Statements

Statement on Chroma Study

November 10, 2017

Chroma, the second of two phase III studies evaluating the safety and efficacy of lampalizumab, an investigational medicine for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), did not meet its primary endpoint. Consistent with data from Spectri, the first phase III study reported in September 2017, lampalizumab did not reduce mean change in GA lesion area compared to sham treatment at 1 year (48 weeks). The safety profile was in line with previous lampalizumab trials. Based on the totality of data from Chroma and Spectri, Roche will not pursue marketing approval for lampalizumab in geographic atrophy.

Spectri (GX29185; NCT02247531)1 and Chroma (GX29176; NCT02247479)2 were identically-designed, double-masked, randomised, global phase III studies evaluating the efficacy and safety of a 10 mg dose of lampalizumab administered every 4 or 6 weeks by intravitreal injection, versus sham.

Roche remains committed to developing effective and innovative medicines for patients with serious, vision-threatening eye diseases. We would like to thank the investigator community and study participants for their generous support in both trials. We are committed to further analysing these data and sharing our learnings with the scientific community to advance the understanding of geographic atrophy. Spectri data will be presented as a late-breaker oral presentation during the American Academy of Ophthalmology (AAO) 2017 Retina Subspecialty Day, Friday 10th November.3 Data from both studies will be presented at upcoming medical meetings.

  1. ClinicalTrials.gov. Spectri lampalizumab study page. https://clinicaltrials.gov/ct2/show/NCT02247531. Accessed 4 September 2017.
  2. ClinicalTrials.gov. Chroma lampalizumab study page. https://clinicaltrials.gov/ct2/show/NCT02247479. Accessed 4 September 2017.
  3. Heier, JS. Lampalizumab Phase III Trial for Geographic Atrophy Secondary to AMD; the Spectri Top Line results. Presented at the 2017 American Academy of Ophthalmology Annual Meeting, New Orleans, LA, USA.