Summary
The Committee for Medicinal Products for Human Use (CHMP) of the European Union has recommended granting a Marketing Authorization for a new version of Allergan's Lumigan (bimatoprost ophthalmic solution). This new version will be marketed as Lumigan-X after approval. Lumigan X offers Allergan a new formulation to compete against generic versions of its glaucoma drug Lumigan after patent protection for Lumigan expires shortly.
There will be very limited demand for Lumigan-X.
Analysis
Allergan's announcemant that the Committee for Medicinal Products for Human Use has recommended granting a Marketing Authorisation for a new version of Lumigan (bimatoprost ophthalmic solution comes as no surprise. This new version, to be known as Lumigan-X, will be approved in Europe and will also be approved by the U.S. FDA.
Lumigan-X offers Allergan a glaucoma drug with patent protection after the patent on existing Lumigan expires. That expiration will allow generic competition and generic replacement of Lumigan by managed care pharmacy formularies.
Alcon had developed Travatan-Z for similar reasons. Travatan-Z has captured market share from both cannabilization of Travatan and prescriber replacement of Lumigan and Xalatan, the main competition in the prostanoid glaucoma family. All three drugs have equal efficacy. Xalatan has the biggest market share because it was first on the block.
Travatan Z's success, however, has been based on successful marketing of their new formulation which is free of the preservative Benzalkonium Chloride (BAK). Travatan-Z claims that it causes less ocular irritation than Travatan and that the irritation and hyperemia seen with all prostanoids is due to BAK.
Lumigan-X, on the other hand, has no such hook to hold on to or gain market share. The concentration of the drug has been decreased and the BAK preservative remains. Even if equal efficacy by reduction of drug concentration is demonstrated, that does not mean that the limited potential side effects of prostanoids (hyperemia, irritation, change in iris color) are dose-dependent and will be decreased. Allergan's ill-advised manipulation of concentrations with their Alphagan (brimonidine) product by bringing out Alphagan-P did not take market share from its competitors within the glaucoma space.
