Clinical Studies Show Efficacy and Safety of Norwood Eyecare Epikeratome.

MELBOURNE, Australia -- Norwood Abbey Limited (OTC:NABYF) (ASX:NAL):

Key Points:

--Study in short-sighted patients shows Epi-LASIK is a safe and effective treatment

--Greater return of corneal sensitivity with Epi-LASIK procedure than with LASIK 

--Study results presented at major U.S. Ophthalmology conference

Norwood Abbey Limited (OTC:NABYF) (ASX:NAL) subsidiary, Norwood EyeCare, the innovative ophthalmic devices company announced results of three clinical studies this week at the American Society of Cataract and Refractive Surgery (ASCRS) meeting, held April 15-20 at the Washington Convention Center (Washington, D.C). All three studies employed Norwood EyeCare's Epikeratome for Epi-LASIK. The study results -- including the evaluation of visual acuity, pain, haze and corneal sensitivity -- suggest that Epi-LASIK with the Norwood EyeCare Epikeratome is a safe and effective modality for the treatment of low and moderate myopia (short-sightedness), based on a one-year follow up.

One study compared patients who underwent Epi-LASIK and LASIK on corneal sensitivity. Reduced corneal sensitivity is associated with dry eye and also with a decrease in the blink reflex, impediment of epithelial healing, a compromised rate of epithelial cell mitosis, decrease in tear flow, and with the onset of keratitis. The study found that corneal sensitivity in Epi-LASIK patients was only slightly decreased during the first month and was fully recovered by the third postoperative month, while after LASIK it was still decreased as late as the sixth postoperative month.

"The refractive community has already enthusiastically accepted Epi-LASIK. Clinical research like these studies, as well as histopathological data, are contributing to a substantial and growing body of evidence about the benefits of Epi-LASIK in preserving tissue integrity," explained Ioannis Pallikaris, M.D., Ph.D., President of the European Society of Cataract and Refractive Surgeons and the founder and director of the Vardinoyannion Eye Institute of the University of Crete, Greece, where two of the studies were conducted. "This is especially important for conditions like dry eye, a common complication of LASIK."

Background details of the Epi-LASIK Studies

Comparison of Epi-LASIK and LASIK on Corneal Sensitivity

A prospective study by Maria I. Kalyvianaki and Vikentia J. Katsanevaki, M.D., Ph.D., of the Vardinoyannion Eye Institute of the University of Crete, Greece ("Comparison of Corneal Sensitivity After Myopic Epi-LASIK and LASIK") compared the effects of both Epi-LASIK and LASIK on corneal sensitivity. A total of 79 eyes of 52 patients underwent Epi-LASIK for the treatment of myopia and myopic astigmatism with the Norwood Epikeratome, while a total of 74 eyes of 38 patients underwent LASIK. Patients in the two groups were matched for age and attempted correction. Corneal sensitivity was tested preoperatively and at 1, 3, 6 months postoperatively using the Cochet-Bonnet esthesiometer.

Corneal sensitivity decreased more after LASIK than after Epi-LASIK at all postoperative intervals. In the Epi-LASIK group mean corneal sensitivity decreased from 5.57+/-0.34 (range 4 to 6) preoperatively to 5.18+/-0.78 (range 3 to 6) 1-month postoperatively (p=0.007). Three months postoperatively it had already recovered its preoperative values. After LASIK corneal sensitivity was decreased from 5.64+/-0.46 cm (range 5 to 6) preoperatively to 5.01+/-0.25 (4.5 to 6) at one, 5.45+/-0.53 (4.5 to 6) at three and 5.19+/-0.75 (4 to 6) at six postoperative months. The differences in corneal sensitivity after LASIK and Epi-LASIK were statistical significant at 3 and 6 months (p less than 0.05).

Epi-LASIK in Treatment of Low to Moderate Myopia

The second study, by Dr. Katsanevaki, evaluated the efficacy and safety of Epi-LASIK for the treatment of low myopia and myopic astigmatism, using the Norwood EyeCare Epikeratome in 95 eyes of 65 patients ("Epi-LASIK: Clinical Results of an Advanced Surface-Ablation Procedure"). Epithelial separation was successfully performed in all 95 eyes. The epithelial healing was completed within 4.85+/-0.87 days, a range of 3 to 5 days.

The mean log MAR UCVA on the day of re-epithelization was 0.23+/- 0.11. The spherical equivalent was -0.25D+/- 0.14D at one-month postoperative interval, -0.14+/-0.43 at three months and -0.28+/-0.5 at six months postoperatively. A total of 46% of the treated eyes gained one to two lines of BSCVA at six months after the operation. All Epi-LASIK treated eyes had clear corneas (92%) or trace haze (8%) by the sixth postoperative month.

The third study, by Effacing Coskunseven, M.D., of the Dunya Eye Hospital, Istanbul, Turkey, investigated the efficacy and safety of Epi-LASIK in the treatment of low to moderate myopic patients with a follow up of 1 year ("Epi-LASIK for Low Myopia: 1-Year Results in 92 Eyes"). A questionnaire was given to the patients to assess the discomfort level postoperatively; 80% of patients did not report any pain or major discomfort. The mean UCVA was preoperatively 0.14 +/- 0.17 and postoperatively (at 1 year) 0.91 +/- 0.27. Preoperatively, BCVA was 0.92 +/- 0.14 and postoperatively 0.93 +/- 0.17. MSEMR was preoperatively -3.92 +/- 1.64 and postoperatively -0.43 +/- 0.67 D.

U.S. Prospective Study

Norwood EyeCare recently announced the initiation of a 3-month multi-center study of post-operative comfort, visual recovery and wave-front guided custom ablation with its Centurion SES(TM) Epikeratome with EpiEdge(TM) for Epi-LASIK in surgical treatment of myopia. Marguerite B. McDonald, M.D., F.A.C.S., is the principal investigator and medical monitor for the study. Daniel D. Durrie, M.D., and Lee Shahinian, M.D., are clinical investigators.

"Epi-LASIK and wavefront diagnostics address two other key complications, such as stromal flap complications and higher order aberrations associated with current refractive laser procedures," explained Dr. McDonald, clinical professor of ophthalmology at Tulane University and former president of the American Society of Cataract and Refractive Surgery. "In this exciting study, we will examine how the coupling of the two technologies may impact visual outcomes."

For further information on Norwood EyeCare visit www.norwoodeyecare.com.