Omidenepag Isopropyl Versus Timolol in Patients With Glaucoma or Ocular Hypertension: Two Randomized Phase 3 Trials (SPECTRUM 4 and 3).
Bacharach Jason, Brubaker Jacob W, Evans David G, Lu Fenghe, Odani-Kawabata Noriko, Yamabe Takaharu, Wirta David L
AI Summary
Two studies found omidenepag isopropyl effectively lowers IOP in glaucoma/OHT, non-inferior to timolol over 3 months, with sustained 12-month efficacy, offering a new treatment option.
Abstract
Purpose
The SPECTRUM 4 and 3 studies assessed the intraocular pressure (IOP)-lowering efficacy and safety of omidenepag isopropyl (OMDI) 0.002% vs timolol 0.5% in patients with glaucoma or ocular hypertension (OHT).
Design
Phase 3, randomized, controlled, double-masked, noninferiority studies.
Methods
Multicenter studies in the US. Inclusion criteria for adults ≥ 18 years (SPECTRUM 4 [N = 409] and 3 [N = 413]) were open-angle glaucoma or OHT, and IOP ≥ 22 mm Hg and ≤ 34 mm Hg; and for pediatric patients < 18 years (N = 13, SPECTRUM 3) were pediatric glaucoma or OHT. The primary objective in both studies was OMDI noninferiority to timolol in reducing IOP (3 months). SPECTRUM 3 included an additional 9 months of OMDI treatment. Safety evaluations were of ocular/non-ocular adverse events (AEs).
Results
The IOP-lowering range of OMDI remained consistent in SPECTRUM 4 and 3 (-5.6 to -5.9 vs -5.3 to -5.7 mm Hg, respectively); however, timolol efficacy varied (-5.4 to -6.1 vs -6.4 to -7.0 mm Hg, respectively). OMDI noninferiority was achieved in SPECTRUM 4. Efficacy was maintained with 12-month treatment in SPECTRUM 3. Both studies reported more ocular AEs with OMDI, but lower rates of appearance-altering AEs vs timolol. No new safety concerns were identified. Rates of macular edema in pseudophakic patients increased with prolonged OMDI exposure.
Conclusions
SPECTRUM 4 and 3 demonstrated consistent 3-month IOP-lowering efficacy and safety of OMDI vs timolol in patients with glaucoma or OHT. The 12-month data from SPECTRUM 3 suggest OMDI may have long-term benefits in patients with glaucoma or OHT.
MeSH Terms
Shields Classification
Key Concepts6
Omidenepag isopropyl (OMDI) 0.002% demonstrated consistent intraocular pressure (IOP)-lowering efficacy in the SPECTRUM 4 and 3 studies, with a range of -5.6 to -5.9 mm Hg in SPECTRUM 4 and -5.3 to -5.7 mm Hg in SPECTRUM 3.
Omidenepag isopropyl (OMDI) 0.002% achieved noninferiority to timolol 0.5% in reducing intraocular pressure (IOP) at 3 months in patients with glaucoma or ocular hypertension in the SPECTRUM 4 study.
Efficacy of omidenepag isopropyl (OMDI) 0.002% was maintained with 12-month treatment in patients with glaucoma or ocular hypertension in the SPECTRUM 3 study.
Both SPECTRUM 4 and 3 studies reported more ocular adverse events (AEs) with omidenepag isopropyl (OMDI) 0.002% but lower rates of appearance-altering AEs compared to timolol 0.5% in patients with glaucoma or ocular hypertension.
Rates of macular edema in pseudophakic patients increased with prolonged omidenepag isopropyl (OMDI) 0.002% exposure in the SPECTRUM 3 study.
Timolol 0.5% showed varied intraocular pressure (IOP)-lowering efficacy across the SPECTRUM 4 and 3 studies, with a range of -5.4 to -6.1 mm Hg in SPECTRUM 4 and -6.4 to -7.0 mm Hg in SPECTRUM 3.
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