Sight Sciences Announces the Publication of Large-Scale, Real-World MIGS Study Demonstrating Aqueous Outflow Restorative Procedure with OMNI

Sight Sciences announced the results as published in the American Journal of Ophthalmology (AJO) International of a large scale, comparative real-world clinical outcomes study of patients treated by three leading, minimally invasive glaucoma surgery (MIGS) technologies.

Using the American Academy of Ophthalmology IRIS Registry (Intelligent Research in Sight), the largest specialty society clinical data registry in all of medicine, the MIGS study evaluated long-term 2-year post-surgical outcomes among patients with primary open-angle glaucoma (POAG) treated with the three most commonly used FDA-approved/cleared ab interno MIGS devices in the U.S. (OMNI Surgical System, Hydrus Microstent, and iStent inject) combined with cataract surgery, as well as for cataract surgery alone.

Baseline Patient Characteristics:

• The entire study cohort consisted of 77,391 patients with glaucoma 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 four cohorts had generally similar baseline characteristics in terms of IOP and mean number of IOP-lowering medications (see table below)
• The overall population was divided into two subgroups depending on the baseline, pre-surgical lOP; > 18 mmHg and ≤ 18 mmHg. The primary treatment goal for the high baseline IOP group (> 18mmHg) was IOP reduction, with a secondary goal to reduce medication burden. The primary treatment goal for the low baseline IOP group (< 18mmHg) was to reduce medication burden.

Clinical Outcomes:

• At 24 months, high baseline IOP (>18 mmHg) patients who received the outflow procedure using OMNI technology had:
  • 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 outflow procedure using OMNI technology had:
  • the greatest numerical reduction in IOP, and
  • a statistically significantly greater mean medication use reduction compared to all other treatment groups

“Consistent with our many prior published studies, this large-scale, real-world MIGS dataset from the IRIS Registry, as analyzed by Verana Health and published in a top peer-reviewed journal, corroborates that the OMNI procedure is efficacious as it delivers clinically meaningful and durable reductions in both intraocular pressure and medication use at 2 years," Paul Badawi, co-founder and CEO of Sight Sciences, said in a company news release. "OMNI technology was designed with the goal of restoring the natural outflow process of the eye by addressing the three areas of resistance associated with primary open-angle glaucoma. We are excited to see that large-scale comparison studies of MIGS standards-of-care continue to corroborate the robust IOP reduction and medication reduction associated with the comprehensive OMNI outflow procedure."

Authors and affiliations:

Michael Mbagwu (Stanford University School of Medicine, Palo Alto, CA), Richard Chapman (Verana Health, San Francisco, CA), Kristian Garcia Aesara, Chapel Hill, NC, Aesara, Chapel Hill, NC 3, Jaime E Dickerson Jr (Sight Sciences, Menlo Park, CA, and North Texas Eye Research Institute, University of North Texas Health Science Center, Fort Worth, TX), and Louis B Cantor (Indiana University School of Medicine, Department of Ophthalmology, Indianapolis, IN).

Reference:

Michael Mbagwu, Richard Chapman, Kristian Garcia, Cristina Masseria, Jaime E Dickerson, Louis B Cantor, Ab Interno Minimally Invasive Glaucoma Surgery Combined with Cataract Surgery and Cataract Surgery Alone: IRIS® Registry Study, AJO International, 2024,100015, ISSN 2950-2535.