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Abstract：
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
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). Conclusions After 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
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). Conclusions After 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.
摘要：
■在患有开角型青光眼（OAG）/高眼压症（OHT）的亚洲受试者中，每天一次比较omidenepag异丙酯（OMDI）0.002％与拉坦前列素0.005％的疗效和安全性。
■在此III期随机化中，观察者面具,主动控制，跨国试验（NCT02981446），年龄≥18岁且双眼OAG/OHT且基线眼内压(IOP)≥22mmHg和≤34mmHg的受试者以1:1的比例随机分配至OMDI或拉坦前列素.在上午9点测量眼压，1PM,和基线时下午5点，1周,6周,和3个月。记录不良事件（AE）。针对主要和关键次要终点测试了OMDI对拉坦前列素的非劣效性。
■每组包括185名受试者。OMDI和拉坦前列素从基线到第3个月的平均昼夜眼压降低7.1mmHg（28.8%），7.8mmHg（31.3%）。最小二乘平均差（OMDI减去拉坦前列素）为0.6mmHg（95％CI：0.0，1.2mmHg；p=0.0366），表明非自卑。在9个时间点，OMDI的平均IOP降低为-5.8至-7.3mmHg（23.5-29.5％），拉坦前列素的平均IOP降低为-6.1至-7.9mmHg（24.3-31.7％）。也符合FDA标准的非劣效性。所有AE的比率，眼AE，与治疗相关的眼部不良事件发生率为40.0%，36.8%,和23.2%，分别,对于OMDI和29.7%，21.1%,和11.9%，分别,拉坦前列素.OMDI的结膜充血率高于拉坦前列素（11.9％vs5.4％）。大多数AE是轻度的，没有严重的眼部AE。
■OMDI安全有效地降低了OAG/OHT亚洲患者的IOP，第3个月时的平均昼夜眼压和每个时间点的眼压降低不劣于拉坦前列素。
PEONY研究：测试与拉坦前列素相比，Omidenepag异丙基滴眼液治疗青光眼或高血压患者的安全性和安全性。谁参加了这项研究？三百七十名参与者平均年龄57岁，来自4个亚洲国家的34个中心的双眼有青光眼或高血压的患者被随机分为两组.一组（185人；50％）接受了OMDI，另一组(185人;50%)拉坦前列素治疗3个月。在三个时间点（上午9点，1PM,下午5点)1周后，6周,和3个月的治疗。主要终点是治疗3个月后每日眼压的平均值。还评估了OMDI的安全性。研究结果。治疗3个月后,OMDI使眼压降低29%。这与拉坦前列素相似,在同一时期内，眼压降低了31%。OMDI是安全的，接受它的参与者也很好。接受OMDI或拉坦前列素治疗的患者最常见的副作用是结膜充血（红眼）（接受OMDI治疗的22人经历过，和10人接受拉坦前列素)。结论使用3个月后,发现OMDI可以安全地将高眼压降低到与患有青光眼或高眼压的亚洲人的拉坦前列素相似的水平。
■在此III期随机化中，观察者面具,主动控制，跨国试验（NCT02981446），年龄≥18岁且双眼OAG/OHT且基线眼内压(IOP)≥22mmHg和≤34mmHg的受试者以1:1的比例随机分配至OMDI或拉坦前列素.在上午9点测量眼压，1PM,和基线时下午5点，1周,6周,和3个月。记录不良事件（AE）。针对主要和关键次要终点测试了OMDI对拉坦前列素的非劣效性。
■每组包括185名受试者。OMDI和拉坦前列素从基线到第3个月的平均昼夜眼压降低7.1mmHg（28.8%），7.8mmHg（31.3%）。最小二乘平均差（OMDI减去拉坦前列素）为0.6mmHg（95％CI：0.0，1.2mmHg；p=0.0366），表明非自卑。在9个时间点，OMDI的平均IOP降低为-5.8至-7.3mmHg（23.5-29.5％），拉坦前列素的平均IOP降低为-6.1至-7.9mmHg（24.3-31.7％）。也符合FDA标准的非劣效性。所有AE的比率，眼AE，与治疗相关的眼部不良事件发生率为40.0%，36.8%,和23.2%，分别,对于OMDI和29.7%，21.1%,和11.9%，分别,拉坦前列素.OMDI的结膜充血率高于拉坦前列素（11.9％vs5.4％）。大多数AE是轻度的，没有严重的眼部AE。
■OMDI安全有效地降低了OAG/OHT亚洲患者的IOP，第3个月时的平均昼夜眼压和每个时间点的眼压降低不劣于拉坦前列素。
PEONY研究：测试与拉坦前列素相比，Omidenepag异丙基滴眼液治疗青光眼或高血压患者的安全性和安全性。谁参加了这项研究？三百七十名参与者平均年龄57岁，来自4个亚洲国家的34个中心的双眼有青光眼或高血压的患者被随机分为两组.一组（185人；50％）接受了OMDI，另一组(185人;50%)拉坦前列素治疗3个月。在三个时间点（上午9点，1PM,下午5点)1周后，6周,和3个月的治疗。主要终点是治疗3个月后每日眼压的平均值。还评估了OMDI的安全性。研究结果。治疗3个月后,OMDI使眼压降低29%。这与拉坦前列素相似,在同一时期内，眼压降低了31%。OMDI是安全的，接受它的参与者也很好。接受OMDI或拉坦前列素治疗的患者最常见的副作用是结膜充血（红眼）（接受OMDI治疗的22人经历过，和10人接受拉坦前列素)。结论使用3个月后,发现OMDI可以安全地将高眼压降低到与患有青光眼或高眼压的亚洲人的拉坦前列素相似的水平。
