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: Sustained-Release Therapies (Part 1)
Lessening Glaucoma Treatment Burden: Sustained-Release Therapies (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. The bimatoprost implant is a novel treatment option providing durable IOP [intraocular pressure] lowering. Let’s take a look at the clinical data for this implant and its use in patients with early- to moderate-stage glaucoma.
The efficacy and safety of 2 doses of bimatoprost biodegradable drug-eluting implant compared to topical timolol was examined in two 20-month, phase 3, randomized clinical trials. The ARTEMIS studies enrolled adults with open-angle glaucoma and ocular hypertension who were known responders to topical beta-blockers and prostaglandin analogs.
Inclusion criteria also included baseline intraocular pressures between 22 and 32 mmHg at 8:00 AM and between 19 and 32 mmHg 2 hours thereafter, when topical timolol might be expected to reach peak efficacy. Another inclusion criteria was central corneal endothelial density of greater or equal to 1,800 cells per mm2. Participants were randomized to implants containing either 10 or 15 μg of bimatoprost or to topical timolol, 0.5%, administered twice daily. Implants were injected into the interior chamber on day 1, then again on weeks 16 and 32. Primary endpoints were IOP and IOP changes from baseline at weeks 2, 6, and 12. Long-term efficacy and safety profiles, after repeated administration, was evaluated through month 20.
By week 12, patients randomized to both strengths of the bimatoprost implant achieved IOP reductions from approximately 24 to 17 mmHg, representing a 30% reduction from baseline. In both trials, both strength of the bimatoprost implant met predefined criteria of not inferiority compared to timolol. The implant demonstrated statistical noninferiority of timolol with respect to IOP lowering in the 12 weeks after the second and the third injections. A Kaplan-Meier survival analysis estimated a probability of not requiring additional treatment for 1 year after the last implant injection to be in the range of 70%-75% for participants.
The most common treatment emergent adverse events were conjunctival hyperemia, ocular irritation, foreign body sensation, and conjunctival hemorrhages, most of which were thought to be related to the injection protocol and the use of Povidone-iodine antiseptic on the ocular surface. Corneal endothelial cell loss, edema and iritis were more frequent following bimatoprost implant administration compared to topical timolol. In particular, corneal endothelial cell density showed time-dependent loss in study eyes in the bimatoprost implant groups, with greater loss in the 15- compared to the 10-μg group. This difference was thought to be in part related to the larger size of the 15-μg implant.
Based on trial results, the bimatoprost implant 10 μg is approved for a single intracameral administration for IOP control in patients with open-angle glaucoma and ocular hypertension. It was shown to be noninferior to timolol with respect to IOP lowering after 12 weeks, and endothelial cell loss was reported to be in the range of 5% after repeat injections in 20 months of follow-up.
In summary, the bimatoprost implant is a good option for decreasing the burden of daily medication administration and has the potential to minimize ocular surface adverse effects in prostaglandin responders.
It is contraindicated in individuals with active or suspected ocular or periocular infections, corneal endothelial cell dystrophy, prior corneal transplantation, absent or ruptured posterior lens capsules, and in individuals with a history of hypersensitivity to bimatoprost.
Well, that’s all the time we have for 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.
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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.
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