Bausch & Lomb: Analysis of Six-Month Trial of Fluocinolone Acetonide Implant in the Treatment of Diabetic Macular Edema Presented at Retina Congress 2002.

Business Editors/Health & Medical Writers

SAN FRANCISCO--(BUSINESS WIRE)--Sept. 30, 2002

Results from an 80-patient Phase III clinical trial using an intravitreal fluocinolone acetonide implant for the treatment of diabetic macular edema were discussed today at the Retina Congress 2002, the combined annual meeting of the Retina Society and the Vitreous Society.

The findings presented today by Dr. P. Andrew Pearson, chairman of the Department of Ophthalmology at the University of Kentucky Medical School and lead investigator for the trial, detail the statistically significant reduction in macular edema and in the severity of diabetic retinopathy and other results previously reported for the trial. Bausch & Lomb (NYSE:BOL) and its development partner, Control Delivery Systems, sponsored the study.

In June of this year, the study sponsors reported the major findings of this trial, which demonstrated that compared to the standard of care (macular grid laser surgery or observation), patients receiving the implant showed a statistically significant reduction in both macular edema and in the severity of their diabetic retinopathy, as assessed by retinal thickening; a greater proportion of patients with the implant showed improved or stabilized visual acuity; and there was no difference in the incidence of serious adverse events.

The implant used in this study is a tiny drug reservoir inserted into the back of the eye. The implant uses proprietary Envision TD(TM) technology enabling the delivery of sustained and consistent levels of the drug fluocinolone acetonide directly to the affected area of the eye for up to three years.

Notable results of the clinical trial discussed by Dr. Pearson today are as follows:

Macular Edema/Retinal Thickening

Edema is caused by a build-up of fluid in the retina that can affect the photoreceptor nerve cells lining the back of the eye, resulting in impaired vision. The primary endpoint of this trial was change in macular edema between the standard of care and implant groups at six months compared to baseline, as evidenced by retinal thickening. As previously reported, patients receiving the 0.5 mg implant showed statistically significant improvement in macular edema compared to those receiving standard of care (p=0.03). The analysis reported today further showed that 36.8% of the patients treated with the 0.5 mg implant vs. 7.7% treated with the standard of care improved more than two grades as measured by independently evaluated fundus photographs. Further, a "fellow eye comparison" (comparing treated and untreated eyes in the same patient) showed a statistically significant difference in retinal thickness for the implanted eye vs. the fellow eye (p Less than 0.003); no significant difference was observed in the standard of care group.

Diabetic Retinopathy

As previously reported, patients receiving the 0.5 mg implant experienced a statistically significant improvement in the severity of their diabetic retinopathy compared to those treated with standard of care (p=0.01). Dr. Pearson reported today that 36.9% of patients treated with the 0.5 mg implant demonstrated one unit or greater improvement in their retinopathy severity scores as compared to 14.8% in the standard of care group. A fellow eye comparison showed statistically significant reduction in retinopathy severity scores in the eye receiving the implant (p=0.002). The difference between treated and untreated eyes in the standard of care group was not statistically significant.

Visual Acuity

As previously reported, over 80% of patients treated with the 0.5 mg implant had improved or stable visual acuity compared to 50% of those treated with standard of care (p Less than 0.01). Dr. Pearson noted that this improvement reached statistical significance at five letters, and strongly trended toward significance at ten letters, even though this study was neither designed nor powered to show improvement in visual acuity. Further, a fellow eye comparison showed that over 80% of eyes treated with the implant had improved or stabilized visual acuity compared with less than half of fellow eyes not receiving an implant.

Adverse Events

As previously reported, the overall incidence of serious ocular adverse events at six months was essentially the same in both the standard of care group (18%) and the 0.5 mg implant group (15%). These events, which were anticipated given the nature of the disease and the type of drug used, included cataracts, vitreous hemorrhage and ocular hypertension. As expected, the proportion of patients with increased intraocular pressure (30mm Hg or greater) was higher in the 0.5mg group (12.2%) than in the standard of care group (0%). All incidences of elevated IOP requiring treatment were successfully managed with anti-hypertensive medication. In addition, cataract progression at six months was 0.0% in the standard of care group vs. 17.1% in the 0.5 mg implant group. No patients required implant removal or withdrew from the study due to an adverse event. Dr. Pearson noted in his remarks that given the nature of DME, the drug used and demographic characteristics of the population being studied (e.g. mean age of 64 years), the incidence of these adverse events in the implant group is likely to increase as patients are followed for longer periods of time.

Patients in this trial will be followed for an additional 3.5 years to continue to monitor the safety of this implant over an extended period of time.

Bausch & Lomb has previously announced that a second trial for diabetic macular edema, involving approximately 200 patients at 23 centers in the United States, has been fully enrolled and the outcomes of that trial should be available in the first quarter of 2003. Two Phase III trials investigating the use of similar implants in the treatment of posterior uveitis are also being conducted, and Phase II trials investigating the use of similar implants in the treatment of age-related macular degeneration are underway.

About Diabetic Macular Edema

Diabetic macular edema, or DME, is a complication of diabetes caused by changes in the blood vessels of the retina, the light sensing nerve layer in the back of the eye. These changes can cause swelling, which is known as edema. When this swelling affects the most sensitive portion of the retina, the macula, vision loss and even blindness may occur. More than 750,000 eyes in the United States and over 2.5 million eyes worldwide are afflicted with DME of sufficient severity to require treatment. Current treatments are limited and can generally only temporarily reverse vision loss and slow progression of the disease.

About Bausch & Lomb

Bausch & Lomb is a preeminent technology-based healthcare company for the eye, helping consumers see, look and feel better through innovative technology. Its core businesses include soft and rigid gas permeable contact lenses and lens care products, ophthalmic surgical and pharmaceutical products. Founded in 1853 in Rochester, New York, where it continues to have its headquarters, the company had revenues of approximately $1.7 billion in 2001. Bausch & Lomb employs approximately 12,000 people in more than 50 countries. Its products are available in more than 100 countries around the world. Additional information about the company may be found at www.bausch.com.

About Control Delivery Systems

Control Delivery Systems, Inc. develops innovative, sustained-release, drug-delivery products to treat severe and chronic diseases that currently have limited or no effective treatment options. CDS' proprietary products are designed to deliver an appropriate quantity of approved drugs to a target site at a controlled rate for a predetermined period ranging from days to years, virtually eliminating the variations in drug concentration and adverse systemic side effects characteristic of most traditional drug treatments. CDS is seeking to develop treatments for potentially blinding eye diseases, brain tumors, post-surgical pain and osteoarthritis. CDS, a privately held company, is headquartered in Watertown, MA. Additional information about CDS may be found at www.controldelivery.com.

Envision TD(TM) and Retisert(TM) are trademarks of Bausch & Lomb Incorporated Copyright Bausch & Lomb.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Some statements contained in this press release are forward-looking and involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially are the following: product development, enrollment and completion of clinical trials, regulatory approvals, product introductions, and other risk factors identified in Bausch & Lomb's SEC filings including its most recent Form 10-K and in CDS' SEC filings. Neither Bausch & Lomb nor CDS undertakes to publicly update or revise any forward-looking statements.