Safety and Efficacy of Omidenepag Isopropyl for Elevated Intraocular Pressure: A Systematic Review and Meta-Analysis
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.013 | 0.031 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.021 | 0.038 |
| Bibliometrics | 0.008 | 0.007 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".