AUTH/2389/2/11: Allergan v Alcon — Travatan “thornless rose” visual and lab-data tolerability claims | PMCPA Case

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Key facts

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Case number	AUTH/2389/2/11
Parties	Allergan v Alcon Laboratories (UK) Limited
Product	Travatan (travaprost preserved with Polyquad)
Medium	Journal advertisement (British Journal of Ophthalmology); campaign visual
Key creative	Thornless rose with 13 thorns at the base
Main issue	Implied improved tolerability/safety vs BAK-preserved formulation based on visual and non-clinical data
Clinical comparator cited	Denis et al 2010 (noted as the only direct clinical comparison; concluded similar safety profiles)
Applicable Code year	2008
Breach clauses	7.2 (x2), 7.3 (x2), 7.10 (x2) and 9.1
Complaint received	21 February 2011
Case completed	09 June 2011
Appeal	Appeal by respondent; key breach rulings upheld
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Allergan complained about Alcon’s promotional campaign for Travatan (travaprost preserved with Polyquad) featuring a thornless rose with 13 thorns at the base, used in an advertisement in the British Journal of Ophthalmology.
The headline read “Introducing BAK-free formulation Travatan”, and the ad included claims based on animal and in vitro studies (eg “gentler effect on the ocular surface than BAK in laboratory studies” and “Significantly less toxic…”).
Allergan alleged the visual and claims implied an improved ocular safety/tolerability profile versus the prior BAK-preserved Travatan formulation, without supporting clinical evidence (citing Denis et al 2010 as showing similar safety profiles).
Allergan also alleged “BAK-free” implied “preservative-free” (despite Polyquad being present) and raised a high standards concern.
Alcon argued the visual simply communicated removal of BAK (not “side-effect free”), that Polyquad was clearly stated, and that animal/in vitro models were relevant and commonly used in the field.

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Breach found: The thornless rose visual was held to be misleading and to exaggerate the difference between Travatan preserved with Polyquad and Travatan preserved with BAK.
Breach found: The animal and in vitro data/claims were held to imply better tolerability/safety versus BAK-preserved Travatan, which was not supported by the available clinical evidence (Denis et al concluded similar safety profiles).
No breach: “BAK-free” was not found to imply “preservative-free” because the ad stated “A multidose prostaglandin analogue with POLYQUAD”.
No breach: The Panel did not find the visual implied a comparison with competitor products.
Breach found: High standards had not been maintained.
Alcon appealed; the Appeal Board upheld the key breach rulings (including that “Significantly less toxic…” did not reflect the cited paper’s more qualified wording and that clinical effects should not be inferred from non-clinical studies without clinical evidence).

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