PRESS RELEASE Alexandria, Va Click to read more about the treatment ., Aug. 27, 2015 —The Academy of Managed Treatment Pharmacy is disappointed in the Food and Drug Administration’s draft assistance and proposed guideline that demands biologics, including reference products and biosimilars, to bear a non-proprietary name with an FDA-designated suffix. For several years, AMCP has been seeking a decision from the FDA on the naming concern and recently joined 18 diverse healthcare stakeholders urging the agency to utilize the same nonproprietary titles for both biologics and biosimilars. Based on the FDA assistance and proposed rule, both issued Aug.
For this pharmacogenetic substudy, 834 of 1149 trial individuals had been genotyped for four single nucleotide polymorphisms known to be associated with AMD susceptibility: rs1061170 in the CFH gene, rs10490924 in ARMS2, rs11200638 in HTRA1, and rs2230199 in C3. Stephanie Hagstrom and co-workers looked for correlations between genotypic frequencies and clinical methods of response to therapy at 1 year. There were three visual outcome steps: mean VA, mean modification in VA, and the proportion of individuals with a 15-letter or more increase in VA. In addition, five anatomic outcome measures had been evaluated: retinal thickness, mean change in total foveal thickness, presence of fluid on optical coherence tomography, existence of leakage on fluorescein angiography, and mean transformation in lesion size.