Industry News
Industry News
Recent developments in the vision care industry
FDA running low on funds?
The director of the US FDA Andrew von
Eschenbach found himself squeezed between
the president that hired him and the
congress that provides funding for his
organisation as he lobbied for an extra
$275m to monitor imported drugs and to
improve regulation and surveillance of drugs
and medical devices in the US. Dr von
Eschenbach appeared to act on his own
initiative, citing a need for more international
offices and for better monitoring of drug
hazards in the US.The FDA has faced
considerable criticism in the face of a number
of recent scandals involving tainted food and
drugs.The director’s budget request was over
and above the $50.7m increase over the
prior year for a total of $1.77bn requested
by the Bush administration. It is virtually
unheard of for a presidential appointee to go
beyond spending plans advocated by the
White House.
www.fda.gov
Reichert approval
Reichert received 510(k) clearance from the
US FDA to market its spectral optical
coherence tomography system, Optopol
SOCT Copernicus.The system produces
high-resolution, three-dimensional images of
the retina.
www.reichert.com
Diclofenac solution
Akorn has received FDA approval of its
abbreviated new drug applications for 0.1 per
cent diclofenac sodium ophthalmic solution
as well as 0.3 per cent ofloxacin ophthalmic
solution.The company expects to launch
diclofenac in the second quarter of this year.
The company said it plans to launch its
ofloxacin product in the third quarter of this
year.
www.akorn.com
Research Updates
Regulatory Updates
Faster femtosecond laser approved
AMO has announced it has received approval
to market the iFS™ Advanced Femtosecond
Laser.The fifth-generation IntraLase
femtosecond laser can create a LASIK flap in
less than 10 seconds. Its features include an
inverted bevel-in side cut angle designed to
provide easier flap lifting while enhancing the
biomechanical stability of the post-LASIK
cornea. It can also be used to produce an
elliptical flap to enhance keratoplasty
procedures.The new laser has a higher
repetition rate, tighter spot separation and
lower energy requirements than previous
models.
www.intralase.com
Special status for Staar aspheric IOL
The US Centers for Medicare and Medicaid
Services has classified Staar’s Afinity Collamer
Aspheric foldable intraocular lens CQ2015A
as a New Technology Intraocular Lens
(NTIOL).This designation increases the
reimbursement from Medicare, which pays
for a majority of cataract procedures in that
country.After a few rough quarters there are
signs the company may be moving to more
solid financial ground.The company reported
20 per cent sales growth in total US sales,
including sales of the Visian ICL phakic lens.
International sales were up 37 per cent over
the year before. www.staar.com
Bausch enters iontophoresis arena
Bausch & Lomb, in conjunction with EyeGate
Pharma, announced the start of a Phase I
clinical study to assess the safety and
tolerability of the non-invasive EyeGate II
Ocular Drug Delivery System.The system
works through iontophoresis, in which
medication is delivered transdermally when
an applied electric field enhances the mobility
of molecules through cells and tissues.The
randomised, single-masked, comparativegroup study is designed to establish the
maximum tolerated current that can be
employed during iontophoretic treatment
with the system.The company hopes to
initiate clinical trials for treatment of severe
uveitis and dry eye.
www.bausch.com
Wet AMD trial expands
NeoVista got the regulatory green light to
expand the number of sites participating in
its Phase III trial of brachytherapy for treating
wet AMD from 10 to 30.The CNV
Secondary to AMD Treated with Beta
Radiation Epiretinal Therapy (CABERNET)
trial seeks to evaluate the safety and efficacy
of NeoVista's novel epiretinal brachytherapy
for wet AMD. CABERNET is a multicentre,
randomised, controlled study of 450 patients
enrolled at clinical centres worldwide. It is
evaluating the safety and efficacy of epiretinal
brachytherapy delivered via limited
vitrectomy, concomitant with two intravitreal
injections of the antiangiogenic therapy
ranibizumab (Lucentis, Genentech) vs.
ranibizumab alone. NeoVista recently
received the CE Mark for the device
www.neovistainc.com
Bepotastine results encouraging
ISTA Pharmaceuticals announced
“encouraging” preliminary results from a
phase III clinical study of bepotastine
ophthalmic solution (Bepreve).The
multicentre, double blind, placebo-controlled
study compared the onset and duration of
effect of two concentrations of the drug in
130 patients with a history of ocular
allergies.The company reported that both
concentrations of the drug produced
statistically significant reductions in the
primary study endpoint, ocular itching. Both
concentrations also produced significant
effects on the rapidity of response and in the
secondary endpoints measuring additional
signs and symptoms of ocular allergy, as well
as in improvement in total nasal symptoms.
There were no serious ocular adverse
events, the company said.The company will
now pursue regulatory approval of the drug.
www.ista.com
Company News
Alcon shareholders get a boost
Alcon announced a dividend of 2.63 Swiss
francs per share at it annual general meeting
in Zug, Switzerland.The company’s Board of
Directors re-elected Cary Rayment as its
chairman and re-elected Francisco Castañer
as its vice-chairman.The company re-elected
Thomas G Plaskett and Paul Polman to the
Board and added Paul Bulcke, James Singh,
and Dr Daniel Vasella as new members.
www.alcon.com
Contacts get a boost from LASIK
phobia?
Recent negative publicity about the dangers
of LASIK appears to be driving an increase in
inquiries for therapeutic contact lenses,
reports Paragon Vision Sciences, maker of
Paragon CRT® contact lenses.The company
reported a surge in interest about this
approach that is said to reshape the myopic
cornea during sleep.The FDA has approved
the lenses.
www.paragoncrt.com
Bausch to collaborate with Belgian
company
Bausch & Lomb has entered into a
collaborative research agreement with
Galapagos NV, a Belgian drug discovery
company.The agreement gives Bausch the
exclusive option to license select Galapagos
compounds as development candidates for
therapeutic uses in ophthalmic diseases.
Bausch will be responsible for the preclinical
and clinical development of the select
compounds for use in ophthalmic diseases.
www.bausch.com
OcuSense tear-testing platform scales
up
California start-up OcuSense announced it is
ready to begin scaling up to produce its
TearLab™ tear-testing platform.The in vitro
system is designed to allow clinical
assessment of tear disorders.The company
recently received ISO certification for its
system. OcuSense is a subsidiary of
Occulogix.
www.ocusense.com
Product Launches
Inamura Super III Capsulorhexis Forceps
ASICO launched a new product, the Inamura Super III Capsulorhexis Forceps (AE-4346).
Although similar to a standard capsulorhexis forceps in design, the movement of the new
forceps is like a cross-action forceps the company says.This patented technology will not
increase wound size and will reduce the loss of viscoelastic. For more accurate results
while completing capsulorhexis, the handle of the forceps was designed to be more
sensitive to fingertip pressure. The tips are very delicate for ideal puncturing and grasping
of the anterior capsule. Jaws open completely for easy cleaning when not in use.
www.asico.com
49