Safety and Efficacy of Omidenepag Isopropyl for Elevated Intraocular Pressure: A Systematic Review and Meta-Analysis.

Purpose

We synthesized the literature to assess the safety and efficacy of Omidenpag isopropyl (OMDI) in comparison to prostaglandin F(FP) agonists used in glaucoma management DESIGN: Systematic review and meta-analysis.

Methods

We searched MEDLINE, EMBASE and CENTRAL from inception to November 2024. Meta-analyses were conducted using fixed-effects models for ocular adverse events (AEs), with pooled risk ratios (RRs), and random-effects models for intraocular pressure (IOP) changes, with weighted mean differences (WMDs). Results are presented as 95% confidence intervals (CIs) and P-values.

Results

Of the 358 studies screened, 17 studies (n = 3294 eyes) were included, yielding 5 RCTs, 7 retrospective cohort studies and 5 prospective cohort studies. Most studies were uncontrolled with variable follow-ups (9.3 ± 8.7 months). The mean age was60.8 ± 11.7 years, and 44.73% were male (n = 1318). The primary efficacy outcome was the change in IOP from baseline. 4 studies indicated no significant difference in IOP reduction between OMDI and FP agonists (WMD = 0.28 mmHg, 95% CI [-0.09 to 0.65], P = .144). 17 studies reported a significant reduction in IOP from baseline with OMDI (WMD = -3.78 mmHg, 95% CI [-4.74 to -2.82], P < .001). Overall ocular AEs may have been higher in patients treated with OMDI when compared to FP receptor agonists (RR = 1.16, 95% CI [0.94 to1.43], P = .170), which became significant with the exclusion of 1 study with a marked effect favoring OMDI (1.46 (95% CI: [1.17 to 1.83], P < .001). Incidence of conjunctival hyperemia (14.0% vs 6.8%) and corneal changes (6.7% vs 3.3%) were higher in the OMDI group (P < .05). However, there were less eyelash (0.0% vs 3.0%, P = .003) and eyelid/orbital side effects (0.0% vs 2.8%, P = .013) with OMDI.

Conclusion

OMDI 0.002% offers an alternative to FPs for IOP management especially when FPs may not be effective or suitable. While its efficacy is comparable, clinicians must consider the increased risk of AEs with OMDI. Short follow-up periods constrained the assessment of long-term efficacy and rare AEs; however, the absence of eyelash-related changes and prostaglandin associated periorbitopathy offers a cosmetic advantage over FPs. Further research could identify patient subgroups who may benefit from OMDI treatment.