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DURYSTA (bimatoprost implant)

Policy Number: MP-735

Latest Review Date: June 2023

Category: Vision


Durysta® (bimatoprost implant) is considered investigational for all indications, including when used for the treatment of open angle glaucoma or ocular hypertension.


Durysta® (bimatoprost implant) is described as the first intracameral biodegradable sustained release implant designed to lower intraocular pressure in patients with conditions such as open angle glaucoma or ocular hypertension. The active ingredient involved is bimatoprost, which is a prostaglandin analog medication used to treat glaucoma and lower high eye pressure. Durysta® is composed of biodegradable polymers designed to release bimatoprost in a non-pulsatile, steady-state manner over a 90-day period.

The standard of care treatment for open angle glaucoma or ocular hypertension is eye drops that are self-administered using the following technique:

  • Wash your hands before use
  • Take out contact lenses before using this medicine
  • Do not touch the container tip to the eye, lid, or other skin
  • Tilt your head back and drop drug into the eye.
  • After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for one to two minutes. This keeps the drug in your eye.

A large number of patients report non-compliance with self-administering eye drops due to either forgetfulness or side effects. Durysta®, ocular implant device, has been developed to combat this non-compliance rate.

Durysta® is delivered via a disposable single-use applicator that is inserted into the anterior chamber of the affected eye. Insertion is performed under magnification in an office or ambulatory surgery center. The presence of Durysta® implants has been associated with corneal adverse reactions and increased risk of corneal endothelial cell loss. Per the FDA recommendation, administration of Durysta® should be limited to a single implant per eye without retreatment. Caution should be used when prescribing Durysta® in patients with limited corneal endothelial cell reserve.


This policy was developed with medical literature review through June 9, 2023.

Summary of Evidence

The FDA approval of Durysta is based on results from two 20-month (including eight-month extended follow up) Phase 3 ARTEMIS studies evaluating 1,122 subjects on the efficacy and safety of Durysta versus twice daily topical timolol drops, an FDA accepted comparator for registrational clinical trials, in patients with OAG or OHT. In the two Phase 3 ARTEMIS studies, Durysta reduced IOP by approximately 30 percent from baseline over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator. There are several ongoing studies that have not yet been completed. The ARGOS - A Phase IV, Prospective, 18-month Study to Assess the Effectiveness and Safety of Bimatoprost Intracameral Implant (DURYSTA) in US Clinical Practice ( Identifier: NCT04647214) is currently in recruitment status. This study is a prospective observational study designed to collect effectiveness and safety data after administration of a bimatoprost intracameral implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The study should be completed mid 2023. There remains a paucity of well designed randomized controlled trials proving the efficacy of this technology.

Lowering of IOP is the only proven method to decrease risk of development and/or worsening glaucomatous optic neuropathy. Topical medical therapy is an effective strategy, but many patients are non-adherent to medications.  Barriers to adherence are multifold and include forgetfulness, difficulty with drop instillation, need for frequent administration. Durysta could make an impact on non-compliance glaucoma management issue. There are risks to using Durysta, such as, eye pain, eye irritation, lacrimation, and conjunctival hemorrhage. Studies have shown that Durysta is an effective treatment for glaucoma, but not superior to the standard of care. The FDA clearance is for single use per each eye. In the studies reviewed, Durysta was implanted every four months for one year. At this time the existing evidence is insufficient to prove the medical necessity of this technology.

Practice Guidelines and Position Statements

American Academy of Ophthalmology

The 2015 Primary Open-Angle Glaucoma practice guidance from the American Academy of Ophthalmology recommends switching eye-drop agents or adding on for combination therapy when target IOP is not achieved with one drug alone. The practice guidance has not been updated to include the use of Durysta®  in its recommendations at the time of this review. (As of May 2021, a correction has been issued for the Primary Open-Angle Glaucoma PPP. Corrections do not change the intent of the PPP.)

U.S. Preventive Services Task Force Recommendations

Not applicable.


Durysta®, bimatoprost, biodegradable implant, ocular implant, Allergan, OAG, open angle glaucoma, OHT, ocular hypertension, intracameral administration


On March 4, 2020, the U.S. Food and Drug Administration (FDA) approved Allergan’s Durysta®  (bimatoprost implant) 10 mcg for intracameral administration to treat open-angle glaucoma (OAG) or ocular hypertension (OHT). As per the FDA labeled package insert, Durysta®  (bimatoprost implant) is a biodegradable implant intended for a single administration and should not be re-administered to an eye that received a prior Durysta®  (bimatoprost implant).


Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan. 


CPT Codes:


Injection, anterior chamber of eye (separate procedure); medication

HCPCS Codes:


Injection, bimatoprost, intracameral implant, 1 microgram (Effective 10/1/2020)


HCPCS Codes:

Prior to 10/1/2020, there was not a specific code for Durysta.


Unclassified drugs


  1. American Academy of Ophthalmology Preferred Practice Pattern Glaucoma Panel, Hospkins Center for Quality Eye Care. Primary Open-Angle Glaucoma 2022. Available online at:
  2. Aref, Ahmad A. Durysta (Bimatoprost Implant) Available online at:
  3. Craven ER, Walters T, Christie WC, Day DG, Lewis RA, Goodkin ML, Chen M, Wangsadipura V, Robinson MR, Bejanian M; Bimatoprost SR Study Group. 24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients. Drugs. 2020 Feb; 80(2):167-179. doi: 10.1007/s40265-019-01248-0. 
  4. Gedden SJ, Vinod K, Wright MM, et al. Primary Open-Angle Glaucoma PPP 2020. AAO PPP Glaucoma Committee, Hoskins Center for Quality Eye Care. Nov 2020. Available online at:
  5. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  6. Huang AS, Meyer JJ. Bimatoprost Ophthalmic Solution. 2022 Nov 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan–.
  7. Kolomeyer, Natasha N. Top 7 Things to Know About First Sustained-Release Glaucoma Medication.
  8. Lewis RA, Christie WC, Day DG, Craven ER, Walters T, Bejanian M, Lee SS, Goodkin ML, Zhang J, Whitcup SM, Robinson MR; Bimatoprost SR Study Group. Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 6-Month Results From a Phase I/II Clinical Trial. Am J Ophthalmol. 2017 Mar;175:137-147. doi: 10.1016/j.ajo.2016.11.020. Epub 2016 Dec 22.
  9. Rajan, K. Biodegradable bimatoprost implant gains FDA approval. Available online at:


Medical Policy Group, July 2020 (9): This technology was previously investigational for dates of service prior to July 2020 per MP#495: Investigational Criteria. No change to coverage stance.

Medical Policy Administration Committee, August 2020.

Medical Policy Group, September 2020: Quarterly coding update.  Added code J7351 to Current Coding and moved J3490 to Previous Coding.

Medical Policy Group, April 2021 (9): Updated references. No change to policy statement.

Medical Policy Group, June 2021 (9): 2021 Updates to Key Points, References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, December 2021 (9): Added CPT code 66030 to Current Coding.

Medical Policy Group, June 2022 (9): 2022 Updates to Key Points, References. No change to policy statement.

Medical Policy Group, June 2023 (9): Updates to Key Points, Benefits Application and References. Reviewed by consensus. No new published peer-reviewed literature identified that would alter coverage statement at this time.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.