South San Francisco, CA — November 9th, 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 one year (48 weeks). The safety profile was in line with previous lampalizumab trials. Based on the totality of data from Chroma and Spectri, Genentech will not pursue approval from the U.S. Food and Drug Administration (FDA) for lampalizumab in geographic atrophy.
Spectri (GX29185; NCT02247531)1 and Chroma (GX29176; NCT02247479)2 were identically-designed, double-masked, randomized, global Phase III studies evaluating the efficacy and safety of a 10 mg dose of lampalizumab administered every four or six weeks by intravitreal injection, versus sham.
Genentech 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 analyzing 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, November 10th3
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. 2017. Lampalizumab Phase III Trial for Geographic Atrophy Secondary to AMD; the Spectri Top Line results. Presented at American Academy of Ophthalmology Annual Meeting, New Orleans, LA, USA.
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.