Why was levobunolol discontinued? Understanding the Market and Therapeutic Evolution

October 6, 2025 •

3 min read

While the active ingredient is still available in some forms, specific formulations of levobunolol, such as the 0.25% strength and preservative-free unit-doses, have been discontinued. The decision to withdraw these particular products from the market is a complex story involving business factors, market dynamics, and the evolution of glaucoma treatment.

Quick Summary

Specific formulations of levobunolol, like the 0.25% strength and preservative-free drops, were discontinued due to market factors and the availability of newer, often more convenient, alternatives. Generic versions, however, remain available.

Key Points

Specific Formulations, Not the Entire Drug: Only certain formulations of levobunolol, such as the 0.25% strength and preservative-free unit doses, have been officially discontinued, not the entire drug.
Market Saturation: The market for glaucoma medications has become crowded with newer, more effective, and often more convenient drug classes, reducing the demand for older beta-blocker formulations.
Emergence of Superior Alternatives: Prostaglandin analogs and Rho kinase inhibitors provide viable alternatives to beta-blockers, some offering more robust intraocular pressure (IOP) reduction or once-daily dosing.
Known Systemic Side Effects: Like other topical beta-blockers, levobunolol carries a risk of systemic side effects such as bradycardia and bronchospasm, which is a consideration for treatment, especially in certain patient populations.
Cost-Effectiveness and Business Decisions: Factors like manufacturing costs and perceived value compared to competitors have played a role in the discontinuation of specific levobunolol products.
Generic Availability: Despite the discontinuation of brand-name products like Betagan in some formulations, generic levobunolol hydrochloride is still available and prescribed.

Discontinuation of Specific Formulations

It is a common misconception that the entirety of the drug levobunolol was withdrawn from the market. The reality is more nuanced: manufacturers have strategically discontinued certain product lines. For instance, the preservative-free 0.5% eye drops in 0.4ml unit doses were slated for discontinuation in late 2024, and the 0.25% strength was discontinued earlier. These moves are not uncommon in the pharmaceutical industry and are often driven by economic and market-related factors.

The Impact of Market Saturation

Levobunolol is a nonselective beta-blocker, a class of medication long used to treat elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Its effectiveness has been demonstrated in long-term studies, showing it to be comparable to other beta-blockers like timolol. However, the market for glaucoma treatment has become increasingly crowded with newer drug classes that offer different mechanisms of action, improved side effect profiles, or more convenient dosing schedules. The rise of these alternative therapies reduced the market demand for specific, older formulations of beta-blockers, making them less profitable for manufacturers to produce.

Business Decisions and Cost-Effectiveness

When pharmaceutical companies evaluate their product portfolios, they weigh manufacturing costs against market share and profitability. In a market where multiple equivalent or superior therapeutic options exist, maintaining production of less-used or older formulations becomes less financially viable. For example, studies from the 1990s comparing levobunolol and timolol already highlighted differences in bottle design that led to variations in the number of doses per bottle, suggesting cost-per-drop advantages for some alternatives. Over time, these subtle differences in cost-effectiveness can contribute to strategic decisions to discontinue certain products.

Comparison of Beta-Blockers for Glaucoma

While levobunolol was a long-standing treatment, other beta-blockers, most notably timolol, also play a significant role. The following table provides a comparison based on clinical findings.


Feature	Levobunolol (Betagan)	Timolol (Timoptic)	Newer Alternatives (e.g., Latanoprost)
Drug Class	Nonselective Beta-Blocker	Nonselective Beta-Blocker	Prostaglandin Analog
Mechanism of Action	Decreases aqueous humor production	Decreases aqueous humor production	Increases uveoscleral outflow
Efficacy	Effective at lowering IOP, comparable to timolol	Equally effective at lowering IOP as levobunolol	Highly effective; often provides greater IOP reduction
Dosing Frequency	Twice daily	Often twice daily; once-daily gel options available	Once daily, often at night
Systemic Side Effects	Risk of bradycardia, heart failure, and bronchospasm due to systemic absorption	Similar systemic side effect risks to levobunolol	Fewer systemic side effects; local side effects like redness and eyelash growth more common
Preservative-Free Versions	Discontinued in some unit-dose forms	Available in preservative-free options	Several options available

The Role of Systemic Side Effects

Topical beta-blockers, including levobunolol, can be absorbed systemically, leading to side effects typically associated with oral beta-blockers. These can include bradycardia (abnormally slow heart rate), hypotension, and respiratory issues like bronchospasm, particularly in patients with pre-existing conditions like asthma or chronic obstructive pulmonary disease (COPD). While these side effects were a known risk, they were not the specific reason for the general discontinuation. However, they are significant enough that caution is advised and, in some cases, therapy must be stopped, as highlighted in a case report of a patient experiencing severe bradycardia after using levobunolol. The availability of newer agents with different systemic risk profiles has also contributed to the shift away from older beta-blocker formulations.

The Evolution of Glaucoma Treatment

The landscape of glaucoma therapy has seen a dramatic expansion, moving beyond traditional beta-blockers. The emergence of prostaglandin analogs like latanoprost and bimatoprost, which often offer superior efficacy and once-daily dosing, provided compelling alternatives. More recently, the introduction of novel drugs like Rho kinase inhibitors (e.g., netarsudil) has further diversified treatment options. This evolution has provided clinicians and patients with a wider range of choices, each with its own balance of efficacy, side effects, and convenience, making the older, twice-daily beta-blockers less of a dominant force in the market.

Conclusion

While the drug levobunolol has not been completely discontinued, the withdrawal of specific formulations reflects a larger shift in the ophthalmic drug market. This shift is driven by business decisions to streamline product offerings, the emergence of more convenient and effective drug classes, and the ongoing assessment of side effect profiles. As a result, older, twice-daily formulations of beta-blockers have been superseded by newer treatments. However, generic versions of levobunolol remain available, and it can still be an effective treatment option for some patients under a doctor's supervision. The evolving landscape ensures that patients with glaucoma have a comprehensive and ever-improving array of therapeutic choices.

Frequently Asked Questions

No, levobunolol has not been completely withdrawn from the market. While specific formulations, like the preservative-free 0.5% unit dose, have been discontinued, generic versions of levobunolol hydrochloride remain available with a prescription.

The discontinuation of specific Betagan (levobunolol) formulations, such as the 0.25% strength, was likely a business decision based on market factors. The rise of newer, more popular glaucoma treatments reduced the demand for these particular products, making them less profitable for the manufacturer to produce.

Common alternatives include other beta-blockers like timolol, prostaglandin analogs such as latanoprost and travoprost, carbonic anhydrase inhibitors like dorzolamide, and newer agents like Rho kinase inhibitors (netarsudil).

Clinical studies have shown that levobunolol and timolol are equally effective at lowering intraocular pressure over the long term. Any differences generally relate to bottle design, dosage schedules, or specific patient tolerability, rather than core efficacy.

Because it can be systemically absorbed, levobunolol can cause side effects like slow heart rate (bradycardia), low blood pressure, and, in susceptible individuals, respiratory issues such as bronchospasm. These effects are not unique to levobunolol but are a known risk with all topical beta-blockers.

Patients should not stop their medication abruptly. They should consult with their eye doctor or ophthalmologist to discuss switching to an alternative, which may include a generic version of levobunolol or a different class of medication entirely, depending on their condition and tolerability.

Switching medications should be done under the supervision of a healthcare professional. Your doctor will help you choose an appropriate and safe alternative, such as a different beta-blocker, a prostaglandin analog, or a combination product, based on your medical history and treatment needs.