Review of Ophthalmology

Merck’s Zioptan Joins Prostaglandin Market

Staff
4/5/2012

The Food and Drug Administration has approved Merck’s Zioptan (tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution. Zioptan is approved for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. 

Zioptan may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, color, thickness, shape and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment. 

The FDA approval of Zioptan was based on efficacy and safety results from five controlled clinical studies in 905 patients. Both preservative-containing and preservative-free formulations of tafluprost were used in these clinical studies. 

In clinical studies of up to two years in duration, Zioptan, dosed once-daily in the evening lowered IOP by 6 to 8 mmHg at three months and by 5 to 8 mmHg at six months, from a baseline pressure of 23 to 26 mmHg. For information, visit merck.com


Enhanced Viewing with New Kowa Retinal Camera
Kowa Optimed received 510(k) approval from the FDA for the marketing of its latest model, the VX-20 retinal camera. Like the VX-10, the VX-20 offers non-mydriatic, mydriatic and FA modes with 50-degree and 30-degree views.

Additionally the VX-20 has an autofluorescence mode to provide further diagnostic investigation of the health of the retina. Linked to VK-2 software, the VX-20 provides options for fundus image analysis. With the built-in PC and high resolution camera back, this fundus camera is a versatile diagnostic tool with stand-alone capability. 

Kowa VX-20 features include: the optional VK-2 high performance and digital imaging software, which allows for enhanced viewing and image manipulation for further diagnostic investigation; a built-in PC with a high- resolution camera back; and Digiversal software that automatically converges patient image files from multiple pieces of diagnostic equipment into a single file on a single screen. This software solution makes image organization and comparison seamless and easy, the company says. For information, call 1 (800) 966-5692 or visit kowa-usa.com/eyecare


 
 
Moria: Caro Manipulator for LASIK Flap Massage
Although a thin LASIK flap minimizes the risk of postoperative corneal ectasia, sub-Bowman’s keratomileusis using an automated microkeratome or femtosecond laser can sometimes be associated with folds and microstriae. This may require retreatment and is viewed unfavorably by patients.

Product Research News
Two studies supported by Allergan looked at different aspects of the company’s dexamethasone intravitreal implant, Ozurdex, based on data from the GENEVA study groups.
The first investigated whether intraocular pressure elevation (a common adverse event of intravitreal corticosteroid injection) after dexamethasone implant treatment impacts efficacy outcomes. The study sought to: identify potential risk factors for IOP elevation after dexamethasone implant treatment; compare the VA outcomes between patients with or without IOP elevation; compare the anatomical outcome (i.e., optical coherence tomography) between patients with or without IOP elevation.
Patients were categorized into two groups by whether they ever had IOP elevation at any follow-up visit. Four definitions of IOP elevation were considered: IOP increase by ≥10 mmHg from baseline; IOP ≥30 mmHg; IOP ≥22 mmHg; initiate new IOP-lowering medicine after baseline.
Key results included:
• Younger age was identified as a risk factor for IOP elevation, which is consistent with previous studies of intravitreal triamcinolone. 
• Male gender was found to be a significant predictor for IOP elevation after dexamethasone implant treatment. 
• After adjusting for other confounders, age and gender remain statistically significant factors that are associated with IOP elevation. 
• Although IOP elevation is commonly observed after dexamethasone implant treatment, patients’ ability to obtain BCVA and OCT improvement seems unaffected. At some time points patients with IOP elevation had greater outcome improvement thanthose without IOP elevation.
The authors caution that the findings are associations, not necessarily causal relationships; and that the findings may not extrapolate to other types of intravitreal corticosteroids (e.g., triamcinolone).

Intraocular Pressure (IOP) Elevation and Visual Acuity (VA) in Retinal Vein Occlusion (RVO) With Dexamethasone Implant Treatment.  Sadda S, Yeh W, Grace H. Pan G, Hashad Y, et al. Presented at: 115th Annual Meeting of the American Academy of Ophthalmology.

The second study evaluated the safety and efficacy of one or two treatments with dexamethasone intravitreal implant over 12 months in 1,256 patients with vision loss from macular edema owing to branch or central retinal vein occlusion. Two identical, multicenter, prospective studies included a randomized, six-month, double-masked, sham-controlled phase followed by a six-month, open-label extension.
At baseline, patients received dexamethasone implant 0.7 mg (n=421), dexamethasone implant 0.35 mg (n=412), or sham (n=423) in the study eye. At day 180, patients could receive dexamethasone implant 0.7 mg if best-corrected visual acuity was <84 letters or retinal thickness was >250 μm.
At day 180, 997 patients received open-label dexamethasone implant. Except for cataract, the incidence of ocular adverse events was similar in patients who received their first or second dexamethasone implant. Over 12 months, cataract progression occurred in 90 of 302 phakic eyes (29.8 percent) that received two dexamethasone implant 0.7 mg injections versus five of 88 sham-treated phakic eyes (5.7 percent); cataract surgery was performed in four of 302 (1.3 percent) and one of 88 (1.1 percent) eyes, respectively. In the group receiving two 0.7-mg dexamethasone implants (n=341), a ≥10-mmHg intraocular pressure increase from baseline was observed in 12.6 percent after the first treatment, and 15.4 percent after the second. The IOP increases were usually transient and controlled with medication or observation; an additional 10.3 percent of patients initiated IOP-lowering medications after the second treatment. A ≥15-letter improvement in BCVA from baseline was achieved in 30 percent of patients 60 days after the first and in 32 percent of patients 60 days after the second dexamethasone implant.
Among patients with macular edema owing to BRVO or CRVO, single and repeated treatment with dexamethasone implant had a favorable safety profile over 12 months. In patients who qualified for and received two dexamethasone implant injections, the efficacy and safety of the two implants were similar with the exception of cataract progression.

Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, et al. Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results. Ophthalmology 2011 Dec;118(12):2453-60. Epub 2011 Jul 20.
Moria says that’s that’s why it launched a dedicated hand-held instrument for external flap massage that can be used either intraoperatively (preventive massage) and/or in the postoperative time (therapeutic massage); the Caro Manipulator has a hemispherical, highly polished tip to avoid damage to the epithelium.

For more information, visit  moria-surgical.com.


Precision Low-Vision
If you have patients struggling with low vision, Precision Vision has introduced a new line of hand magnifiers that may be able to help.

The Ergo-Lux hand magnifiers are illuminated, and feature a four-chip, surface-mounted light-emitting diode. The company says the Ergo-Lux’s design supports the user’s hand and arm to ensure a natural, stress-free reading position, and that the correct distance between the object and the lens is automatically found when the device’s handle sits on the object. Precision Vision adds that the SMD LED generates very bright, consistent, high-contrast light that is the ideal illumination for the visual task at hand. The Ergo-Lux runs on three AAA batteries that the company says are easy to change, thanks to a special closing mechanism in the device’s handle.  

The Ergo-Lux comes in five magnification powers between 8 and 24 D in 4-D increments, but is also available as a boxed set with all of the powers. For information, visit precision-vision.com.


Anterior Segment Module Adds to Spectralis Capabilities
The FDA also granted clearance for Heidelberg Engineering’s new Spectralis Anterior Segment Module. The ASM provides high-resolution images of the cornea, anterior chamber angle and sclera utilizing Heidelberg Noise Reduction technology for enhanced detail. Clinicians can assess both chamber angles at the same time using a 16 mm-wide, angle-to-angle OCT scan.

“The Spectralis Anterior Segment Module paves the way towards digital gonioscopy,” said Sanjay Asrani, MD, associate professor of ophthalmology, Duke University Eye Center. “Glaucoma surgeons will further benefit from the enhanced depth imaging OCT capabilities of Spectralis when assessing filtering blebs and anterior chamber angles.”

The ASM broadens the range of applications of all Spectralis SD-OCT models, such as BluePeak blue laser autofluorescence, wide field composite imaging as well as fluorescein and ICG video angiography available for Spectralis devices. For information, visit heidelbergengineering.com.  REVIEW


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