This month, News in Review highlights selected papers from the original papers sessions at AAO 2020 Virtual. Each was chosen by the session chairs because it presents important news or illustrates a trend in the field. For details of presentation times, check the Virtual Meeting Guide at either aao.org/2020 or in the virtual meeting platform.
A Japanese mandatory postmarketing observational study has confirmed the safety and efficacy of omidenepag isopropyl ophthalmic solution 0.002% (OMDI), a topical drug used to treat elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.1
Two years ago, OMDI (Eyebelis, Santen) received the first global approval in Japan, based on results from phase 3 clinical trials.2 In this observational study, conducted in a real-world setting, researchers report significant IOP lowering effects and no significant safety concerns. “These results will enhance the proper use of this drug for glaucoma patients,” said Toru Nakazawa, MD, PhD, at Tohoku University School of Medicine in Sendai City, Japan.
Mechanism of action. Although OMDI is not a prostaglandin, it binds selectively to the prostaglandin EP2 receptors, and it increases the pathway of aqueous humor outflow through both the trabecular and uveoscleral outflow pathways.
“In the clinical trials, OMDI showed noninferior IOP reduction compared to latanoprost and timolol,” Dr. Nakazawa said. “And it showed no specific adverse reactions commonly found in prostaglandin analogs, like eyelid/iris pigmentation or deepening of upper eyelid sulcus.”2
The earlier clinical trials also found OMDI to be safe and effective as an adjunct to beta blockers; in addition, it was shown to be safe and effective for patients who do not respond well to latanoprost (≤15% IOP reduction).
Observational study. The latest findings are based on a review of the medical records of 981 patients at hospitals and clinics throughout Japan. Of the patients evaluated, 32.8% had primary open-angle glaucoma, 59.1% had normal tension glaucoma, and 5.2% had ocular hypertension naive to treatment.
On average, the patients experienced a reduction in IOP from a baseline of 16.6 mm Hg to 13.8 mm Hg at seven months. They will continue to be observed for 12 months, Dr. Nakazawa said.
A total of 167 patients (17.0%) experienced adverse reactions. Although most adverse effects were not serious, one case of macular edema was observed. (In the clinical trials of the drug, aphakic or pseudophakic patients had an increased risk of developing macular edema.)
What’s next. This postmarketing study will run to 2022, with a target of 3,900 patients. “In the near future, we will be able to analyze this study data with a larger patient population,” Dr. Nakazawa said. “This may possibly reveal more detailed safety information, including risk factors for both identified safety concerns and unexpected adverse reactions, which might not have been detected earlier.”
1 Nakazawa T et al. Safety and efficacy of omidenepag isopropyl in multicenter observational study in Japan—interim result. Presented at: AAO 2020 Virtual; Nov. 13-15, 2020.
2 Duggan S. Drugs. 2018;78(18):1925-1929.
Relevant financial disclosures—Dr. Nakazawa: Canon: S; Daiichi-Sankyo: S; Kowa: S; Nidek: S; Rhoto Pharmaceutical: S; Santen: C,L,S; Senju Pharmaceutical: C,L,S: Tomey: S; Topcon: S; Wakamoto Pharmaceutical: S.
For full disclosures and the disclosure key, see below.
Full Financial Disclosures
Dr. Nakazawa Canon: S; Daiichi-Sankyo: S; Kowa: S; Nidek: S; Rhoto Pharmaceutical: S; Santen: C,L,S; Senju Pharmaceutical: C,L,S: Tomey: S; Topcon: S; Wakamoto Pharmaceutical: S.
Dr. Riemann AGTC: S; Alcon: C,L,S; Alimera: C,LS; Alimera Deutschland: C,L; Allergan: L,S; Aniridia Foundation International: C; Animal Eye Institute: C; Aerpio: S; Bausch + Lomb/Valeant: C,L; BioTime/Lineage: C,S; BMC/Eyetube: C; Chengdu Kanghong: S; CSTLII: L; Chruman Research: O; Clearside: S; Clovernook Center for the Blind and Visually Impaired: C; CVP (CEI Vision Partners): O; Digital Surgery Systems: O; Gore: C; Genentech/Roche: S; Gyroscope: C, S; Haag-Streit: C; Haag-Streit Surgical: C; Haag-Streit USA: C,L,P; HumanOptics: C; IamC2: C,P; iVeena: C,O; Janssen /Johnson & Johnson: C,P,S; Kaleidoscope Engineering: C,P; Lowy-MacTel Registry: S; Med One: C,P; Macor Industries: O; Northmark Pharmacy: O; Neurotech: S; Nightstar/Biogen: S; Novartis: S; Notal Vision: C,S; Novartis: L; Opthotech/Iveric: S; Orbit BioMedical: C; Regeneron: L,S; Reliance Industries: C,L,P; SalutarisMD: C,L; Spark: S; TrueVision: C,L,P; VEO: O; Vortex Surgical: C,O,P.
Dr. Shousha NEI: S; Research to Prevent Blindness: S; Resolve Ophthalmics: O. Related patents and PCT are owned by the University of Miami and licensed to Resolve Ophthalmics.
Dr. Yu-Wai-Man GenSight Biologics: C.
||Consultant fee, paid advisory boards, or fees for attending a meeting.
||Employed by a commercial company.
||Lecture fees or honoraria, travel fees or reimbursements when speaking at the invitation of a commercial company.
||Equity ownership/stock options in publicly or privately traded firms, excluding mutual funds.
||Patents and/or royalties for intellectual property.
||Grant support or other financial support to the investigator from all sources, including research support from government agencies (e.g., NIH), foundations, device manufacturers, and/or pharmaceutical companies.
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