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	AUTH/2389/2/11
Parties	Allergan v Alcon Laboratories (UK) Limited
Product	Travatan (travaprost preserved with Polyquad)
Material	Advertisement (ref TBF:AD:12/10:LHC) in the British Journal of Ophthalmology; campaign visual of a thornless rose
Main issue	Implied improved tolerability/safety vs BAK-preserved formulation based on visual metaphor and animal/in vitro data, despite clinical evidence indicating similar safety profiles
Applicable Code year	2008
Complaint received	21 February 2011
Case completed	09 June 2011
Appeal	Appeal by respondent; rulings upheld
Breach clauses	7.2 (x2), 7.3 (x2), 7.10 (x2) and 9.1
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Allergan complained about an Alcon 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…” vs BAK-preserved latanoprost solutions in vitro).
Allergan alleged the visual and claims implied improved ocular tolerability/safety vs the prior BAK-preserved Travatan formulation, without supporting clinical evidence (citing Denis et al 2010, which found similar safety profiles).
Allergan also alleged “BAK-free” implied preservative-free; Alcon argued the ad clearly stated “A multidose prostaglandin analogue with POLYQUAD”.
Alcon appealed the Panel’s breach findings; the Appeal Board reviewed the wording and the cited evidence.

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Breach found (upheld on appeal): The thornless rose visual was misleading and exaggerated the difference between Travatan preserved with Polyquad and Travatan preserved with BAK.
Breach found (upheld on appeal): The use of animal and in vitro data in the ad implied better tolerability/safety vs BAK-preserved Travatan, which was not supported by the available clinical data (Denis et al).
No breach: “BAK-free” did not imply preservative-free (the ad stated it was “with POLYQUAD”).
No breach: The Panel did not accept that the thornless rose implied a complete lack of side-effects.
No breach: The Panel did not accept that the visual implied a comparison with competitor products.
Breach found (upheld on appeal): High standards had not been maintained.

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