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B+L, ISTA end waiting period
Bausch + Lomb (Rochester, N.Y.) has received early termination of the
required waiting period to purchase Irvine, Calif.-based ISTA
Pharmaceuticals, the company said. The early termination under the HartScott-Rodino Antitrust Improvements Act of 1976 allows the acquisition to
close during the second quarter, B+L said. The deal remains subject to
approval by ISTA’s stockholders, among other conditions.
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Iluvien receives Austrian marketing
authorization
Iluvien (fluocinolone acetonide, Alimera Sciences, Alpharetta, Ga.) has
received marketing approval from the Austrian Agency for Health and Food
Safety. The sustained release intravitreal injection has been approved for
the treatment of diabetic macular edema.
Iluvien is a 190 mg implant that “provides a therapeutic effect of up to 36
months,” Alimera said.
The Austrian approval marks the first national authorization in the E.U.,
Alimera stated in a news release.
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Hypotrichosis treatment completes Phase I
study
A novel physiologically active fatty acid derivative (RK-023) has completed
a Phase I clinical study for the treatment of hypotrichosis of the eyelashes,
developer R-Tech Ueno (Tokyo) said in a news release. The study was a
double-masked, placebo-controlled trial to evaluate the safety, tolerability,
and pharmacokinetics of RK-023 in eight healthy adult males and females
each (16 subjects in total) by applying the study drug to the eyelid margin
(at the base of the eyelashes) of the subjects for 5 consecutive days, the
company said. A second Phase I study evaluated the safety and
pharmacokinetics after a single instillation in three healthy male eyes. No
adverse drug reactions were observed in either study, and no ophthalmic
findings were observed, the company said. The pharmacokinetics
evaluation also showed there were “hardly any safety concerns” with the
compound. RK-023 is also in development for androgenic alopecia.
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CZM to start ReLEx smile study
Carl Zeiss Meditec (CZM, Dublin, Calif.) will begin a U.S. study to evaluate
the ReLEx smile procedure for the correction of myopia, the company said.
The ReLEx smile technique for refractive surgery “combines femtosecond
laser technology and precise lenticule extraction for minimally invasive
laser vision correction,” CZM said. The ReLEx smile method generates a
refractive lenticule in the intact cornea with the femtosecond laser. The
surgeon then removes the lenticule through a small, <4 mm incision
without needing to move the patient to an excimer laser. CZM will begin
patient enrollment in the next few months.
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BPEI researchers define role of cochlin
Researchers at Bascom Palmer Eye Institute (BPEI, Miami) have confirmed
an earlier hypothesis that the response of aqueous humor to mechanical
stimuli at the cellular level (mechanosensing) impacts the regulation of
intraocular pressure (IOP) through cells, converting that stimuli into
chemical activity (mechanotransduction), BPEI said in a news release. At
the center of the discovery lies the protein cochlin, which the researchers
initially found in the trabecular meshwork almost 7 years ago.
Mechanosensing of fluid flow is transduced by TREK-1 mechanotransducers
on the cell surface. TREK -1 is a protein in the trabecular meshwork, but
how it affects IOP was previously unknown. Also missing was an
understanding of how cochlin works in mechanosensing. However, the
researchers found TREK 1 functions in conjunction with cochlin to regulate
IOP.
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Iris Pharma, RxGen announce strategic alliance
Iris Pharma (La Gaude, France) and RxGen (Hamden, Conn.) have
established a strategic alliance to offer fully integrated “bench-to-bedside”
ophthalmology research services, the companies jointly announced. Iris
Pharma may now offer immediate access to RxGen’s non-human primate
ophthalmic research models and related preclinical in vivo services.
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FDA issues second Warning to Physicians
FDA received additional reports of fungal endophthalmitis in patients who
were give Brilliant Blue G during eye surgery since its initial Warning to
Physicians was posted last month. In that time, the agency has received
reports of eye infections in patients who were given injections of drug
products containing triamcinolone during eye surgery. The FDA said the
drugs were supplied by Franck’s Pharmacy in Ocala, Fla., and that the
Centers for Disease Control and Prevention has advised healthcare
personnel to stop use of all sterile triamcinolone products purchased from
Franck’s until further notice.
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RESEARCH BRIEFS
An evaluation of the effects of different contact lens-based artificial
pupil designs on visual performance found soft contact lens (CL)
apertures provide good visual acuity at a distance, functional
intermediate vision, and poor near visual acuity and stereoacuity.
Santiago Garcia-Lazaro, Ph.D., and colleagues evaluated presbyopic
patients using four artificial pupil designs in the non-dominant eye.
Results showed the mean UDVA and CDVA ranged from 0.04±0.05
to −0.01±0.04 logMAR and from −0.02±0.05 to −0.05±0.03
logMAR, respectively. The UNVA and DCNVA ranged from 0.37±0.11
to 0.42±0.20 logMAR and from 0.35±0.17 to 0.38±0.12 logMAR,
respectively. The difference in binocular distance contrast sensitivity
was statistically significant between the pinhole systems and the
control group for six cycles per degree (cpd), 12 cpd, and 18 cpd.
Near vision differences were also significant for three cpd at the two
luminance levels (P<.05). Stereoacuity values for near vision were
not significantly different between the four pinhole systems (P>.05).
This study is published in the Journal of Cataract & Refractive
Surgery.
Anti-vascular endothelial growth factor (VEGF) therapy may have a
potential role in treating anterior segment neovascular disorders,
according to Hamid Hosseini, M.D., and colleagues. They
conducted a literature review to determine the role bevacizumab
may play in anterior segment eye disorders. The study found that
response to bevacizumab anti-VEGF therapy is variable, but VEGF
agents are especially effective when administered early, before
anatomical changes. Neovascularization can recur if the ischemic or
inflammatory process is not reversed. Eyes with long-standing
diseases, such as autoimmune disorders that involve ongoing
inflammation and VEGF production, seem to be less responsive to
bevacizumab. The researchers suggested controlled prospective
trials are needed to establish the long-term safety, efficacy, and
dosing guidelines for the use of anti-VEGF agents in anterior
segment neovascularization. The study is published in Cornea.
Patients with advanced bilateral 24-2 visual field (VF) loss because
of glaucoma, significant 10-2 VF loss, or poor contrast sensitivity
(CS) are more likely to experience problems with face recognition.
Fiona C. Glen and colleagues compared glaucomatous patients with
a range of visual field defects to age-matched visually healthy
controls. Participants underwent cognitive and visual assessment
and were classified as having “early,” “moderate,” or “advanced” VF
defects. Patients with advanced VF defects identified fewer faces on
average (66±15%) than those with early (75±11%) and moderate
(75±13%) defects and controls [(75±11%); p<0.05]. Multiple
regression analysis revealed CS was important for face recognition.
This study is published in Investigative Ophthalmology and Visual
Science.
NEW PRODUCT BRIEFS
Bausch + Lomb (Rochester, N.Y.) unveiled additions to its Storz
Ophthalmic Instruments silicone CapsuleGuard IA line at the 2012
ASCRS Annual Meeting. The line has expanded to 10 single-use
instruments, including the MICS 1.8 incision option along with the
standard 2.2 to 2.8 incision ranges. The line is compatible with the
company’s Stellaris PC Vision Enhancement System along with other
ophthalmic platforms, the company said.
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EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.
EyeWorld Week Online (ISSN 1089-0319), a digital publication of the American Society of Cataract
and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every
Friday, distributed by email, and posted live on Friday.
Medical Editors: David F. Chang, M.D., chief medical editor; Bonnie An Henderson, M.D.,
cataract editor; Edward J. Holland, M.D., cornea editor; Reay H. Brown, M.D., glaucoma editor;
Kerry D. Solomon, M.D., refractive editor; and John A. Vukich, M.D., international editor
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ASCRS•ASOA • 4000 Legato Rd. • Suite 700 • Fairfax, VA 22033 • Phone: 703-591-2220 • Fax: 703591-0614 • Email: ASCRS
Opinions expressed in EyeWorld Week do not necessarily reflect those of ASCRS•ASOA. Mention of
products or services does not constitute an endorsement by ASCRS•ASOA.