BRIEFLY
- ALCON FILES NDA FOR NEW GLAUCOMA
TREATMENT, ANNOUNCES PRELIMINARY TRIAL RESULTS. Alcon has
announced that the FDA has accepted the filing of its new drug application
for a new glaucoma treatment, Travoprost 0.004% + Timolol
0.5% Fixed Combination (TTFC). The company also presented
preliminary six-week data from three of its ongoing Phase III clinical
trials on the drug at the recent Royal Hawaiian Eye Meeting. The data
from one of these studies demonstrated that TTFC reduced intraocular
pressure (IOP) by up to 12 mmHg. TTFC reduced IOP 2 mmHg more than
travoprost 0.004% alone at the 8:00 a.m. time point;
at the 10:00 a.m. and 4:00 p.m. time points, TTFC reduced IOP between
1 and 2 mmHg more than travoprost 0.004% alone. Alcon
also presented preliminary data from two other Phase III clinical
trials, which compared the IOP-lowering effect of TTFC to concomitant
therapy of travoprost 0.004% dosed in the evening plus
timolol 0.5% dosed in the morning. TTFC was not statistically
different from concomitant therapy at all the 8:00 a.m. time points
and at most, but not all, of the other measured time points. Data
from all three trials demonstrated that TTFC has a safety profile
comparable to the two single agents dosed concomitantly and that it
was safe and well tolerated in the patients who participated in the
trials.
- TOPCONS PATIENT-DRIVEN AUTOMATED
REFRACTOR APPROVED BY FDA. Topcon Medical Systems, Inc.
recently announced that its BV-1000 patient-driven automated refraction
system has received FDA Approval. The BV-1000 combines an objective
simultaneous binocular autorefractor, autokeratometer, automatic chart
projector and patient-driven vision tester in one instrument. An "intelligent"
software program guides the patient through the refraction process
with pre-selected voice prompts. The patient uses a joystick to respond
to the practitioner-selected sequence and completes the refraction
without the aid of a skilled technician. Clinical studies have validated
BV-1000 refraction results as repeatable and accurate. For more information,
call 800-223-1130 or go to www.topcon.com.
- MEDICARE AND MEDICAID SERVICES TO
REIMBURSE FOR OCCULT AND MINIMALLY CLASSIC AMD LESIONS.
QLT Inc. and Novartis Pharma AG recently learned that the Centers
for Medicare & Medicaid Services (CMS) will reimburse patients
treated with Visudyne for age-related macular degeneration (AMD) with
occult and minimally classic lesions that are four disc areas or less
in size and have evidence of recent disease progression. Until this
decision by CMS, Medicaid has only covered patients with classic age-related
macular degeneration. It will now also cover treatment for those with
the occult and minimally classic form of the disease, a leading cause
of blindness in people older than 50.
- STAAR SURGICAL UNCERTAIN ON LENS LAUNCH
DATE. Staar Surgical Co. is uncertain whether it can release
a new implantable contact lens by April as planned, because of problems
raised by federal regulators. Company officials met with the FDA last
week to discuss corrective action the FDA was taking after it issued
a warning letter to the company on December 29, 2003. The letter stated
that Staar had not developed adequate reporting procedures for injuries
related to the use of cartridges and injectors for foldable intraocular
lenses. It also required Staar to assure that test results on the
implantable lenses, as well as on the patented material used in the
lenses, were validated by an outside laboratory. Staar says it has
no indication when the FDA will respond to the corrective measures
it has taken in response to the warning letter but will issue a news
release when it receives a response. The company will not request
a re-audit by the FDA until it is certain that it has fully addressed
the concerns of regulators.
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