Sight Sciences, Inc. released 2-year results from an extension of the 12-month ROMEO study on the OMNI Surgical System technology for both standalone and combination-cataract surgery.
Give me some background on this system first.
Cleared by the FDA in 2021, the OMNI Surgical System is 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).
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.
Now talk about this trial.
The retrospective, observational, multicenter, evaluation of OMNI (ROMEO) study was a 12-month trial conducted at 11 multi-specialty ophthalmic practices in eight U.S. states.
A total of 81 patients were studied, each with mild-moderate glaucoma who had been treated with circumferential canaloplasty and trabeculotomy (CP+TR).
What was measured?
Patients’ mean IOP, ocular hypotensive medications, and change in number of medications as well as the proportion of patients with a ≥20% reduction in IOP or with IOP ≤18 mmHg, coupled with the proportion of patients able to go medication-free.
Safety outcomes included adverse events (AEs) and secondary surgical interventions (SSIs).
And the original 12-month findings?
A sustained and clinically meaningful reduction of IOP in addition to glaucoma medication use were observed at 12 months among.
AEs included mild inflammation (11%), IOP spikes (5%), and clinically significant hyphema (4%).
Now talk about this 2-year extension.
Of the original 81 patients, 72 (86%) participated in the extension at seven centers across six states.
Patients were either treated with CP+TR with cataract surgery (using the OMNI Surgical System; n = 43) or via a standalone intervention (n = 29), and were divided into two cohorts:
- High baseline IOP (preop IOP > 18 mmHg, n = 34)
- Low baseline IOP (preop IOP ≤ 18 mmHg, n = 38)
The main outcome measures mirrored that of the 12-month study data.
And the findings?
Overall, the 2-year data showed sustained and clinically meaningful reduction for both IOP and glaucoma medications—confirming the 12-month findings.
There were also no reports of serious or unanticipated AEs.
Give me some numbers.
A majority (75%) of the proportion of patients achieved a ≥20% reduction in IOP or IOP between 6 and 18 mmHg and had no increase in medication or secondary surgical intervention (SSI).
Further, one-third of patients (24 of 72) were able to go medication-free (compared to just under 13% of pre-surgical).
Only 8% of patients required additional surgical / laser intervention for IOP control beyond 12 months.
How about the cohorts?
The high-baseline IOP cohort noted a 31% IOP reduction (with an average of 28% for combination-cataract patients; n = 17) while the standalone patients (n =17) had a 17% average IOP reduction.
Overall, a 33% reduction in medication use was observed for all patients.
Any limitations?
The authors noted that, as a retrospective chart review, the study is dependent on data collected during routine medical practice (and not for research purposes)—leading to the potential for missing data and variables that could affect outcomes.
Further, using only 86% of patients from the original study for the follow-up may cause unintended biases; and there was a reported 35% loss to follow-up rate for 24 months.
Significance.
According to Sight Sciences, this 2-year extension is the longest multicenter study of the OMNI Surgical System to date for both standalone and combination-cataract surgery.