Eyeworld.org EW Week Vol.17 No.8 # 27 March, 2012

Spectralis Anterior Segment Module gains U.S. approval

Tue, 27 Mar 2012 12:44:40 -0500

The FDA has granted regulatory approval for the Spectralis Anterior Segment Module to developer Heidelberg Engineering (Heidelberg, Germany). “The Anterior Segment Module provides high-resolution images of the cornea, anterior chamber angle, and sclera,” the company said in a press release. “Clinicians can assess both chamber angles at the same time using a 16 mm-wide angle-to-angle optical coherence tomography scan.”

Omeros OMS302 achieves endpoints in Phase III study

Tue, 27 Mar 2012 12:44:40 -0500

A Phase III trial evaluating OMS302 (ketorolac/phenylephrine) in patients undergoing lens replacement surgery met its endpoints, developer Omeros (Seattle) said in a news release. OMS302 met its primary endpoint by demonstrating statistically significant (p<0.00001) maintenance of intraoperative mydriasis, the company said. It was also statistically superior to placebo in reduction of pain in the early post-op period, the company added.
The Phase III study enrolled 405 patients randomized 1:1 to receive either OMS302 or placebo. The most common adverse events were those related to surgery, specifically eye pain, eye inflammation, headache, and increased intraocular pressure. The incidence of these adverse events was similar between OMS302- and placebo-treated patients. OMS302 is added to standard irrigation solution used in lens replacement surgery and delivered intracamerally to maintain intraoperative mydriasis (pupil dilation), to prevent surgically induced miosis (pupil constriction), and to reduce post-op pain and irritation, Omeros said.

BOL-303259-X meets primary endpoint in Phase IIb study

Tue, 27 Mar 2012 12:44:40 -0500

BOL-303259-X, a novel nitric oxide-donating prostaglandin F2â€‘alpha analog, met its primary endpoint in a Phase IIb study in patients with open-angle glaucoma or ocular hypertension, developers NicOx (Sophia Antipolis, France) and Bausch + Lomb (Rochester, N.Y.) said. The compound (previously NCX-116) was licensed by NicOx to B+L 2 years ago.
The Phase IIb study showed positive results on a number of secondary endpoints. The primary efficacy endpoint was the reduction in mean diurnal IOP on day 28. BOLâ€‘303259â€‘X consistently lowered IOP in a dose-dependent manner. Two of the four doses tested showed greater IOP reduction compared with latanoprost 0.005%, with the differences reaching more than 1 mm Hg (statistical significance: P<0.01).
The most efficacious dose of BOLâ€‘303259â€‘X also showed positive results on a number of secondary endpoints, including consistently better control of IOP over 24 hours on day 28, as well as a statistically significant greater percentage of responders versus latanoprost 0.005%, defined as patients achieving an IOP of 18 mm Hg or less. The responder rate was 68.7% for the most efficacious dose of BOLâ€‘303259â€‘X, compared to 47.5% for latanoprost 0.005% (P=0.006). B+L licensed the compound from NicOx in 2010; the results from this study will lead to a $10 million payment and initiation of a Phase III study.

University of Wisconsin produces retinal structures from stem cells

Tue, 27 Mar 2012 12:44:40 -0500

Researchers at University of Wisconsin-Madison have made early retinal structures containing proliferating neuroretinal progenitor cells using induced pluripotent stem (iPS) cells derived from human blood, the University said in a press release.
The structures also showed the capacity to form layers of cells, and the cells possessed the machinery that could allow them to communicate information. The University said the findings “suggest that it is possible to assemble human retinal cells into more complex retinal tissues, all starting from a routine patient blood sample.” About 16% of the initial retinal structures developed distinct layers, the school said. The outermost layer primarily contained photoreceptors, whereas the middle and inner layers harbored intermediary retinal neurons and ganglion cells, respectively.

RetCam to be distributed in Russia

Tue, 27 Mar 2012 12:44:40 -0500

The Russian Federation has agreed to implement the RetCam System (Clarity Medical Systems, Pleasanton, Calif.) in half its states, Clarity said in a news release. The system will be used in care centers handling prematurely born infants at risk for retinopathy of prematurity.

Avada Hearing promotes hearing centers to ophthalmologists

Tue, 27 Mar 2012 12:44:40 -0500

Avada Audiology and Hearing (Louisville, Ky.) has created a new division to help physicians develop hearing centers in ophthalmic offices, the company said. Avada currently has “several hundred” hearing healthcare centers in 20 states.

LensAR raises $24 million in financing

Tue, 27 Mar 2012 12:44:40 -0500

LensAR (Orlando, Fla.) has raised an additional $24 million in private financing to support the commercial launch of its femtosecond for refractive cataract surgery laser, the company said. The LensAR Laser System has been cleared by U.S. regulators for anterior capsulotomy and lens fragmentation. For other indications it is limited by U.S. law to investigational use only.

pSivida, Neuron ink deal

Tue, 27 Mar 2012 12:44:40 -0500

pSivida Corp. (Watertown, Mass.) and Neuron Systems (Burlington, Mass.) will evaluate the use of pSividaâ€™s Durasert drug delivery technology as a treatment for dry age-related macular degeneration (AMD), the company said. pSivida is also independently developing a product to treat posterior uveitis and a product to treat glaucoma and ocular hypertension in collaboration with Pfizer (New York).

Tue, 27 Mar 2012 12:44:40 -0500

RESEARCH BRIEFS

Modern surgical techniques do not eliminate the early development of glaucoma following congenital cataract surgery with or without an IOL implant, according to the Infant Aphakia Treatment Study (IATS). Allen B. Beck, M.D., and fellow investigators evaluated 114 infants between 1 and 6 months of age with a unilateral congenital cataract assigned to undergo cataract surgery either with or without an IOL implant. Ten patients (9%) developed glaucoma and four (4%) had glaucoma suspect, yielding a total of 12% with a glaucoma-related adverse event in the treated eye through the first year of follow-up. Of the 57 patients who underwent lensectomy and anterior vitrectomy, five (9%) developed a glaucoma-related adverse event; of the 57 patients who underwent an IOL implant, nine (16%) developed a glaucoma-related adverse event. Five-year follow-up data will likely reveal more glaucoma-related adverse events, the group wrote in Archives of Ophthalmology.
The increase of optical side effects was reproducibly dependent on the geometry of the laser structure in a single-masked study of femtosecond laser therapy in the treatment of presbyopia. Monika Peter and colleagues simulated the therapy by applying the patterns into standard contact lenses (CLs). In the first part of the study, the influence of the numerical aperture on optical side effects was investigated by comparing a typical femtosecond-LASIK configuration to a femtosecond-presbyopia treatment (N=11). The second part focused on a possible improvement of visual performance by comparing a regular grid pattern to a randomly chosen spacing of the laser spots (N=16). The laser-treated and standard CL indicated no significant difference in visual acuity, contrast sensitivity, and mesopic vision without glare. While wearing modified lenses with a regular grid, quality of vision decreased significantly by means of mesopic vision with glare and subjective straylight. The study is published in Graefeâ€™s Archive for Clinical and Experimental Ophthalmology.
In a study of pseudophakic subjects with low levels of post-op astigmatism, full correction yielded significantly better reading performance and high- and low-contrast visual acuity than spherical equivalent correction, according to a study from Robert P. Lehmann, M.D., and Diane M. Houtman, O.D. The study evaluated 38 patients who had been implanted with an aspheric IOL and had 0.5-0.75 D of post-op astigmatism. Monocular visual performance using full correction was compared with visual performance using spherical equivalent correction. Visual acuities at three contrast levels (100%, 25%, and 9%) were significantly better using full correction than when using spherical equivalent correction. For contrast sensitivity testing under photopic, mesopic, and mesopic with glare conditions, only 1 out of 12 outcomes demonstrated a significant improvement with full correction compared with spherical equivalent correction. The study is published in Clinical Ophthalmology.