Apellis Presents Phase 3 Functional Analyses of SYFOVRE™ (pegcetacoplan injection) for Geographic Atrophy

• Showed visual function and quality-of-life benefits in patients with extrafoveal lesions
• Slowed the loss of retinal pigmented epithelial and photoreceptor cells, both of which are required for visual function
• Eight abstracts, including three oral presentations, highlighted at ARVO annual meeting

WALTHAM, Mass., April 23, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced post hoc analyses from the 24-month, Phase 3 OAKS and DERBY studies evaluating SYFOVRE™ (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The analyses were reported during oral presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting taking place April 23-27 in New Orleans.

SYFOVRE showed visual function and quality-of-life benefits in patients with extrafoveal lesions (≥0.25 mm from the foveal center). Additionally, SYFOVRE showed a meaningful reduction in the loss of photoreceptor and retinal pigmented epithelial (RPE) cells, which are both required for vision. These analyses utilized data from patients with SPECTRALIS® optical coherence tomography (OCT) images, which allowed for artificial intelligence (AI)-based automated segmentation of the photoreceptor and RPE layers as well as determination of the amount of the central foveal region covered by the GA lesion (foveal occupancy).

SYFOVRE showed visual function and quality-of-life benefits in patients with extrafoveal lesions

In the 24-month analysis, SYFOVRE-treated patients compared to sham demonstrated:

• Preservation of 5.6 letters, equivalent to more than one line of vision on an ETDRS chart, as measured by best corrected visual acuity (BCVA).
• A 4.1-point benefit in vision-related quality-of-life outcomes, as measured by the NEI-VFQ-25. The questionnaire assesses outcomes, such as social function, driving, and dependency on others. Four points is considered clinically meaningful.1

“Vision loss caused by GA can profoundly impact a person’s independence and well-being, so it is vital that SYFOVRE has shown slower vision loss and better quality of life compared to sham in this post hoc analysis. These data also support earlier treatment with SYFOVRE,” said Allen Chiang, M.D., presenting author and associate professor of ophthalmology at Wills Eye Hospital, Mid Atlantic Retina, and Thomas Jefferson University. “As the first and only approved medicine for GA, SYFOVRE represents a new treatment era for this devastating disease.”

Due to sample size considerations, every-other-month and monthly data from OAKS and DERBY were combined for the SYFOVRE (n=131) and sham (n=61) groups. These data are in addition to the functional benefit outcomes previously reported in the post hoc junctional zone microperimetry analysis.

SYFOVRE slowed photoreceptor and RPE cell loss compared to sham

In the 24-month analysis of OAKS (n=456) and DERBY (n=435), SYFOVRE demonstrated a meaningful reduction in the loss of both photoreceptor and RPE cells compared to sham (all p-values nominal):

• Photoreceptor cells
  • Every-other-month: 46% (OAKS; p