info@apellis.com
100 5th Avenue
Waltham, MA 02451
October 10th, 2023
To the Retina Community,
As part of our commitment to keep you informed, we are writing to provide a SYFOVRE update on long-term and real-world safety and how cases are evaluated and reported.
On October 5, we announced that more than 100,000 commercial and sample vials have been shipped to physician practices since FDA approval, with approximately 37,000 commercial vials and 10,000 samples distributed in the third quarter.
Long-term and real-world safety
- In the GALE study at 30 Months, the safety profile of SYFOVRE continued to be consistent with previously reported Phase 3 data. There were no cases of vasculitis identified in any of the SYFOVRE clinical trials, representing more than 24,000 injections to date.
- The estimated real-world rate of retinal vasculitis remains rare, at 0.01% per injection.
- In total, there have been 10 confirmed events of retinal vasculitis (seven occlusive, three non-occlusive) and two suspected events.
- Since the last update on August 22, 2023, there was one new confirmed event that occurred in early August and two new suspected events, one that occurred in mid-August and one in September. Of the two events that were previously classified as suspected, one event has been confirmed and the other was adjudicated to not be retinal vasculitis.
- Of the confirmed retinal vasculitis events, six patients have recovered vision either fully or partially, three patients have severe vision impairment that is unlikely to be resolved, and one patient’s outcome is pending. Visual outcomes in both suspected events are pending.
How are cases evaluated and reported
As shared with Retina Today, Drug Safety and Pharmacovigilance is an integral part of Apellis’ process and culture, safeguarding patient safety at all times. Apellis’ Safety & Medical Team reviews all post-market events reported with SYFOVRE. Any new suspected events of IOI, including retinal vasculitis, are systematically assessed and adjudicated based on all available information. Where information is missing, targeted follow-up (i.e., specific questionnaire, collection of imaging) is performed by internal Apellis team members. Requested data includes baseline patient characteristics, imaging (angiography, OCT, fundus photography) and long-term visual outcomes. All suspected retinal vasculitis cases are also independently evaluated and adjudicated by two external sources: a panel of four retina and uveitis experts, and an independent reading center, Digital Angiography Reading Center (DARC).
Apellis submits all reported adverse events to the FDA and other applicable Regulatory Agencies consistent with reporting guidelines and regulations for drug manufacturers. Apellis and the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee are in close communication regarding reported cases of retinal vasculitis following SYFOVRE treatment. While the adjudication of vasculitis may differ between ASRS and Apellis, the visual outcomes are most important, and are monitored closely by both parties.
Patient safety is our top priority. We are committed to making a meaningful difference in the lives of people impacted by geographic atrophy and will continue to provide you with the information you need to make the best treatment decisions for patients.
Best,
Caroline Baumal, MD
Chief Medical Officer
Tuan Dong Si, MD
Senior Vice President, Global Drug Safety & Pharmacovigilance