Omidenepag Isopropyl 0.002% lowers IOP in patients with POAG, OHT
Omidenepag Isopropyl 0.002% (OMDI) significantly lowered intraocular pressure (IOP) in latanoprost low/non-responders with primary open-angle glaucoma (POAG) or ocular hypertension (OHT), according to data from the phase 3 SPECTRUM 5 study presented at the American Academy of Optometry annual meeting (AAOpt) 2022.
In this phase 3 open-label, multicenter study, patients who did not achieve a ≥15% reduction in IOP from the end of a washout period to the end of an 8-week run-in period with latanoprost ophthalmic solution 0.005% once-daily run-in period (n = 107) were treated open-label with OMDI once daily for
3 months. The primary diagnosis of the study eye at baseline was POAG in 75 patients and OHT in 32 patients, with 87 eyes and 20 eyes being phakic and pseudophakic, respectively.
At the end of the latanoprost run-in period the mean (SD) IOP was 23.3 mmHg (2.1) which decreased to 20.5 mmHg (3.3) at month 3.
The mean (SD) change from baseline in IOP of –2.9 mmHg (2.5) at Week 2, –2.9 mmHg (2.6) at Week 6, and–3.0 mmHg (2.9) at Month 3. Change was statistically significant (P < 0.0001) and clinically relevant at Month 3.
There were no reports of significant safety issues or serious adverse events during treatment with OMDI, with the most frequently reported adverse events being conjunctival hyperemia, which was mild in 8 cases and moderately severe in 1 case.
McLaurin EB, et al. Omidenepag Isopropyl 0.002% Significantly Lowers IOP in Latanoprost Low/Non-Responders with POAG or OHT: Phase 3 SPECTRUM 5 study. Presented at: American Academy of Optometry (AAOpt) 2022 meeting.