Sight Sciences, Inc. announced new data on its proprietary glaucoma technology: the OMNI Surgical System.
The latest findings are being presented during the 2024 American Society of Cataract and Refractive Surgeons (ASCRS) / American Society of Ophthalmic Administrators (ASOA) annual meeting.
Let’s start with this OMNI Surgical System.
This system was FDA-cleared in 2021 as the first—and still currently only—implant-free, single-use therapeutic glaucoma device indicated for canaloplasty followed by trabeculotomy.Its purpose: to reduce intraocular pressure (IOP) in adults with primary open-angle glaucoma (POAG)
How it works: by opening and potentially restoring flow through the three points of known resistance within the conventional outflow pathway (trabecular meshwork, Schlemm’s canal, and collector channels) of the eye via a single, clear corneal microincision.
What else to know about it?
In March 2023, Sight Sciences launched the Ergo-Series for the OMNI, which features a new design that builds on the original system by incorporating an additional three features.
Click here to learn more.
Gotcha. Now on to this study …
First: The original 12-month GEMINI study (NCT03861169) was a prospective, interventional, and multicenter trial that evaluated the efficacy of 360° canaloplasty and 180° trabeculotomy using OMNI in combo with phacoemulsification for mild-to-moderate OAG and visually significant cataract patients.
Those findings: At month 12, 84.2% of eyes achieved IOP reductions >20% from baseline, 80% of eyes were medication-free, and 76% of eyes achieved IOP between 6-18 mmHg.
Conclusion: Canaloplasty and trabeculotomy performed with the OMNI during phaco significantly reduced unmedicated mean diurnal IOP (DIOP) and medication use 12 months postop.
And this 36-month extension?
The follow-up study (NCT05044793) enrolled 66 participants (including those from the original study) with OAG or cataracts; investigators performed the same techniques as the 12-month study on one eye of each patient via OMNI.
Outcome measures included:
- Reduction in mean unmedicated DIOP
- Reduction in mean IOP-lowering medications
- Percent of eyes with ≥20% reduction in unmedicated DIOP
- Percent of eyes with unmedicated DIOP ≥6 and ≤18 mmHg
What were the patients’ baseline IOP?
Medicated IOP was <33 mmHg, while unmedicated mean DIOP (after washout) was 21–36 mmHg.
And the findings?
To note: IOP at the end of the 12-month GEMINI study was 15.6 mmHg.This latest data found that the number of eyes with ≥20% reduction in IOP was 77% and 78% (months 24 and 36) vs 87% at month 12 from GEMINI.
Further, an estimated 68% of patients had an IOP between 6 and 18 mmHg at 24 months and 71% at 36 months.
And in terms of medication?
The study reported that the mean IOP-lowering medications was 1.7 at baseline, which was then reduced to 0.4 (24 months, −1.3) and 0.3 (36 months, −1.4).
Approximately 74% of patients (46/62) were medication-free at 36 months.
Significance?
The study authors stated that, while the 12-month GEMINI study demonstrated the effectiveness of OMNI (with canaloplasty and trabeculotomy) combined with cataract surgery for lowering IOP and medication adherence in OAG, this long-term data “ is key to the decision making in the selection of a surgical treatment.
Thus, they concluded that this latest data demonstrated those original outcomes were sustained through 36 months.
Company input?
Sight Sciences' CEO and co-founder Paul Badawi stated: “In addition to our existing robust body of clinical evidence, we now have additional data showing impressive OMNI results at 36-months, which demonstrate the vital long-term element of OMNI’s efficacy.
And lastly .. where can I learn more about this data?
If you’re attending ASCRS this weekend, you’re in luck!
Arkadiy Yadgarov, MD, is presenting these 36-month findings on Sunday, April 7, at 3:50 pm EST at the BCEC Meeting level 2 room 259A.
The presentation is titled 36-Month Outcomes for Canaloplasty and Trabeculotomy Combined with Cataract Surgery: Extended Follow-up from the Gemini Study.
Note: Sight Sciences is also hosting a red carpet event on Saturday, April 6, from 3:45 to 4:30 pm EST, stop by their booth (#545)!