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FDA OKs trials for Isotechnika eye drug

Isotechnika has said that its lead immunosuppressive drug ISA247 for eye disease is positioned to enter phase II/ III trials by its partner Lux Biosciences after clearance of its investigational new drug application by the FDA.

ISA247, which is referred to as LX211 by Lux, will be investigated in the oral capsule formulation for the treatment of active and control of uveitis, an autoimmune disease resulting in chronic inflammation of the eye.

Earlier this year, Isotechnika signed an agreement with Lux Biosciences granting Lux worldwide rights to develop and commercialize Isotechnika's lead drug, ISA247 for the treatment and prophylaxis of all ophthalmic diseases.

“With preparations well under way, we look forward to enrolling our first patient into the pivotal studies by early January of next year. We believe that our next generation calcineurin inhibitor LX211 has great potential in uveitis; a well-studied and approved medication other than steroids would be enormously beneficial for patients who suffer from this debilitating disease,” commented Ulrich Grau, president & CEO of Lux Biosciences.

“We remain committed to advancing ISA247 in multiple indications to increase shareholder value and provide more effective treatments to kidney transplant patients and to those who suffer from psoriasis and uveitis,” stated Dr Randall Yatscoff, Isotechnika's president and CEO.