AUTH/2289/12/09: Merck Sharp & Dohme v Alcon — Azarga “comfort” leavepiece and over-emphasis claims | PMCPA Case

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Key facts

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Case number	AUTH/2289/12/09
Parties	Merck Sharp & Dohme v Alcon Laboratories (UK) Limited
Material	Eight-page A5 leavepiece for Azarga, ref AZG:SJ:12/08:LHC, titled “Find comfort in our strength”
Medicine	Azarga (brinzolamide/timolol eye drops)
Comparator mentioned	Cosopt (dorzolamide/timolol)
Main issue	Repeated absolute “comfort/comfortable” messaging creating a misleading, exaggerated overall impression
Complaint received	17 December 2009
Case completed	12 May 2010
Applicable Code year	2008
Breach clauses (final)	Clause 7.2 and Clause 7.10
Sanctions	Undertaking received; Additional sanctions: Not stated

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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Merck Sharp & Dohme complained about an eight-page A5 leavepiece for Azarga (brinzolamide/timolol eye drops) issued by Alcon Laboratories (UK) Limited (ref AZG:SJ:12/08:LHC), titled “Find comfort in our strength”.
The leavepiece heavily featured “comfort” messaging (complainant alleged 13 comfort/comfortable claims across 8 pages), including straplines such as “Where strength meets comfort”.
A key comparative claim appeared above a bar chart using Vold et al data: “Significantly more comfortable than Cosopt Solution”, alongside a chart titled “Patients Reported Greater Discomfort with Cosopt than with Azarga Suspension”.
MSD alleged the comfort positioning was not consistent with the Azarga SPC and not supported by evidence; it also argued the material implied longer-lasting discomfort by not stating studies measured transient post-instillation discomfort, and that the focus on comfort did not fairly reflect other tolerability information (eg blurred vision).
Alcon argued comfort/discomfort are interchangeable in ophthalmology; the comparative claim was supported by Vold et al (and supported by Mundorf et al and Manni et al), and the specialist audience would understand “comfort” without a definition.

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Comparative claim upheld on appeal (no breach): The Appeal Board ruled no breach for “Significantly more comfortable than Cosopt Solution” (Clauses 7.2, 7.4, 7.10) because it was not inconsistent with Vold et al or the Azarga SPC and was capable of substantiation when presented with the supporting bar chart data.
Repeated absolute “comfort” messaging breached: The Appeal Board upheld the Panel’s ruling that the cumulative repeated use of “comfort/comfortable” as absolutes was exaggerated, all-embracing and misleading, implying no discomfort with Azarga when many patients reported some discomfort.
Transient discomfort point: No breach was ruled for the allegation that failing to state the studies measured transient post-instillation discomfort implied longer-lasting discomfort.
Definition of “comfort” point: On appeal, the Appeal Board ruled no breach for not defining “comfort” in the leavepiece, given the intended audience (ophthalmologists) would understand the term in context.
Blurred vision omission: No breach was ruled for not referring to blurred vision in the context of a discussion about discomfort.

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