ASRS 2023 – Syfovre’s side-effect questions still loom large

Earlier this month, a report of six cases of severe eye inflammation following real-world use of Apellis’s geographic atrophy drug Syfovre crashed the company’s stock. On Saturday, the American Society of Retina Specialists' conference heard details on these and several more cases of retinal vasculitis, which can lead to blindness. Cowen analysts described the uptick in numbers as “disappointing” but added: “We believe it is a smaller number of cases than many investors had feared.” And the rate of these adverse events does not look as bad as with Beovu, the Novartis wet AMD drug for which sales expectations were sliced on toxicity fears. However, the cause of retinal vasculitis in the Syfovre-treated patients is still unknown, and it is also unclear how the side-effect worries might affect the drug’s launch, which has so far been strong. Apellis reported second-quarter product sales of $67.3m today, beating expectations of around $40m, but these were booked before the latest developments. Apellis’s share price fell 9% this morning, suggesting investors are yet to be convinced. Syfovre could soon be facing competition in geographic atrophy: Iveric’s avacincaptad pegol, now in the hands of Astellas, is due an FDA approval decision by August 19.

Reported cases of retinal vasculitis with Apellis's Syfovre
  Number of cases
  Occlusive Non-occlusive
ASRS ReST Committee notification 15 Jul 2023 6 -
Apellis update 29 Jul 2023 4* 3*
ASRS ReST Committee update 29 Jul 2023 8** 3^
*Confirmed cases only; **includes 1 unconfirmed case; ^includes 2 unconfirmed cases; ReST=Research and Safety in Therapeutics Committee. Source: ASRS & company statements.

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