020 (with a minimum follow-up time of months.)
These patients also had a generally comparable baseline IOP (16.5 mmHg to 17.0 mmHg) and a similar mean number of IOP-lowering medications.
So how many patients were selected?
A total of 9,000 eyes (6,632 patients) received one of the three MIGS procedures in combo with cataract surgery, while the remainder of patients received cataract surgery alone.
For OMNI Surgical System-treated patients, TCOR—an implant-free, ab-interno procedure that pinpoints three primary areas of outflow resistance, according to Sight Sciences—was powered by the system.
What was measured?
The primary outcomes were change in IOP and the number of IOP-lowering medication classes, measured at 6, 12, 18, and 24 months.
These were measured via an analysis stratified by baseline IOP:
- Group 1: > 18mmHg
- Group 2: ≤ 18mmHg
And 24-month findings?
Low baseline IOP (≤18 mmHg) patients treated with the TCOR procedure via the OMNI Surgical System exhibited the greatest numerical reduction in IOP and “a statistically significant greater mean medication reduction compared to all other treatment groups.”
- Pre-op baseline mean IOP = 14.1 mmHg
- Post-op IOP mean reduction = -0.47 mmHg
Further, this patient group required fewer glaucoma medications compared to all other cohorts (MIGS and cataract surgery alone included).
- Pre-op baseline number of medications = 2.01
- Post-op mean medication reduction = -1.42
See the full findings here.
Give me more.
Overall, the investigators found that patients treated with cataract surgery + MIGS showed the following at 24 months compared to those receiving cataract surgery alone:
- Greater medication reduction
- Greater IOP reduction
Conclusions?
The authors concluded that the data “provides longer-term evidence supporting the durable effectiveness of three FDA-approved/cleared MIGS devices.”
However, they noted that the data also demonstrated differences between these devices.
Lastly .. wasn’t there just a study done on the OMNI?
Indeed! Sight Sciences previously released positive 2-year extension data from the ROMEO study supporting the use of the OMNI Surgical System for reducing IOP in primary open-angle glaucoma (POAG) patients. Read that data here.
These findings were presented at the 41st Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) in Vienna, Austria which took place on September 8-12, 2023.