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 DEA is confusing the hoped-for-outcome .(retention of
 visual function) with the treatment needed to achieve that
 outcome (reduction of intraocular pressure)° While DEA concedes
 most glaucoma therapies became accepted through mclinical
 experiences _._64/ the Agency attempts to sustain its nnew#
 • ...... indication by pointing to the IND/NDA efficacy-based evaluation
 of timolol. Buts is timolol capable, in DEA_s languages of
 #sustain[ing] the lowered pressure and preserv[ing] visual
 function for the patlent s lifetime#?
 Government witness Keith Green testifies timoiol only
 helps 60% of_the patients who use it. 165/ Since.timoloi cannot
 achieve the perfection of result demanded by DEA's newly
 fabricated standard does DEA consider timolol to have no
 naccepted medicai use in treatmentS?
 .......
 No currently mappr0ved w glaucoma therapy tanpromise to
 nsustain the lowered pressure and prese_re visual function for
 164/ DEA Brief _ 70_ at 43:
 mother conventional glaucoma medications
 have proven their efficacy through years of
 clinical experience. The miotics,
 epinephrine compounds and carbonic anhydrase
 inhibitors have been proven effective in
 lowering intraocular pressure and preserving
 visual function.
 ___ a_, ACT Brief .at 133_135; Cross-examination of
 Dr. Richard North at 7_99 & 7-I00; Cross-examination of Dr. John
 Merritt at Tr° 10-125.
 Dr. Merritt directly challenges DEASs assertion that the
 miotics0 epinephrine and carbinoc anhydrase inhibitors have been
 subjected to efficacy tests to determine if they Wmaintain
 visual field° _ See Cross_examination of Dr. John Merritt at 10_lS°?o
 165/. Cross-examination of Keith Greens Ph.D° at 9_77o
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