Apellis Pharmaceuticals Inc (NASDAQ:APLS) jumped some 35% in Wednesday’s deals after last night updating investors on an ongoing safety review of injection kits used with SYFOVRE, the company's treatment for eye disease.
A review was previously launched after reports of rare side effects - a form of eye inflammation known as retinal vasculitis.
The market evidently has taken the update as good news, though the process is continuing.
In a statement, the company said that more than 100,000 vials have been distributed between real-world and clinical trials, and since its prior stock market update, one additional case of retinal vasculitis had been identified.
Eight events of retinal vasculitis have been confirmed in total, the company said, and all were observed after the first injection of SYFOVRE.
It noted that one affected patient had recovered vision to baseline, two recovered "nearly to baseline", and two have had severe impairments which are unlikely to be resolved. Three patient outcomes are still pending, it added.
Apellis additionally told investors that, as part of the review, issues had been identified regarding the use of 19-gauge filter needles in certain injection kits, and that the company recommends the use of 18-gauge filter needles.
“Based on the findings from our investigation, we believe it is prudent that practitioners only use the kits with the 18-gauge filter needle, which are already in distribution,” Apellis chief medical officer Caroline Baumal said in a statement.
“This recommendation is out of an abundance of caution as patient safety is our top priority.”
The company did, however, note that a causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis in the real world.
In New York, Apellis stock was up US$10.84 or 36%, changing hands at US$41.80 per share.