Emerging drugs for the treatment of glaucoma: a review of phase II &amp; III trials

Kaplan, Tyler M.; Sit, Arthur J.

doi:10.1080/14728214.2022.2110240

Cited by 4 publications

(4 citation statements)

References 95 publications

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“…These constitute pharmaceuticals, implantable AQH shunting devices, and surgeries [ 5 , 6 , 7 , 24 , 115 , 119 , 120 , 121 , 122 ]. Over the years, several classes of compounds have been discovered, tested, pharmacologically characterized, developed into suitable dosage forms, and approved by various world health authorities to impart efficacious ocular hypotensive activity in animal models and glaucoma patients [ 5 , 6 , 7 , 23 , 24 , 25 , 115 , 116 ]. Such pharmaceuticals include miotics (pilocarpine and carbachol; dosed topically ocularly (t.o.)…”

Section: Major Methods To Lower and Control Iop/ohtmentioning

confidence: 99%

“…If the presence of GON is confirmed, the clinician would prescribe eyedrop medication to lower the IOP, perform regular follow-up monitoring of the IOP, and adjust the treatment paradigm as necessary. If the IOP cannot be controlled by one drug and the IOP is reduced to normal levels (14–21 mmHg), adjunctive therapy may be necessary either using single drugs [ 5 , 6 , 7 , 11 , 12 , 14 , 15 , 17 , 20 , 23 , 24 , 25 , 115 , 116 ] or using fixed-dose combination products containing multiple health agency-approved ocular hypotensive drugs [ 117 , 118 ]. If the patient’s IOP is unresponsive to pharmaceutical treatments, then surgery or implantation of tubes or AQH microshunts into the AC of the eye may be necessary to drain the excess AQH [ 119 , 120 , 121 , 122 ].…”

Section: Open-angle Glaucomamentioning

confidence: 99%

“…For brevity and focus, only OAG will be discussed since much of the research and approved drug, device, and surgical treatments have been directed towards this disease, although the latter modalities are also utilized for other types of glaucoma. Since several clinical trials have demonstrated a strong association between OAG and elevated IOP/ chronic OHT (cOHT) [ 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 ], the focus of much research has been to find means to lower and control this modifiable biomarker, thereby slowing the progression of the disease [ 5 , 6 , 7 , 23 , 24 , 25 ].…”

Section: Introductionmentioning

confidence: 99%

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Recently Approved Drugs for Lowering and Controlling Intraocular Pressure to Reduce Vision Loss in Ocular Hypertensive and Glaucoma Patients

Sharif

2023

Pharmaceuticals

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Serious vision loss occurs in patients affected by chronically raised intraocular pressure (IOP), a characteristic of many forms of glaucoma where damage to the optic nerve components causes progressive degeneration of retinal and brain neurons involved in visual perception. While many risk factors abound and have been validated for this glaucomatous optic neuropathy (GON), the major one is ocular hypertension (OHT), which results from the accumulation of excess aqueous humor (AQH) fluid in the anterior chamber of the eye. Millions around the world suffer from this asymptomatic and progressive degenerative eye disease. Since clinical evidence has revealed a strong correlation between the reduction in elevated IOP/OHT and GON progression, many drugs, devices, and surgical techniques have been developed to lower and control IOP. The constant quest for new pharmaceuticals and other modalities with superior therapeutic indices has recently yielded health authority-approved novel drugs with unique pharmacological signatures and mechanism(s) of action and AQH drainage microdevices for effectively and durably treating OHT. A unique nitric oxide-donating conjugate of latanoprost, an FP-receptor prostaglandin (PG; latanoprostene bunod), new rho kinase inhibitors (ripasudil; netarsudil), a novel non-PG EP2-receptor-selective agonist (omidenepag isopropyl), and a form of FP-receptor PG in a slow-release intracameral implant (Durysta) represent the additions to the pharmaceutical toolchest to mitigate the ravages of OHT. Despite these advances, early diagnosis of OHT and glaucoma still lags behind and would benefit from further concerted effort and attention.

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Section: Major Methods To Lower and Control Iop/ohtmentioning

confidence: 99%

Section: Open-angle Glaucomamentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Recently Approved Drugs for Lowering and Controlling Intraocular Pressure to Reduce Vision Loss in Ocular Hypertensive and Glaucoma Patients

Sharif

2023

Pharmaceuticals

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“…Glaucoma refers to a group of related diseases involving optic neuropathy frequently associated with elevated intraocular pressure (IOP) 1,2 . There are several nonmodifiable risk factors for glaucoma, such as family history, ethnicity, and age; the only known modifiable risk factor for glaucoma is elevated IOP 3 . Results from multiple studies demonstrated that treating elevated IOP with ocular hypotensive medications, such as prostaglandin F (FP) receptor agonists (FP agonists, often referred to as prostaglandin analogs), can delay or even prevent glaucoma disease progression and glaucomatous visual field loss 2,4,5 …”

mentioning

confidence: 99%

Omidenepag Isopropyl in Latanoprost Low/Nonresponders With Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 3, Nonrandomized, Two-Phase, Open-Label Study

Panarelli,

Bowden,

Tepedino

et al. 2023

Journal of Glaucoma

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Précis: This study demonstrates the efficacy and safety of once-daily 0.002% omidenepag isopropyl (OMDI) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) who do not respond or respond poorly to latanoprost. Purpose: To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of OMDI in latanoprost low/non-responders with POAG or OHT. Materialsand Methods: Phase 3, non-randomized, two-phase, open-label, multicenter study (NCT03697811) in the United States. Key inclusion criteria included individuals aged ≥18 years, POAG or OHT diagnosis in both eyes, IOP ≥22 mm Hg in ≥1 eye and ≤34 mm Hg in both eyes at all time points. Overall, 107 patients were enrolled; 104 completed treatment. Included a screening period (≤35-day washout period and 8-week latanoprost run-in period) and a 3-month treatment period comprising one drop of OMDI 0.002% once daily in both eyes. Primary study endpoint was change from baseline in mean diurnal (MD) IOP at month 3. Safety endpoints included incidence of adverse events (AEs), serious AEs, and adverse drug reactions. Results: At baseline (visit 4), 75 (70.1%) patients had POAG, 32 (29.9%) had OHT, and 68 (63.6%) had prior use of prostaglandin/prostaglandin analogs (37.4% of whom used latanoprost). Mean (standard deviation [SD]) baseline MD IOP was 23.34 mm Hg (2.12). Mean (SD) 3-month (visit 7) MD IOP change from baseline (following latanoprost run-in period and OMDI treatment period) was an additional decrease of 2.96 mm Hg (2.83) (P<0.0001). No significant safety issues were reported during OMDI treatment. Conclusions: These data demonstrate OMDI efficacy and safety in latanoprost low/non-responders with POAG or OHT, suggesting OMDI is a treatment option in the patient population in this study.

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Currently available prostanoids for the treatment of glaucoma and ocular hypertension: A review

Benitez,

Anter,

Arcuri

et al. 2024

Current Opinion in Pharmacology

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Emerging drugs for the treatment of glaucoma: a review of phase II & III trials

Cited by 4 publications

References 95 publications

Recently Approved Drugs for Lowering and Controlling Intraocular Pressure to Reduce Vision Loss in Ocular Hypertensive and Glaucoma Patients

Recently Approved Drugs for Lowering and Controlling Intraocular Pressure to Reduce Vision Loss in Ocular Hypertensive and Glaucoma Patients

Omidenepag Isopropyl in Latanoprost Low/Nonresponders With Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 3, Nonrandomized, Two-Phase, Open-Label Study

Currently available prostanoids for the treatment of glaucoma and ocular hypertension: A review

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