First-to-Market Edge for Apellis’s Syfovre in Geographic Atrophy Diminished in the Face of an Unexpected Safety Signal

Exton, Pennsylvania, July 28, 2023 (GLOBE NEWSWIRE) — For many who have been following the retina market, the news about the emerging safety signal associated with Apellis’ Syfovre in geographic atrophy (GA) feels very similar to the dashed expectations following the short-lived excitement for Novartis’ Beovu launch, an event the community is still reeling from. As of Q2 2023, 71% of the 100 ophthalmologists surveyed in Spherix’s RealTime Dynamix™ Neovascular Age-Related Macular Degeneration (US) report agree that based on the post-marketing safety issues with Beovu, they are more cautious when adopting newly launched products in the retina space. Yet, until now, Syfovre has been a welcome addition given it is the only treatment available to help slow the progression of lesion growth due to GA, a condition that can ultimately lead to blindness. While Syfovre’s efficacy is perceived as marginal, it still provided some hope to patients that previously had none.

Unfortunately, now that hope is quickly fading. According to the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee, ophthalmologists have reported cases of intraocular inflammation (IOI) following the administration of Syfovre. In addition to mild-moderate IOI, these reports also include severe IOI, retinal vasculitis, and occlusive retina vasculitis (six cases at the time of writing). These events occurred between 7 and 13 days after the initial dose of Syfovre was administered. Apellis’s Medical Director, Caroline Baumal, issued a Dear Doctor Letter to the community shortly after ASRS provided the notification to prescribers. The Medical Director acknowledged the situation and assured ophthalmologists the FDA did not feel a label update was necessary at this time. Apellis’ outreach suggested there is suspicion that procedural changes between the clinical trials and real-world experience regarding injection techniques could have contributed to the increased incidence of IOI. As seen in the Beovu situation, Apellis, like Novartis, is working closely with the ReST Committee and several external specialists to continue to monitor the unfolding situation.

While the full impact of this event has yet to completely materialize, early signs suggest at least some damage may already be done. Spherix conducted a pulse study with 51 ophthalmologists within the days following the breaking news of the Syfovre safety signal and found that nearly all surveyed physicians reported at least a moderate impact on their future prescribing of Syfovre as a result of the reported IOI, with two-thirds suggesting the event will have a significant impact on future prescribing of the treatment. Furthermore, the vast majority also report their trust in Apellis has been at least moderately impacted. An unfortunate turn of events given that when surveyed in May through Spherix’s Launch Dynamix™ Syfovre in GA (US) service, only 10% of those polled reported being unlikely to recommend Syfovre to a colleague. Spherix will be monitoring this metric as the Syfovre launch continues to evolve.

Of particular note is the damage from the Syfovre post-marketing safety signal may expand beyond Apellis and Syfovre itself. During the recently conducted pulse study, Spherix also asked about the impact this event could potentially have on avacincaptad pegol (ACP), Iveric Bio’s (as of July 11^th, an Astellas company) developmental C5 inhibitor currently under FDA review with a PDUFA set for next month. Unfortunately for avacincaptad pegol, just over one-third of ophthalmologists report the signal seen with Syfovre is going to have a significant impact on future prescribing of ACP, while over half report it will have a moderate impact.

Whether or not ACP will feel the repercussions of the IOI seen with Syfovre is yet to be seen, but if FDA approved, Spherix will be tracking the launch of ACP through the Launch Dynamix™ service and will be assessing any collateral damage the brand may face in adoption from the recent Syfovre safety issues. Launch Dynamix™ coverage (for Syfovre and pending for ACP) consists of 18 monthly pulses and six quarterly deep dives (including qualitative interviews with ophthalmologists). Later in the year, Spherix will be publishing its inaugural RealWorld Dynamix™ Geographic Atrophy (US) study which will capture the total GA patient market, including candidates for and currently treated Syfovre and ACP patients, uncovering insights into the full patient potential of the market as well as the specific use patterns and characteristics of the two GA agents. 

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About Spherix Global Insights

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