vol1 - Page 365

 the patient's lifetime. _ Nonetheless__
 DEA insists that
 retention of visual function, the Agency's nnew# standards is
 viable. DEA explains:
 When new glaucoma treatments are tested for
 [an NDA determination of] efficacy0 they are
 evaluated for their ability to sufficiently
 lower intraocular pressures an4____9_.___D__i_
 visual field_. To properly measure the
 treatmentSs effect on both_ it must be use@
 in long?term testing. _T_molcl _ _ . has been
 tested in this manner. 166/ (_mphasis added)°
 Aside from a handful of statements by DEA witness
 Green, there is no evidence to suggest timolol'soNDA approval was
 based on any scientificdemonstration timolol _retained visual
 field° #-16[/ DEA seeks to support its position by citing
 testimony from Alliance witness_ Dr° Jo_ Merritt. In the
 testimony DEA references, however, Dro Merritt makes precisely
 the opposite point.
 It]he statement that Timolol alters the
 visual fields in a positive sense has
 definitely not been shown in _e published
 data to date .... [FDA_ only looked at
 pressure  ffects [in its NDA review
 of timolol]. _-_'
 i-_/ DEA Brieft _ 70_ at 42 (emphasis added).
 I_// Cross-examination of Keith Greene Ph.D. Tr. 9_74 & 9-75.
 Green testifies he thinks visual field analysis was critical to
 the NDA approval of timolol, an IOP lowering agent_ Signifi-
 cantly, Green later prefaces his testimony on timolol by noting
 he is recollecting _to the best of my knowledge, u /__. at Tr. 9 -
 74 & 9-75_ Tr. 9_178. The limits to GreenSs knowledge are
 quickly reached when he cannot identify a single timolol study
 which demonstrates his claim timoloi _retains visual function, n
 _. at Tr. 9-75° _ alsq ACT Brief at 176-178o
 ii_/ Cross-examination of Dr. John Merritt at Tr° 10-187 & i0 _
 188. Dr. Merritt also addressed this point on cross-examination
 by DEA at Tr. I0-231_ #Timolol [approval] was based onlyoon
 [evidence of the drug's] pressure lowering effect only. _
 59 -