Regulatory American Society of Retinal Specialists raise concerns regarding Apellis...

American Society of Retinal Specialists raise concerns regarding Apellis Pharmaceuticals’ Syfovre

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The American Society of Retinal Specialists (ASRS) issued a letter to doctors raising concerns over the use of Apellis Pharmaceuticals’ Syfovre, as the drug may have been responsible for causing eye inflammation in patients treated with it.

The safety committee advising the group cited six cases in which patients developed occlusive retinal vasculitis after using the drug. Symptoms started appearing within a couple of weeks of the first Syfovre injection being administered.

Occlusive retinal vasculitis is a type of eye inflammation in which blood flow to the vessels going up to the retina is blocked and can lead to complete blindness.

After close follow-ups and vigilance by the organization, the hiccup could not be tied to any specific batch of the drug, and the cause for the disease remains unknown as well.

Analysts Umer Raffat and Jon Miller of Evercore ISI have also pointed out that there is no agreement on all six instances of retinal vasculitis, nor have the findings of the committee been peer-reviewed yet.

Among all the six patients, only one is suffering from significant loss of vision, while in the case of the other five patients, no major outcomes have been reported.

Despite the fact that the real-world safety profile of the drug has been in line with the results of its clinical trials, this news breaking has caused stock prices for the company to sink. In phase 3 trials for the drug, no occurrences of retinal vasculitis were observed, and the rate of real-world occurrences of the condition was 0.01% per injection.

At the opening of this week’s trading, shares lost one-fifth of their value, and stock prices sunk by over 30% to $52.62 by day end.

In the past, though the drug was able to surpass the expectations of Wall Street analysts in terms of commercial expectations, and at one point, Evaluate Pharma predicted that the drug would be able to reach sales of over $2.6 billion by 2028.

About the situation, an Apellis Pharmaceuticals representative said, “We are in the process of thoroughly investigating all cases with external experts, including real-world procedure techniques and potential risk factors. Patient safety is our top priority, and we take any adverse event seriously.”

Syfovre was the first drug to gain FDA approval to treat geographic atrophy this February and is administered to patients every 25 to 60 days. Since the approval, about 60,000 vials of Syfovre have been delivered to the country.

The approval is considered the culmination of 4 years of hard work by co-founder and CEO Cedric Francois.

Many other organizations like Apellis have tried and failed in this field in the past. ASRS had flagged Novartis’ wet age-related macular degeneration drug Beovu in 2020 after 14 cases of retinal vasculitis were found in patients being treated with the drug.

In the case of Novartis too, the news caused the shares of the company to decline by 5.5%, and in one instance, a doctor stopped prescribing the medication after hearing the news.

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