02 March 2026
02 March 2026
IDE study results at 24 months showed an 87.1% composite clinical success rate with the Synergy Disc.
After three months, OPGx-BEST1 was well tolerated with no reports of observed ocular inflammation or adverse events.
The approval follows PEGASUS Phase III trial assessing Palynziq efficacy and safety compared to diet alone in adolescents with PKU.
The agreement includes Ipsen’s investment in additional equipment at Quotient Sciences’ facility in Boothwyn, Pennsylvania, US.
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