E DITORIALS
Modern Alchemy: Fixed Combinations of Glaucoma Drugs
L. JAY KATZ, MD
B
ARNEBEY AND ASSOCIATES
1
REPORTED A STUDY
that compared the efficacy and safety of travaprost
and timololcombined in onebottlewith the
efficacy and safety of the same medications when used
separately. This report reflects the current surge of interest
in partnering glaucoma medications in a single bottle.
In the medieval era,alchemists tried to make the rare
and precious metal gold by combining common elements
such aslead and sulfur. In somewhatsimilarfashion,
variousmixturesofcommonly used glaucoma drugs are
now combined into a single bottle in hopes that the
combined drop will work better than the individual com-
ponents alone.
This effort raises several questions:
1. Is there a need for fixed combinations of glaucoma
medications?
2. Which drugs are pharmacologically complementary
through different mechanisms of action and similar
dosing schedules?
3. Is the intraocular pressure (IOP)–lowering effect of
the fixed combinations sufficiently superior to that of
the individual drugs to justify the more frequent side
effects that will likely occur?
Recent randomized, prospective multicenter trials, such
as the Normal Tension Glaucoma Treatment Study, the
Collaborative Initial Glaucoma Treatment Study, and the
Ocular Hypertension Treatment Study, demonstrate that
to reach a desired target IOP, it is often necessary to use
multiple drugs.
2– 4
There have been a number of concerns
voiced abouthe useof multiplebottlesof glaucoma
medications: compliance, washout effect, preservative tox-
icity, and cost. Complex dosing regimens have been clearly
associated with nonadherence to medical therapy. Patients
who useonly one bottleare morelikely to use the
medication as ordered than if they are required to use two
or more bottles.
5
Furthermore, when more than one bottle
isused,patientsdo notalwaysallow adequate time for
ocularabsorption oftheir first medication before the
second drug is administered. Preservatives, specifically
benzalkonium chloride, are toxic to the eye in a variety
ways: conjunctival inflammation (possibly jeopardizing t
success of future glaucoma surgery), punctate keratopathy
and keratitis sicca, cataract progression, and cystoid mac-
ular edema after cataract surgery.
6 –10
When two individual
bottles are dispensed by certain formularies, the copaym
is likely to be morethan the copayment for a fixed
combination of the same two drugs. These concerns hav
spurred the search for glaucoma drugs that will work we
when put together in one bottle.
The only fixed-combination products approved by the
Federal Drug Administration for use in the United States
are epinephrine-pilocarpine and timolol-dorzolamide. Th
former combination is rarely used today, because neither
drug is particularly well tolerated, because epinephrine is
relatively ineffective in lowering IOP, and because the
ideal dosing regimen is different for the two medication
twice a day forepinephrine and four timesa day for
pilocarpine. Conversely, timolol-dorzolamide has attaine
widespread favor as a fixed-combination product. Both
timololand dorzolamide are effective when used twice
daily.Therefore, a twice-daily regimen with the fixed
combination of these two drugs provides maximal or ne
maximal efficacy.
11
The two drugsare additive in their
effect in lowering IOP, despite both being aqueous sup-
pressants.
At first blush, however, the ideal match would seem to
be -blockers and prostaglandin analogs; they are the tw
most effective drug classes in lowering IOP, they both a
used once a day, and theirmechanisms of action are
different, the -blockers suppressing the production of,
the prostaglandin analogs enhancing outflow of aqueous.
However, the studies of a fixed combination of timolol
with a prostaglandin analog have not yet yielded data
compelling enough to warrant the endorsement of the
Food and Drug Administration. The first reports investi-
gated the combination of timolol-latanoprost dosed onc
day in the morning. Higginbotham and associates pub-
lished their results after 1 year of therapy.
12
All patients
were initially placed on timolol and then placed in one o
three treatment arms:a fixed combination of timolol-
Accepted for publication Mar 10, 2005.
From the Glaucoma Service, Wills Eye Hospital, Philadelphia, Penn-
sylvania.
Inquiries to L. Jay Katz, MD, Glaucoma Service, Wills Eye Hospital,
840 Walnut Street, Philadelphia, PA 19107; fax: (215)928-0166; e-mail:
ljk22222@aol.com
©2005 BY E LSEVIER INC. ALL RIGHTS RESERVED . 0002-9394/05/$30.00 125
doi:10.1016/j.ajo.2005.03.034