Back to Homepage
Search
Advanced Search
Daily Archives

Click here for the EyeWorld Show Daily

Ophthalmology Business

View Latest Issue

Resources

Ophthalmologists

Practice Managers

Patient Education

eyeCONNECT Community

IOL Calculator
Volume 17, Number 2
January 09, 2012
First patient enrolled in anterior uveitis study
Phase I results for NAION study show promise
Sun, latitude, gender: all triggers for glaucoma
MacuCLEAR raises more than $1 million
Regeneron, Genentech settle patent litigation
Iridex sells aesthetic business line

First patient enrolled in anterior uveitis study

A milestone phase III pivotal study evaluating EGP-437 (dexamethasone phosphate formulated for iontophoresis) for the treatment of anterior uveitis has enrolled its first patient, developer EyeGate Pharma (Waltham, Mass.) said in a news item.
The randomized, double-masked, positive-controlled, non-inferiority study will enroll up to 200 subjects at more than 20 U.S. sites in order to assess the effectiveness of EGP-437 in comparison to topically applied prednisolone acetate eye drops, the company said. EGP-437 will be administered using the EyeGate II Drug Delivery System, a non-invasive iontophoretic drug delivery technology.
The phase II results (published in this month’s Ophthalmology) showed about 66% of enrolled patients achieved an anterior chamber cell score of zero within 28 days after a single iontophoresis treatment, with no alteration in intraocular pressure or cataract formation detected. EGP-437 has been granted orphan drug designation by both the FDA and European Medicines Evaluation Agency for corneal graft rejection.

back to top

Phase I results for NAION study show promise

Interim results from the first two cohorts of a phase I clinical study of QPI-1007, a synthetic siRNA drug candidate for ocular neuroprotection in patients with recent onset of non-arteritic anterior ischemic optic neuropathy (NAION), found no dose limiting toxicities up to and including the highest dose tested (6 mg) following intravitreal injection, developer Quark Pharmaceuticals (Fremont, Calif.) said in a news release.
A total of 38 patients were enrolled in two arms at 22 sites across the U.S. and six sites in Israel: Stratum I was a dose-escalation safety study in patients who are legally blind secondary to chronic optic nerve atrophy or retinal degeneration and is fully enrolled; Stratum II was designed to further evaluate safety and to assess for potential biological activity of QPI-1007 in recent-onset NAION patients by monitoring changes in visual function following drug administration. In Stratum II, two cohorts of 10 patients each were given a single intravitreal injection of one of two doses of QPI-1007. After 1 month of follow-up, 40% of patients in Cohort 1 and 60% of patients in Cohort 2 gained three or more lines of visual acuity. At 3 months, average letter gain was 14 in both dosing groups, and none of the patients lost vision compared to screening data. Evaluation of these patients is ongoing, with additional assessments planned at 6- and 12-months post-injection.

back to top

Sun, latitude, gender: all triggers for glaucoma

Age, gender, and geographic location are all factors for developing exfoliation syndrome (ES), said Louis Pasquale, M.D., director of Massachusetts Eye and Ear's Glaucoma Center of Excellence, Boston, in a study published in this month’s Ophthalmology. The researchers found ES is not a disease of Norwegian descent and that “where you live does matter when it comes to developing the disease,” Dr. Pasquale said in a news release.
Researchers used data from 78,955 women in the Nurses' Health Study (NHS) and 41,191 men in the Health Professionals Follow-up Study (HPFS) residing throughout the continental United States who were prospectively followed for 20 years or more and who provided lifetime residence information to examine the descriptive epidemiologic features of ES or exfoliation glaucoma suspect (EGS). “Importantly, those with a lifetime residential history of living in the middle tier and south tier of the United States was associated with 47% and 75% reduced risks, respectively, compared with living in the northern tier, and across the life span, residence at age 15 was the most strongly associated with risk, followed by current residence,” the study found.

back to top

MacuCLEAR raises more than $1 million

MacuCLEAR (Plano, Texas) has raised more than $1 million to continue developing MC-1101, a topically administered eye drop for the treatment and progression-prevention of dry age-related macular degeneration (AMD) to the neovascular form, the company said in a news release. The funds have been earmarked to complete a pivotal phase IIIa study. MC-1101 works by increasing ocular blood flow in the choroidal vessels, thereby preventing the progression of AMD from the dry to wet forms. MC-1101 has been previously approved by U.S. regulators as an oral antihypertensive drug; the ophthalmic version has been granted Fast Track status.

back to top

Regeneron, Genentech settle patent litigation

Regeneron Pharmaceuticals (Tarrytown, N.Y.) has settled a patent dispute with Genentech (South San Francisco, Calif.) over age-related macular degeneration drug EYLEA (aflibercept) and will make payments based on U.S. sales and receive a license to some patents. Regeneron will pay $60 million upon cumulative U.S. sales of EYLEA reaching $400 million. Regeneron will also pay royalties of 4.75% on cumulative U.S. sales of EYLEA between $400 million and $3 billion and 5.5% on any cumulative U.S. sales of EYLEA over $3 billion.

back to top

Iridex sells aesthetic business line

Iridex (Mountain View, Calif.) has sold its global aesthetic business for $5.1 million to Australia-based Cutera (Brisbane) to refocus itself on ophthalmology, the company said. The transaction is expected to close in early 2012 and has been approved by both boards of directors.

back to top

RESEARCH BRIEFS

  • Refractive shifts in pseudophakic eyes continues to occur in children even after their 10th birthday, which may have ramifications for the use of multifocal lenses and IOL power selection, according to Rupal H. Trivedi, M.D., and colleagues. The group studied 114 pseudophakic eyes (114 patients) with at least two refractions at a minimum of a 1-year interval after the 10th birthday. The mean initial refraction was −0.65 D± 2.27 D and the mean final refraction, −1.78±2.82 D. The mean shift in refraction was −1.13±1.36 D; the mean shift in refraction per year was −0.30±0.38 D. There was a myopic shift in refraction in 86.8% of eyes; 64.0% of eyes had up to a 0.50 D myopic shift per year. Age at the time of IOL implantation (before or after 10 years of age) did not influence the refractive shift in pseudophakic eyes. In the 27 cases with fellow eye data, the mean refractive shift per year was −0.19 D in the operated eye and −0.22 D in the fellow eye. The study is published in the Journal of Cataract & Refractive Surgery.
  • Irradiation with visible light does not seem to be harmful to the human lens except if the lens is exposed to laser irradiances that are high enough to warrant thermal protein denaturation that is more readily seen using pulsed laser systems, according to a study. Line Kessel and colleagues in Denmark examined the optical effects on human lenses of short wavelength visible light and ultraviolet radiation. Naturally aged human donor lenses were irradiated with UVA (355 nm), violet (400 and 405 nm), and green (532 nm) lasers. Irradiation with high intensity lasers caused scattering lesions in the human lenses. These effects were more likely to be seen when using pulsed lasers because of the high pulse intensity. Prolonged irradiation with UVA led to photodarkening, whereas no detrimental effects were observed after irradiation with visible light. The article is published in BMC Ophthalmology.
  • An Australian study investigating the ideal correction of IOL power for sulcus implantation has concluded the IOL power should be adjusted according to the measured axial length and predicted IOL power. For patients with a predicted IOL power from 18 to 25 D, power should be reduced by at least 1 D; for lenses >25 D, power should be reduced by 1.5 to 2 D. Rahul Dubey and colleagues retrospectively analyzed data from 679 patients who underwent phaco from June 2007-June 2008. Patients in the study population had their IOL power reduced by 0.5 or 1 D from that calculated by the SRK-T formula for in-the-bag implantation. The IOL implanted was the foldable three-piece acrylic AcrySof MA60AC (Alcon, Fort Worth, Texas). Posterior capsule tears requiring implantation of IOL in the ciliary sulcus occurred in 36 eyes. When comparing eyes in which the power was reduced by 0.5 D with those in which the reduction was 1.0 D, those with a power reduction of 1.0 D had significantly less unexpected error. The article is in press in Ophthalmology.
back to top

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

For sponsorship opportunities or membership information, contact:
ASCRS•ASOA • 4000 Legato Rd. • Suite 700 • Fairfax, VA 22033 • Phone: 703-591-2220 • Fax: 703-591-0614 • 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.

Search Archives


ASCRS
Copyright © 1997-2014 EyeWorld News Service
This site is optimized for 1024 X 768 Resolution