Eye­Gate surges on FDA nod to start piv­otal study; Alde­vron to build gene ther­a­py man­u­fac­tur­ing cam­pus in Far­go, N.D.

→ Eye­Gate — a phar­ma­ceu­ti­cal com­pa­ny spe­cial­iz­ing in de­vel­op­ing treat­ments for dis­eases and dis­or­ders of the eye — an­nounced the FDA’s ap­proval to ini­ti­ate its pho­tore­frac­tive ker­a­te­c­to­my (PRK) piv­otal study. The FDA has asked for mod­i­fi­ca­tions to be made to the pa­tient in­formed con­sent doc­u­ment pri­or to pa­tient en­roll­ment in the study and the com­pa­ny says that it will ad­dress these mod­i­fi­ca­tions im­me­di­ate­ly and ex­pects en­roll­ment to be­gin next month.

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