Volume 5, Number 34
Monday, August 29, 2005



In this issue: (click heading to view article)
Mycophenolate Mofetil Therapy for Inflammatory Eye Disease
Tono-Pen Accuracy in Measuring IOP of Congenital Glaucoma Patients
Complicating Factors for Visual Acuity Following Cataract Extraction with Dislocated Lens Fragments
Hyperopic Photorefractive Keratectomy: 7.5-year Follow-Up
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Mycophenolate Mofetil Therapy for Inflammatory Eye Disease

Researchers at the Johns Hopkins School of Medicine evaluated treatment outcomes with mycophenolate mofetil in patients with inflammatory eye disease in a retrospective case series.

Eighty-four consecutive patients with inflammatory eye disease treated with mycophenolate mofetil at an academic referral center. Investigators reviewed medical records for treatment with mycophenolate mofetil. They recorded dose of mycophenolate mofetil, response to therapy, dose of prednisone, use of other immunosuppressive drugs and side effects associated with the use of mycophenolate mofetil. Main outcome measures were the ability to control ocular inflammation with mycophenolate mofetil and to taper prednisone to 10 mg or less daily, and incidence of treatment-related side effects.

Of the 84 patients treated with mycophenolate mofetil, 61 percent had uveitis, 17 percent had scleritis, 11 percent had mucous membrane pemphigoid and 11 percent had orbital or other inflammatory disease. Forty-three percent of patients treated with mycophenolate mofetil had been treated with at least one other immunosuppressive drug previously. The median dose of prednisone at the start of mycophenolate mofetil therapy was 40 mg, and 82 percent of the patients were considered a treatment success, as judged by the ability to control the inflammation and taper prednisone to 10 mg or less daily. Median time to treatment success was 3.5 months. Mycophenolate mofetil therapy was discontinued due to insufficient efficacy at a rate of 0.10 per person-year (PY) and due to side effects at a rate of 0.08/PY. The most frequent side effect was gastrointestinal upset, with a rate of 0.19/PY.

The authors believe their data suggest that mycophenolate mofetil may be an effective corticosteroid-sparing agent in treating inflammatory eye disease with a manageable side effect profile.

SOURCE: Thorne JE, Jabs DA, Qazi FA, et al. Mycophenolate mofetil therapy for inflammatory eye disease. Ophthalmol 2005;112(8):1472-7.
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Tono-Pen Accuracy for Measuring IOP in Congenital Glaucoma

This Israeli study sought to compare intraocular pressure (IOP) measurements by Perkins tonometer and Tono-Pen in young children with primary congenital glaucoma (PCG) in a retrospective comparative case series.

Investigators reviewed the clinical records of all children with primary congenital glaucoma who underwent examinations under general anesthesia at Soroka University Medical Center, Beer-Sheva, Israel, between January 1999 and July 2002. They then examined 28 eyes of 16 children under general anesthesia. Mean IOP was 18 +/- 6 mmHg with the Perkins tonometer and 22+/- 8 mmHg with the Tono-Pen.

In 18 eyes, IOP was less than 21 mmHg with the Perkins tonometer; these eyes had already undergone surgical procedures. The other 10 eyes with IOP greater than 21 mmHg with the Perkins tonometer underwent surgery under anesthesia at the end of the examination. In eyes with IOP greater than 16 mmHg (Group A, 18 eyes), investigators found a significant difference between the Perkins and Tono-Pen measurements, even although the values were strongly correlated. In contrast, in eyes with IOP less than 16 mmHg (Group B, 10 eyes), investigators obtained no statistically significant difference and good correlation. A difference of 5.8 +/- 3.8 mm Hg and 0.6 +/- 1.7 mmHg between Perkins and Tono-Pen readings, respectively, was found in Groups A and B. The authors believe that a further study with a similar population is needed to confirm these results.

SOURCE: Levy J, Lifshitz T, Rosen S, et al. Is the Tono-Pen accurate for measuring intraocular pressure in young children with congenital glaucoma? J AAPOS 2005;9(4):321-5.
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Complicating Factors for Visual Acuity Following Cataract Extraction with Dislocated Lens Fragments

A good visual outcome (20/40 or better) is possible in eyes with posteriorly dislocated lens fragments after cataract extraction, even when retinal tears or macula-on retinal detachment is present, according to researchers at New York’s North Shore University Hospital-Long Island Jewish Health System. However, the presence of a macula-off retinal detachment has a significant adverse effect on visual outcome.

The study was a retrospective consecutive series of 307 patients who presented at a referral vitreoretinal practice with posteriorly dislocated lens material after cataract extraction over a period of eight years. Researchers noted the presence of retinal tears (RTs), rhegmatogenous retinal detachment (RRD), endophthalmitis and choroidal hemorrhage, as well as their effects on visual outcome. Fifty-eight eyes (19 percent) were managed medically (Group I); the other 249 eyes (81 percent) underwent pars plana vitrectomy for removal of the lens material (Group II). Indications for surgical management included uncontrolled inflammation, elevated intraocular pressure and large lens fragments.

No eyes in Group I developed RT or RRD. Of the 249 Group II eyes, 13 (5 percent) had RT, and 25 (10 percent) developed RRD. In Group II, choroidal hemorrhage and endophthalmitis were found in 12 (5 percent) and four (2 percent) eyes, respectively. Fifty-one (88 percent) of 58 eyes in Group I and 138 (55 percent) of 249 eyes in Group II achieved a final visual acuity of 20/40 or better. Seven (54 percent) of the 13 eyes with RT and 9 (36 percent) of the 25 eyes with RRD achieved a final visual acuity of 20/40 or better. In the RRD group, 9 (56 percent) of the 16 macula-on eyes achieved a final visual acuity of 20/40 or better; none of the 9 macula-off eyes had a final visual acuity of 20/40 or better. None of the four eyes with endophthalmitis and only one (8 percent) of the 12 eyes with choroidal hemorrhage had a final visual acuity of 20/40 or better. Five (62 percent) of eight eyes with retinal detachment treated with pneumatic retinopexy needed further treatment with scleral buckle to achieve anatomical reattachment. Pneumatic retinopexy is not associated with retinal reattachment in many cases, and is not preferred.

SOURCE: Salam GA, Greene JM, Deramo VA, et al. Retinal tears and retinal detachment as factors affecting visual outcome after cataract extraction complicated by posteriorly dislocated lens material. Retina 2005;25(5):570-5.
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Hyperopic Photorefractive Keratectomy: 7.5-year Follow-Up

The refractive stability and safety of hyperopic photorefractive keratectomy (H-PRK) achieved at one year can be maintained up to 7.5 years, with no evidence of hyperopic shift, diurnal fluctuation or late regression, according to results of a long-term prospective study by British investigators.

Twenty-one patients (49 percent, 40 eyes) of 43 patients who participated in one of the first clinical trials of H-PRK were assessed at a mean follow-up of 90.7 months (range 62 to 106 months). The investigators performed H-PRK using a Summit Technology Apex Plus Excimer laser (Summit Technology, Inc.). The mean preoperative spherical equivalent refraction (SEQ) was +4.70D (range +2.00D to +7.50D). Patients were allocated to one of four treatment groups based on their preoperative refraction and received one of the following spherical corrections: +1.50D, +3.00D, +4.50D or +6.00D.

At 7.5 years, the refractive correction remained stable with a mean difference in SEQ of +0.28D between one year and 7.5 years. The mean manifest SEQ was +0.83D (range +5.00D to -3.00D). Sixty-seven percent of eyes having corrections of +1.50D and +3.00D were within +/-1.00D of the predicted correction. Predictability was poorer with +4.50D and +6.00D corrections, with 40 percent of eyes within +/-1.00D of that expected. An improvement in uncorrected near acuity was achieved in 35 eyes (87.5 percent), and 35 eyes (87.5 percent) showed an improvement in uncorrected distance acuity from preoperative levels. Best spectacle-corrected visual acuity (BSCVA) was unchanged or improved from preoperative values in 25 eyes (62.5 percent). Three eyes (8 percent) lost two lines of Snellen BSCVA, which in two cases was attributable to cataract formation. A peripheral ring of haze, 6.5 mm in diameter, appeared in most eyes. Its intensity was greatest at six months and then diminished with time. In 10 eyes (25 percent), remnants of the haze ring were evident at 7.5 years, and subepithelial iron rings 6.5 mm in diameter were evident in 26 eyes (70 percent). No patient complained of night-vision problems and no eye developed ectasia.

SOURCE: O"Brart DP, Patsoura E, Jaycock P, et al. Excimer laser photorefractive keratectomy for hyperopia: 7.5-year follow-up. J Cataract Refract Surg 2005;31(6):1104-13.
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BRIEFLY
  • FIRST OPHTHALMIC NON-STEROIDAL ANTI-INFLAMMATORY PRODRUG EARNS FDA APPROVAL. After a priority six-month review, the FDA has approved a new drug application for Alcon’s Nevanac (nepafenac ophthalmic suspension, 0.1%) for the treatment of pain and inflammation associated with cataract surgery. Nevanac contains a novel prodrug that rapidly penetrates ocular tissues and is target-specific; it is the first ophthalmic non-steroidal anti-inflammatory prodrug to receive FDA approval. The approval was based on results of two multi-center placebo-controlled studies, involving more than 680 patients, in which the drug was dosed three times per day, beginning one day before cataract surgery, continuing on the day of surgery and for 14 days postoperatively. Patients were evaluated at baseline and at one, three, seven and 14 days after surgery. Those treated with Nevanac had significantly less ocular pain and inflammation in the early postop period through the end of treatment. More than 80 percent of patients treated with Nevanac suspension were pain-free the day after surgery, compared to less than 50 percent in the placebo group. Following two weeks of treatment with Nevanac, about 95 percent of patients were pain-free, compared to 45 percent of patients in the placebo group, and 91 percent of patients treated with Nevanac had no clinically significant inflammation, compared to about 47 percent of patients in the placebo group. No unexpected adverse events were reported. Alcon expects Nevanac to be commercially available within the next several weeks.
  • OSI AND EYETECH PHARMACEUTICALS SIGN MERGER AGREEMENT. OSI Pharmaceuticals, Inc. and Eyetech Pharmaceuticals, Inc. have entered into a definitive merger agreement whereby OSI will acquire Eyetech, a biopharmaceutical company focusing on development and commercialization of novel therapeutics to treat eye diseases. Under the agreement, OSI will acquire all outstanding shares of Eyetech common stock in a combination of cash and OSI common stock for approximately $935 million. The acquisition is subject to a number of closing conditions, including Eyetech stockholder approval and regulatory approvals. The merged company will be comprised of three business units: oncology, eye diseases and diabetes. The companies expect to complete the transaction by the end of 2005.
  • OPTOS FORMS STRATEGIC ALLIANCE WITH EYEMAGINATIONS. Ophthalmic retinal imaging company Optos, Inc. has formed a strategic alliance with interactive design and multimedia firm Eyemaginations, Inc. The partnership aims to capitalize on the strengths of both companies to focus on eyecare patient education materials. The first project for Eyemaginations and Optos is an educational animated video explaining the Optomap Retinal Exam, which will be incorporated into Eyemaginations’ software, the 3D-Eye Office. The animation helps eyecare practitioners and their staff members clarify procedures and educate patients about key components of their ocular health. For more information, go to www.eyemaginations.com or www.optos.com.
  • FCI INTRODUCES LONG-TERM ABSORBABLE PUNCTAL PLUG. FCI Ophthalmics has introduced the ProLong Plug, a long-term punctal plug to supplement the company"s line of short-term collagen plugs and non-dissolvable Ready-Set Punctum Plugs. ProLong plugs are designed to provide patient comfort from dry eye components of various ocular surface diseases for three months or longer. The product is effective and economical for transient dry eye symptoms following surgery and useful for post-op dry-eye management of LASIK patients. The ProLong plug is composed of an absorbable copolymer material and comes in three sizes: 0.3mm, 0.4mm and 0.5mm diameters. Each is 2.0mm long. The plugs are packaged in same sizes or in a variety pack of all three sizes. For more information, go to www.fci-ophthalmics.com or call 800-932-4202.


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