Sight Sciences Announces New MIGS Data Demonstrating TCOR Using OMNI Surgical System Lowers IOP and Medication Use at 2 Years
Sight Sciences announced the results of the large scale, comparative real-world clinical outcomes study of patients treated by three leading minimally invasive glaucoma surgery (MIGS) technologies, which were recently presented at the 41st Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) in Vienna, Austria.
Using the American Academy of Ophthalmology IRIS Registry, the largest specialty society clinical data registry in all of medicine, this large-scale MIGS study evaluated long-term 2-year post-surgical outcomes among patients with glaucoma treated with the three most commonly used FDA approved/cleared ab interno MIGS devices in the US (OMNI Surgical System, Hydrus Microstent, and iStent inject) combined with cataract surgery, as well as for cataract surgery alone.
Trabeculocanalicular Outflow Restoration (TCOR) powered by OMNI Surgical System technology describes an implant-free, ab interno procedure that comprehensively addresses the three primary points of outflow resistance, according to Sight Sciences. OMNI technology has been cleared by the FDA for canaloplasty followed by trabeculotomy to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
Baseline Patient Characteristics:
- The entire study cohort consisted of 77,391 glaucoma patients and 109,745 glaucomatous eyes
- 6,632 patients and 9,000 eyes received a MIGS procedure in combination with cataract surgery and the remainder received cataract surgery alone
- The full study patient population was homogenous. Each cohort at baseline had a similar mean IOP and a similar mean number of IOP-lowering medications (see table below)
- The primary treatment goal for the high baseline IOP group was IOP reduction, with a secondary goal to reduce medication burden. The primary treatment goal for the low baseline IOP group was to reduce medication burden
- the greatest numerical reduction in IOP, and
- the greatest numerical reduction in medication use
At 24 months, low baseline IOP (≤18 mmHg) patients who received the TCOR procedure using OMNI technology had:
- the greatest numerical reduction in IOP, and
- a statistically significant greater mean medication reduction compared to all other treatment groups at 24 months
Link to full presentation: https://ssi.onl/3PXM0He
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“Many industry stakeholders have asked us how OMNI compares to other MIGS technologies in the real-world. To better understand the clinical value proposition of the most commonly used MIGS technologies, we collaborated with Verana Health to leverage the IRIS Registry to create what we believe is the most comprehensive MIGS dataset ever assembled," said Paul Badawi, co-founder and CEO of Sight Sciences. "Independent data from the IRIS Registry is valuable and we believe it will inform surgeons’ decision-making when considering the best treatment option for their glaucoma patients. We look forward to sharing this analysis and educating Medicare and healthcare insurers about the TCOR comprehensive MIGS procedure enabled by OMNI technology. Consistent with our many prior published peer-reviewed studies, the TCOR procedure delivers clinically meaningful and durable reductions in both intraocular pressure and medication use."