BRIEFLY
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FDA
GIVES PRE-MARKET APPROVAL TO PHAKIC IOL. Ophtec USA, Inc.,
a privately held medical device manufacturer and subsidiary of Ophtec
B.V. (Netherlands), and Advanced Medical Optics, Inc. (AMO), have
received FDA pre-market approval (PMA) and expedited review status
for the Artisan/Verisyse phakic IOL. Ophtec will continue to market
the product under the trade name Artisan, while AMO, the exclusive
distributor for the product in North America and Japan, will market
the product under the name Verisyse, which it has done in Europe since
2002. The PMA covers the correction of myopia in phakic eyes in the
range of -5.00D to -20.00D. The Artisan/Verisyse phakic IOL is the
first of several planned product offerings that will include indications
for treating hyperopia, astigmatism and cataracts; it has already
been approved for these uses in Europe.
- POSITIVE DATA FROM PHASE Ib/II STUDY
OF AMD DRUG. Genentech has announced promising preliminary
data from the extension phase of an open-label Phase Ib/II study of
Lucentis (ranibizumab). Lucentis, formerly known as rhuFab V2, is
an investigational anti-angiogenesis drug for treating patients with
wet age-related macular degeneration (AMD). The single-agent, multi-center
trial had a first treatment period of 98 days, during which 64 patients
with minimally classic and predominantly classic wet AMD were treated
every four weeks for four doses (either 300 or 500 mcg) of Lucentis
(53 patients) or with usual care of observation or photodynamic therapy
(11 patients). After Day 98, patients in the usual care group were
permitted to cross over to receive Lucentis. Forty-two of the 53 patients
who received Lucentis during the first treatment period continued
with the drug for the second treatment period; 40 completed the study
to Day 210. VA at Day 98 in patients who continued with treatment
improved by an average of 7.4 letters (20 patients) in the 300 mcg
group and 12.6 letters (22 patients) in the 500 mcg group. At Day
210, their VA improved further to an average gain of 12.8 letters
(19 patients) in the 300 mcg group and 15.0 letters (21 patients)
in the 500 mcg group compared with the baseline. Patients receiving
usual care had an average loss in VA of 5.1 letters (11 patients)
at Day 98, but those who crossed over to Lucentis improved on the
average by 7.3 letters (4 patients) and 3.2 letters (5 patients) at
completion, compared with baseline in the 300 and 500 mcg groups,
respectively. Thirty-nine of the 40 patients (97.5 percent) who were
treated with Lucentis for six months and completed the study through
Day 210 had stable or improved vision at completion. Adverse events
were similar in both treatment periods, including three serious adverse
events of endophthalmitis, recurrent uveitis and central retinal vein
occlusion. All were successfully treated or resolved. Genentech is
currently enrolling patients into two Phase III clinical trials for
Lucentis: one to evaluate the safety and efficacy of two different
doses in minimally classic or occult wet AMD patients, and the other
to compare two different doses of Lucentis with verteporfin photodynamic
therapy in patients with predominantly classic wet AMD. For more information
on these trials, call 888-662-6728.
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CORNEAL TOPOGRAPHERS UPGRADED.
Paradigm Medical Industries, Inc. recently announced major upgrades
of its Dicon CT 200 and CT 50 Corneal Topographer products. The enhancements
incorporate advances in the Windows operating system and computing
platforms. The improved CT200 Topographer features an optimized processor,
more RAM, a larger and faster hard drive and an LCD display. For more
information, call 801-977-8970 or go to www.paradigm-medical.com/pages/eq_ct200.html.
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