The UK’s Medicines and Healthcare Regulatory Agency has approved GenSight Biologics’ (EPA:SIGHT) application to combine gene therapy and a wearable optronic visual stimulation device in patients with retinitis pigmentosa.
The first-in-man Phase I/II trial is designed to study the safety and tolerability of GenSight’s GS030 combination therapy in three groups of three patients each.
GS030’s gene therapy component is administered via a single intravitreal injection. The trial’s primary outcome analysis will be the therapy’s safety and tolerability one year after the injection, the company reported. GenSight said it expects to treat the first patient in the study in the first quarter of 2018.
“I am particularly excited to have GS030 moving into the clinic. This represents a major milestone for the company,” co-founder & CEO Bernard Gilly said in prepared remarks.
“For the first time ever in ophthalmology, an optogenetic approach combined with a medical device will be tested in humans. If proven safe and effective, this therapy could be transferable from Retinitis Pigmentosa to dry-AMD.”
GenSight’s GS030 has orphan drug status in both the U.S. and Europe and the company reported that it intends to file additional IND and CTA submissions this year.