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Can Miebo be Used Long Term for Chronic Dry Eye?

4 min read

Clinical trial data, including a 52-week extension study (KALAHARI), has shown that can Miebo be used long term for treating chronic dry eye disease, with maintained efficacy and a favorable safety profile over one year. This offers a significant option for patients suffering from the evaporative form of the condition.

Quick Summary

Miebo is a safe and effective treatment for the long-term management of chronic evaporative dry eye, with clinical studies supporting its sustained efficacy and excellent tolerability over 52 weeks.

Key Points

  • Long-term Safety Confirmed: The KALAHARI study provided 52-week data confirming Miebo's safety and excellent tolerability for continuous, long-term use in adults with dry eye disease.

  • Sustained Efficacy: Efficacy in improving dry eye signs and symptoms, observed in initial trials, was consistently maintained throughout one year of continuous use.

  • Targets Evaporation: Miebo's unique mechanism of action addresses the root cause of evaporative dry eye by reducing tear film evaporation, not just adding moisture.

  • Favorable Side Effect Profile: The most common adverse effects, such as temporary blurred vision and eye redness, are mild, transient, and do not typically lead to discontinuation.

  • Preservative-Free Formula: As a preservative-free solution, Miebo is suitable for frequent, long-term use, especially for those with sensitive eyes.

  • Combines with Other Therapies: Miebo can be used in conjunction with other dry eye treatments and lifestyle modifications for a comprehensive management approach.

In This Article

Understanding Miebo's Role in Dry Eye Treatment

Dry eye disease (DED) is a common and often chronic condition caused by a loss of tear film stability. This instability can stem from either insufficient tear production (aqueous-deficient dry eye) or excessive tear evaporation. A significant majority of DED patients suffer from evaporative dry eye, which is primarily linked to meibomian gland dysfunction (MGD). The meibomian glands produce a lipid-rich layer, known as meibum, which is crucial for preventing the tear film from evaporating too quickly.

Miebo (perfluorohexyloctane ophthalmic solution) is a prescription eye drop specifically designed to address this evaporative component of DED. Unlike traditional lubricating drops that simply add moisture, Miebo acts by forming a thin, protective layer over the tear film to reduce evaporation. It mimics the key functions of natural meibum, helping to restore the stability of the tear film and protect the ocular surface.

A key advantage of Miebo is its unique formulation. It consists of a single ingredient, perfluorohexyloctane, and is completely preservative-free, which is particularly beneficial for patients with sensitive eyes or those who use eye drops frequently. Its anti-evaporative action and gentle nature make it a strong candidate for long-term management of chronic dry eye.

Evidence for Long-Term Safety and Efficacy

The question of whether can Miebo be used long term is directly addressed by robust clinical trial data. Following two initial 57-day pivotal trials (GOBI and MOJAVE), a 52-week open-label extension study, known as KALAHARI, was conducted to evaluate the long-term safety and efficacy of Miebo.

The KALAHARI study followed 208 patients who had completed the GOBI trial, administering Miebo for a full year. The results provided strong evidence that Miebo is suitable for extended use.

Key findings from the KALAHARI study include:

  • Sustained Efficacy: Patients who continued Miebo treatment maintained improvements in both objective signs (total corneal fluorescein staining) and subjective symptoms (eye dryness score) that were observed in the initial trials.
  • Excellent Safety Profile: The medication was well-tolerated over the 52-week period. The primary safety endpoint showed a favorable incidence of ocular and non-ocular adverse events.
  • Low Side Effect Incidence: The rate of side effects remained low, consistent with the initial pivotal trials, reinforcing its suitability for chronic application.

This long-term data provides reassurance that Miebo is not merely a temporary fix but a durable option for managing chronic DED. Its mechanism of addressing the root cause of tear evaporation allows for sustained relief of symptoms and continued healing of the ocular surface over time.

Miebo vs. Other Dry Eye Treatments: A Comparison

To understand Miebo's unique position in the dry eye treatment landscape, it's helpful to compare it with other prescription options, such as anti-inflammatory drops.

Feature Miebo (Perfluorohexyloctane) Other Prescription Drops (e.g., Xiidra, Restasis)
Mechanism Forms a protective, anti-evaporative layer to stabilize the tear film's lipid layer. Reduces inflammation associated with dry eye disease.
Primary Target Evaporative dry eye caused by meibomian gland dysfunction (MGD). Aqueous-deficient dry eye and inflammatory dry eye.
Onset of Action Symptom relief can begin as early as 2 weeks, with continued improvement over time. Takes several weeks to months to see full effect.
Preservative-Free Yes, Miebo is composed of a single ingredient with no preservatives, making it gentle on sensitive eyes. May or may not be preservative-free depending on the specific product formulation.
Combination Use Can be used in conjunction with other treatments like punctal plugs or other eye drops, as advised by a doctor. Can be combined with other therapies, requiring staggered administration.

What to Expect During Long-Term Miebo Use

When starting Miebo, some patients may notice that the drop feels different from water-based solutions, and there may be no immediate ocular sensation upon instillation. With consistent, long-term use as prescribed by a healthcare professional, most patients experience significant and sustained symptom relief.

The most common ocular adverse reactions reported in clinical trials were mild and transient, including blurred vision and conjunctival redness, each affecting 1-3% of individuals. These side effects generally do not lead to treatment discontinuation. The product has a favorable tolerability profile, which is crucial for a medication intended for chronic use.

Other considerations for long-term use include:

  • Contact Lenses: Contact lenses must be removed before administering Miebo and can be reinserted at least 30 minutes after application.
  • Adjunctive Therapy: Miebo can be a powerful standalone treatment but can also be effectively integrated with other dry eye therapies, such as warm compresses, eyelid scrubs, and punctal plugs. In fact, some eye doctors find it can be synergistic with other treatments.
  • Cost: Without insurance, Miebo can be expensive. However, patient assistance and copay programs are available to help eligible patients manage costs.

Conclusion: Is Miebo a Long-Term Solution?

For patients with chronic evaporative dry eye, the answer is a resounding yes. The extensive clinical data, particularly from the 52-week KALAHARI extension study, provides clear evidence that Miebo is safe and effective for long-term, continuous use. By directly targeting the root cause of excessive tear evaporation, Miebo offers a durable solution that not only provides symptom relief but also promotes the long-term health and stability of the ocular surface. Given its preservative-free formula and favorable safety profile, it stands as a significant advancement in the management of chronic DED. As with any prescription medication, it is essential to consult with an eye care professional to determine if Miebo is the right long-term treatment for your specific condition.

Miebo Prescribing Information

Frequently Asked Questions

The longest clinical trial for Miebo was the KALAHARI study, a 52-week (one-year) open-label extension trial that evaluated the long-term safety and efficacy of the eye drop.

Long-term data from the KALAHARI study showed a favorable safety profile, with adverse events being mostly mild to moderate and consistent with findings from the initial trials. No serious long-term side effects were reported.

Miebo specifically targets tear evaporation, whereas Restasis and Xiidra primarily target inflammation. Miebo has demonstrated sustained efficacy and safety for at least one year of continuous use, offering a distinct, evaporation-focused option for long-term dry eye management.

Dry eye is often a chronic condition. Consistent use of Miebo helps manage the symptoms by stabilizing the tear film. If treatment is discontinued, symptoms may return, as the underlying condition is not permanently cured.

Yes, you can wear contact lenses while on long-term Miebo treatment. However, you must remove your lenses before administering the drops and wait at least 30 minutes before reinserting them.

Miebo is a single-ingredient, preservative-free solution. This formulation makes it well-suited for long-term and frequent use without the potential irritation caused by preservatives found in other drops, benefiting individuals with sensitive eyes.

Based on the recommended administration, a bottle of Miebo contains enough drops for approximately a one-month supply.

The available clinical trial data extends to one year and confirms safety within that timeframe. Miebo is not metabolized and does not accumulate in tissues. It is not currently linked to long-term accumulation or negative health effects associated with certain chemical classes.

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.