Effective Date

Date of Origin 

1/1/2024

1/1/2024

MIEBO™

(perfluorohexyloctane)

Ophthalmic solution

Treatment of the signs and symptoms of dry eye disease

1

Dry Eye Disease

Dry eye disease (also known as dry eye syndrome) is a multifactorial disease of the ocular surface with loss of homeostasis of the tear film. It is accompanied by ocular symptoms where tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.(4) The tear film secreting glands and ocular surface function as an integrated system. Disease or dysfunction of this system results in unstable and poorly maintained tear film that causes symptoms of ocular irritation and possible damage to the ocular surface. Dry eye disease may be exacerbated by systemic medications (e.g., diuretics, antihistamines, anticholinergics, systemic retinoids, antidepressants) and rosacea.(2)

Dry eye disease is often associated with Sjogren syndrome, an autoimmune multisystem disorder that most often affects the tear and salivary glands. Tear deficiency may occur in other systemic diseases, such as lymphoma, sarcoidosis, hemochromatosis, and amyloidosis. Dry eye disease may also develop due to systemic viral infections, such as retroviruses, Epstein-Barr virus, and HIV.(2)  

The American Academy of Ophthalmology and the Tear Film and Ocular Surface Society (TFOS) categorized dry eye into three severity levels based on both symptoms and signs. Because of the nature of the disease, this classification is imprecise because characteristics overlap at each level of severity.(2,4,5)

• Mild dry eye: symptoms of irritation, itching, soreness, ocular discomfort, burning or intermittent blurred vision
• Moderate dry eye: increased discomfort and frequency of symptoms, and negative effect on visual function may become more consistent
• Severe dry eye: increasing frequency of visual symptoms that may become constant as well as potentially disabling 

The American Academy of Ophthalmology recommend treating mild dry eye with the following:(2,6)

• Education and environmental modifications
• Elimination of offending topical or systemic medications
• Aqueous enhancement using artificial tear substitutes, gels, or ointment
• Eyelid therapy (warm compresses and eyelid scrubs)
• Treatment of contributing ocular factors such as blepharitis or meibomianitis
• Correction of eyelid abnormality

For treatment of moderate dry eye, the following are recommended in addition to mild dry eye treatment options:(2,6)

• Topical anti-inflammatory agents (topical cyclosporine and corticosteroids), systemic omega 3 fatty acid supplements
• Punctal plugs
• Spectacle side shields and moisture chambers

For treatment of severe dry eye, the following are recommended in addition to mild and moderate dry eye treatment options:(2,6)

• Systemic cholinergic agonists
• Mucolytic agents
• Autologous serum tears
• Therapeutic contact lenses
• Surgical punctal occlusion
• Tarsorrhaphy

Because of the inconsistent correlation between reported symptoms and clinical signs as well as the relatively poor specificity and/or sensitivity of clinical tests, patients with suggestive symptoms without signs should be placed on trial treatments with artificial tears when other potential causes of ocular irritation have been eliminated. As the severity of the dry eyes increases, aqueous enhancement of the eye using topical agents is appropriate. Emulsions, gels, and ointments can be used. The use of artificial tears may be increased, but the practicality of frequent tear instillation depends on the lifestyle or manual dexterity of the patient. Non-preserved tear substitutes are generally preferable; however, tears with preservatives may be sufficient for patients with mild dry eye and an otherwise healthy ocular surface. When tear substitutes are used frequently and chronically (e.g., more than 4 times a day), non-preserved tears are generally recommended. It is imperative to treat any causative factors that are amenable to treatment.(2)

Anti-inflammatory therapies may be considered in addition to aqueous enhancement therapies. However, since dry eye symptoms tend to wax and wane over long periods of time, the lack of long-term data on the effectiveness of cyclosporine and the costs of longer-term (e.g., annual, lifetime) treatment should be weighed.(2)

Pre-treatment with topical ophthalmic corticosteroids either before or during initiation with a non-glucocorticoid anti-inflammatory agent may provide more rapid improvement in symptoms of dry eye disease and decrease the incidence of severe stinging associated with a topical immunomodulator agent compared to a topical immunomodulator alone.(6) The AAO also notes that topical corticosteroid use for dry eye disease is controversial, but note that they can be used for induction therapy prior to initiating non-glucocorticoid anti-inflammatory agents for maintenance therapy. Once the patient is in a successful maintenance phase, steroids are used for acute flare-ups triggered by travel, allergies, respiratory infections, or exposures to environmental irritants with maintenance therapy.(7)

The Sjogren’s Syndrome Foundation’s Clinical Practice Guidelines on Ocular Management in Sjögren’s Patients states the following:(3)

• Management depends upon the nature of the dry eye and the severity of symptoms. 
• In early disease, tear replacement with topically applied artificial tear or lubricant solutions may be sufficient, but progressive or more severe inflammation of the lacrimal gland and ocular surface occur both as an inciting event in many cases and as a secondary effect as the dry eye disease worsens, called keratoconjunctivitis sicca (KCS), requires the use of dietary supplements (omega 3 essential fatty acids), anti-inflammatory measures (e.g., topical corticosteroids or cyclosporine), or oral secretagogues.
• Plugging of the lacrimal puncta can be done once the inflammatory component of dry eye is controlled. Control of lid margin (meibomian gland) disease may require topical antibiotic or systemic doxycycline therapy. The most severe cases of dry eye, particularly those unresponsive to more standard therapy, may require use of topical autologous serum or partial closure of the interpalpebral fissure to reduce surface exposure. Scleral contact lenses may be needed to control severe ocular surface damage.

Safety

Perfluorohexyloctane ophthalmic solution has no FDA labeled contraindications for use.(1)  

1

Miebo prescribing information. Bausch & Lomb Inc. May 2023. 

2

Dry eye syndrome Preferred Practice Pattern. American Academy of Ophthalmology. October 2018. https://doi.org/10.1016/j.ophtha.2018.10.023

3

Ocular Management in Sjögren’s Patients. Sjögren’s Syndrome Foundation’s Clinical Practice Guidelines. https://sjogrens.org/sites/default/files/inline-files/SF_CPG-Ocular_2022_0.pdf

4

Craig, J. P., Nichols, K. K., Akpek, E. K., Caffery, B., Dua, H. S., Joo, C.-K., Liu, Z., Nelson, J. D., Nichols, J. J., Tsubota, K., & Stapleton, F. (2017). TFOS DEWS II definition and classification report. The Ocular Surface, 15(3), 276–283. https://doi.org/10.1016/j.jtos.2017.05.008 

5

Wolffsohn, J. S., Arita, R., Chalmers, R., Djalilian, A., Dogru, M., Dumbleton, K., Gupta, P. K., Karpecki, P., Lazreg, S., Pult, H., Sullivan, B. D., Tomlinson, A., Tong, L., Villani, E., Yoon, K. C., Jones, L., & Craig, J. P. (2017). TFOS DEWS II Diagnostic Methodology Report. The Ocular Surface, 15(3), 539–574. https://doi.org/10.1016/j.jtos.2017.05.001 

6

Jones, L., Downie, L. E., Korb, D., Benitez-del-Castillo, J. M., Dana, R., Deng, S. X., Dong, P. N., Geerling, G., Hida, R. Y., Liu, Y., Seo, K. Y., Tauber, J., Wakamatsu, T. H., Xu, J., Wolffsohn, J. S., & Craig, J. P. (2017). TFOS DEWS II management and therapy report. The Ocular Surface, 15(3), 575–628. https://doi.org/10.1016/j.jtos.2017.05.006 

7

Savvy steroid use. American Academy of Ophthalmology. (2016, May 5). https://www.aao.org/eyenet/article/savvy-steroid-use 

Miebo

perfluorohexyloctane ophth soln

1.338 GM/ML

M ; N ; O ; Y

N

Miebo

perfluorohexyloctane ophth soln

1.338 GM/ML

4

Bottles

30

DAYS

Miebo

perfluorohexyloctane ophth soln

1.338 GM/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Miebo

perfluorohexyloctane ophth soln

1.338 GM/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

PA

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. ONE of the following:
   1. The patient has a diagnosis of dry eye disease (i.e., dry eye syndrome, keratoconjunctivitis sicca [e.g., Sjögren’s Syndrome]) AND ONE of the following:
      1. The patient has previously tried or is currently using aqueous enhancements (e.g., artificial tears, gels, ointments [target agents not included]) OR
      2. The patient has an intolerance or hypersensitivity to aqueous enhancements OR
      3. The patient has an FDA labeled contraindication to ALL aqueous enhancements OR
   2. The patient has another FDA labeled indication for the requested agent AND
2. The patient will NOT be using the requested agent in combination with another agent used for dry eye disease (e.g., Restasis, Cequa, Xiidra, Tyrvaya) AND
3. The patient does NOT have any FDA labeled contraindications to the requested agent 

Length of Approval:  2 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
2. The patient has had clinical benefit with the requested agent AND
3. The patient will NOT be using the requested agent in combination with another agent used for dry eye disease (e.g., Restasis, Cequa, Xiidra, Tyrvaya) AND
4. The patient does NOT have any FDA labeled contraindications to the requested agent 

Length of Approval:  12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QL with PA

Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. BOTH of the following:
   1. The requested quantity (dose) exceeds the program quantity limit AND
   2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication  

Length of Approval: Initial - 2 months, Renewal - 12 months