Apellis Pharmaceuticals, Inc. presented 3-year data from the phase 3 GALE extension study on Syfovre (pegcetacoplan injection) 15 mg/0.1 mL for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
First, a rundown on Syfovre.
The FDA approved Syfovre for commercial distribution in February 2023—which was, at the time, the first and only approved therapy for GA for use beyond 12 months (click here for some background, including a visual on how it works).
The formulation was designed as a 15 mg/0.1 mL dose to be administered by intravitreal injection once every 25 to 60 days into each affected eye to potentially reduce the progression of GA.
Didn’t we just hear about new data on this?
Yes we did! In fact, just last month The Lancet published 24-month results from the OAKS (NCT03525613) and DERBY(NCT03525600) phase 3 trials.
The findings: both every-other-month (EOM) and monthly dosing of Syfovre illustrated a clinically meaningful reduction of GA lesion growth with increasing effects over time as well as a favorable safety profile.
Click here to read more.
And this new data?
Presented by Jeffrey S. Heier, MD, director, retina service and director, retinal research, Ophthalmic Consultants of Boston, the data found that Syfovre continued to demonstrate increasing treatment effects over time.
Give me some numbers, please.
Per Apellis, at Year 3, Syfovre:
- Reduced GA lesion growth with both monthly (35%; p<0.0001) and EOM (24%; p<0.0001) treatment compared to the projected sham arm.
- Reduced nonsubfoveal GA lesion growth with both monthly (42%; p<0.0001) and EOM (28%; p=0.0015) treatment compared to the projected sham arm.
- Reduced GA lesion growth by 19% (p<0.0001) after one year of SYFOVRE treatment (combined monthly and EOM), compared to the sham treatment period, in patients who crossed over from the sham group.
To note: all p-values were nominal.
Expert input?
Per Dr. Heier: “These 3-year data further solidify the long-term durability of both every-other-month and monthly Syfovre, including the increasing treatment effects over time.”
And according to Apellis CMO Caroline Baumal, MD, Syfovre has demonstrated increasing treatment effects year-over-year, with “a more than 40% reduction in nonsubfoveal lesion growth in the third year,” she stated.
The American Academy of Ophthalmology annual meeting is being held Nov. 3-6 2023, in San Francisco, California.