First-line treatment for glaucoma is typically pharmacologic and aimed at lowering intraocular pressure, which is the only modifiable risk factor to date. However, successful treatment with traditional topical glaucoma medications may be limited by their well-known barriers of adverse effects and poor patient adherence to drop instillation. Tune in to hear Dr. Qi Cui and Dr. Davinder Grover discuss the novel pharmacological therapies and minimally invasive glaucoma surgery procedures that can lower treatment burden and increase compliance.
Lessening Glaucoma Treatment Burden with Topical Therapies: The Evidence (Part 1)
Lessening Glaucoma Treatment Burden with Topical Therapies: The Evidence (Part 1)
Welcome to CME on ReachMD. This episode is part of our MinuteCME curriculum.
Prior to beginning the activity, please be sure to review the faculty and commercial support disclosure statements as well as the learning objectives.
This is CME on ReachMD, and I’m Dr. Qi Cui. Omidenepag isopropyl is a novel prostaglandin E2 receptor agonist that increases aqueous outflow through the trabecular and the uveoscleral pathways. Let’s dive into the emerging data of this new topical agent.
The AYAME study is a phase 3, randomized, noninferiority trial that evaluated the efficacy and safety of omidenepag isopropyl, abbreviated OMDI, a selective prostaglandin E2 receptor agonist, in Japanese patients with primary open-angle glaucoma or ocular hypertension. The study was completed in 2017, and the results were published in the American Journal of Ophthalmology in 2020. The purpose of the study was to compare the IOP [intraocular pressure]-lowering effects of OMDI ophthalmic solution 0.002% to latanoprost 0.005% at a dose of 1 drop once daily at night for 4 weeks. Eligible patients were age 20 years or older, with a diagnosis of bilateral POAG [primary open-angle glaucoma] or ocular hypertension, with acuity equal to or better than 20/100 on the Snellen chart. Those with advanced visual field loss, recent ocular surgery, a history of ocular inflammation and retinal pathology, or conditions interfering with accurate Goldmann applanation tonometry were excluded. After a washout period of 1-4 weeks, a total of 190 patients were randomized to either OMDI or latanoprost, with 89 completing the study in the OMDI group and 94 completing the study in the latanoprost group. Intraocular pressure was measured at 9:00 AM, 1:00 PM, and 5:00 PM at weeks 1, 2, and 4. The primary endpoint was the change from baseline in mean diurnal IOP at week 4. The noninferiority margin for OMDI compared to latanoprost was determined to be 1.5 mmHg.
Baseline characteristics were comparable between the 2 study groups. At week 4, least squares mean reduction IOP for OMDI, averaging 5.93, plus or minus a standard error of 0.23 mmHg, was found to be noninferior to that of latanoprost, which averaged 6.56, plus or minus a standard error of 0.22 mmHg.
The treatment difference between the 2 groups was statistically, if unlikely to be clinically, significant. No serious adverse events, as determined the by investigators, were observed in either group. The incidence of adverse event was higher in the OMDI group than that in the latanoprost group. The most common ocular adverse events were conjunctival hyperemia, corneal thickening and photophobia, occurring in all cases more frequently in the OMDI group.
In summary, after 4 weeks of treatment, omidenepag isopropyl was shown to be noninferior to latanoprost for intraocular pressure reduction in patients with ocular hypertension or primary open-angle glaucoma, while exhibiting good tolerability.
The RENGE and FUJI studies are two other phase 3 trials conducted in Japan. Results from those trials support the finding of the AYAME study and further suggest that OMDI 0.002% exhibits long-term efficacy whether alone or in combination with timolol 0.5% and may be efficacious in non or poor responders to latanoprost, respectively. Of note, however, a significant percentage of pseudophakic patients in the RENGE study exhibited macular edema after 52 weeks of treatment. Pending long-term efficacy and safety data, omidenepag isopropyl holds promise as a novel IOP-lowering agent for treating glaucoma.
Unfortunately, that’s all the time we have today. Thank you for joining me.
You have been listening to CME on ReachMD. This activity is provided in partnership with the National Eye Institute of the National Institutes of Health, of the U.S. Department of Health and Human Services along with Prova Education, and is part of our MinuteCME curriculum.
To receive your free CME credit, or to download this activity, go to ReachMD.com/Prova. Thank you for listening.
In accordance with the ACCME Standards for Integrity and Independence, Global Learning Collaborative (GLC) requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any ineligible company. GLC mitigates all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs.
Qi Cui, MD, PhD
Assistant Professor of Ophthalmology
University of Pennsylvania
No relevant relationships reported.
Davinder S. Grover, MD, MPH
Glaucoma Specialist, Ophthalmologist
Glaucoma Associates of Texas
Fort Worth, TX
Advisory Board: CATS Tonometer, iSTAR Medical, Sanoculis, Versant Health
Consulting fees: Allergan, New World Medical, Nova Eye Medical, Olleyes, Reichert, Sanoculis
Research: Allergan, New World Medical
- Stephen Chavez has nothing to disclose.
- Cindy Davidson has nothing to disclose.
- Elizabeth Lurwick had nothing to disclose.
- Andrea Mathis has nothing to disclose.
- Colleen Resnick has nothing to disclose.
- Robert Schneider has nothing to disclose.
- Stephanie Wenick, MPhil, has nothing to disclose.
After participating in this educational activity, participants should be better able to:
- Describe topical therapies and sustained-release formulations of antiglaucoma medications that may improve patient adherence
- Recognize minimally invasive glaucoma surgery (MIGS) uses and indications
- Evaluate clinical data of recently approved topical therapies, sustained-release formulations of antiglaucoma medications, and MIGS for patients with early- to moderate-stage glaucoma
- Implement strategies to individualize therapy for patients with early- to moderate-stage glaucoma
This activity is designed to meet the educational needs of ophthalmologists and optometrists.
In support of improving patient care, Global Learning Collaborative (GLC) is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
Global Learning Collaborative (GLC) designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Global Learning Collaborative (GLC) designates this activity for 1 nursing contact hour. Nurses should claim only the credit commensurate with the extent of their participation in the activity.
Prova Education designs and executes continuing education founded on evidence-based medicine, clinical need, gap analysis, learner feedback, and more. Our mission is to serve as an inventive and relevant resource for clinical content and educational interventions across a broad spectrum of specialties.
Prova Education's methodology demonstrates a commitment to continuing medical education and the innovative assessment of its effects. Our goal is clear—to develop and deliver the very best education in the most impactful manner and to verify its results with progressive outcomes research.
This activity is supported by independent educational grants from AbbVie, Inc and Alcon.
The views and opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of GLC and Prova Education. This presentation is not intended to define an exclusive course of patient management; the participant should use his/her clinical judgment, knowledge, experience, and diagnostic skills in applying or adopting for professional use any of the information provided herein. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. Links to other sites may be provided as additional sources of information. Once you elect to link to a site outside of Prova Education you are subject to the terms and conditions of use, including copyright and licensing restriction, of that site.
Reproduction of this material is not permitted without written permission from the copyright owner.
Our site requires a computer, tablet, or mobile device and a connection to the Internet. For best results, a high-speed Internet connection is recommended (DSL/Cable/Fibre). We also recommend using the latest version of your favorite browser to ensure compliance with W3C standards, such as Chrome, Safari, Firefox, or Microsoft Edge.