Search

Tsing Hong Wang,1 Tin Aung,2– 4 Da-Wen Lu,5 Ronnie George,6 Sirisha Senthil,7 Fenghe Lu,8 Noriko Odani-Kawabata,9 Ki Ho Park10 1Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan; 2Singapore Eye Research Institute, Singapore National Eye Centre, Singapore; 3Duke-NUS Medical School, Singapore; 4Department of Ophthalmology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; 5Department of Ophthalmology, Tri-Service General Hospital, Taipei, Taiwan; 6Sankara Nethralaya, Chennai, India; 7VST Centre for Glaucoma Care, Kallam Anji Reddy Campus, Hyderabad, India; 8Santen Pharmaceuticals, Inc, Emeryville, CA, USA; 9Santen Pharmaceuticals, Ltd, Osaka, Japan; 10Department of Ophthalmology, Seoul National University, Seoul, Republic of KoreaCorrespondence: Tsing Hong Wang, Department of Ophthalmology National Taiwan University Hospital, Taipei, Taiwan, Email thwangglaucoma@ntu.edu.twPurpose: To compare the efficacy and safety of omidenepag isopropyl (OMDI) 0.002% with latanoprost 0.005% once daily in Asian subjects with open-angle glaucoma (OAG)/ocular hypertension (OHT).Methods: In this Phase III randomized, observer-masked, active-controlled, multinational trial (NCT02981446), subjects aged ≥ 18 years with OAG/OHT in both eyes and baseline intraocular pressure (IOP) ≥ 22 mmHg and ≤ 34 mmHg were randomized 1:1 to OMDI or latanoprost. IOP was measured at 9AM, 1PM, and 5PM at baseline, 1 week, 6 weeks, and 3 months. Adverse events (AEs) were recorded. Non-inferiority of OMDI to latanoprost was tested for primary and key secondary endpoints.Results: Each group included 185 subjects. Mean diurnal IOP from baseline to month 3 was reduced 7.1 mmHg (28.8%) with OMDI and 7.8 mmHg (31.3%) with latanoprost, with the least-squares mean difference (OMDI minus latanoprost) being 0.6 mmHg (95% CI: 0.0, 1.2 mmHg; p = 0.0366), indicating non-inferiority. Mean IOP reductions at the nine timepoints were − 5.8 to − 7.3 mmHg (23.5– 29.5%) for OMDI and − 6.1 to − 7.9 mmHg (24.3– 31.7%) for latanoprost. Non-inferiority per FDA criteria was also met. Rates of all AEs, ocular AEs, and ocular AEs associated with treatment were 40.0%, 36.8%, and 23.2%, respectively, for OMDI and 29.7%, 21.1%, and 11.9%, respectively, for latanoprost. Conjunctival hyperemia rates were higher with OMDI than latanoprost (11.9% vs 5.4%). Most AEs were mild, with no serious ocular AEs.Conclusion: OMDI safely and effectively reduces IOP in Asian subjects with OAG/OHT, with mean diurnal IOP at Month 3 and per-timepoint IOP reductions non-inferior to those of latanoprost.Plain Language Summary: PEONY Study: Testing How Well and How Safely Omidenepag Isopropyl Eye Drops Treat People with Glaucoma or Ocular Hypertension Compared with Latanoprost.Who took part in the study?Three hundred and seventy participants average age of 57 years, from 34 centers across four Asian countries who had glaucoma or high pressure in both eyes were randomly divided into two groups. One group (185 people; 50%) was given OMDI, and the other group (185 people; 50%) latanoprost for 3 months. The intraocular pressure of both eyes was measured in all participants at three time points (9 AM, 1 PM, and 5 PM) after 1 week, 6 weeks, and 3 months of treatment. The primary endpoint was the average of the daily eye pressure after 3 months of treatment. The safety of OMDI was also assessed.Study results.After 3 months of treatment, OMDI decreased the eye pressure by 29%. This was similar to latanoprost, which decreased the eye pressure by 31% over the same time period. OMDI was safe and well tolerated by those participants who received it. The most common side-effect in people receiving OMDI or latanoprost was conjunctival hyperemia (red eye) (experienced by 22 people receiving OMDI, and 10 people receiving latanoprost).ConclusionsAfter 3 months of use, OMDI was found to safely reduce high eye pressure to a similar level as latanoprost in Asian people with glaucoma or high eye pressure.Keywords: omidenepag isopropyl, latanoprost, intraocular pressure, glaucoma, ocular hypertension