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EyeGate Pharma Initiates Phase III Study of EGP-437 in Patients With Anterior Uveitis


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EyeGate Pharma announced that it has enrolled the first patient in a milestone Phase III pivotal study of its lead product EGP-437 (a late-stage asset with multiple indications for inflammatory ocular indications), for the treatment of anterior uveitis. The company, a private specialty pharmaceutical company developing therapeutics designed to address two major issues in ophthalmic medicine, patient compliance and patient throughput, enrolled the patient at Tauber Eye Center in Kansas City, MO.

The randomized double-masked positive-controlled non-inferiority study will enroll up to 200 subjects at more than 20 US sites in order to assess the effectiveness of EGP-437 in comparison to topically applied prednisolone acetate eye drops. EGP-437 will be administered using the EyeGate® II Drug Delivery System, a non-invasive iontophoretic drug delivery technology.

Study investigator, Joseph Tauber, M.D., commented: "Our team is excited to have enrolled the first patient in this key study. This is a truly innovative approach that seeks to address the main issue of compliance by providing the doctor with direct control of the dosing. The Phase II data suggest that EGP-437, when delivered using the EyeGate® II Ocular Drug Delivery System, could lead to a more predictable clinical response and has the potential to improve the way anterior uveitis is treated."

"Based on the positive clinical results from the Phase II study, we are excited to initiate this Phase III study, which we believe will demonstrate significant treatment benefits over traditional treatments with prednisolone acetate. We remain committed to eliminating the major issue of compliance that corneal specialists and their patients struggle with when treating serious inflammatory episodes," said Stephen From, President and CEO of EyeGate Pharma.

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