Omidenepag Isopropyl Versus Timolol in Patients With Glaucoma or Ocular Hypertension: Two Randomized Phase 3 Trials (SPECTRUM 4 and 3) - 07/06/24
, JACOB W. BRUBAKER b, DAVID G. EVANS c, FENGHE LU d, NORIKO ODANI-KAWABATA e, TAKAHARU YAMABE d, DAVID L. WIRTA fHighlights |
• | Omidenepag isopropyl is a hypotensive agent for glaucoma and ocular hypertension. |
• | It is a selective, non-prostaglandin, prostanoid EP2 receptor agonist. |
• | SPECTRUM 4&3 show data for patients with open-angle glaucoma or ocular hypertension. |
• | Here, omidenepag isopropyl showed intraocular pressure-lowering efficacy and safety. |
• | Long-term benefit of omidenepag isopropyl is suggested by SPECTRUM-3 12-month data. |
Résumé |
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.
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Vol 263
P. 23-34 - juillet 2024 Retour au numéro
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