Bausch & Lomb and Control Delivery Systems Announce Results of First Phase III Clinical Trial of Envision TD Ophthalmic Implant for Treatment of Diabetic Macular Edema.

Business Editors & Medical Writers

ROCHESTER, N.Y. & WATERTOWN, Mass.--(BUSINESS WIRE)--June 6, 2002

Bausch & Lomb (NYSE: BOL):

- Statistically Significant Reduction in Macular Edema

- Statistically Significant Reduction in Severity of Diabetic Retinopathy

- Greater Proportion of Patients with Improved or Stabilized Visual Acuity

- No Difference in Incidence of Serious Adverse Events Versus Standard of Care

Bausch & Lomb (NYSE: BOL) and Control Delivery Systems (CDS) today announced results of the intent-to-treat analysis of data from the first phase III randomized, controlled and masked clinical trial designed to assess the safety and efficacy of an ophthalmic implant, based on Envision TD(TM) technology, for the treatment of diabetic macular edema (DME).

Compared to standard of care, patients receiving the implant showed a reduction in macular edema and in the severity of their diabetic retinopathy, and more patients with the implant showed improved or stabilized visual acuity. There was no difference in serious adverse events between implant-treated patients and those receiving standard of care.

The implant used in this study is a tiny drug reservoir implanted into the back of the eye. The implant utilizes proprietary Envision TD technology to enable 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.

In this multi-center trial, 80 patients were randomized to receive standard of care (macular grid laser or observation) or either a 0.5 mg or a 2 mg implant. The 2 mg dose was discontinued early in the DME trial because data from other studies did not suggest a therapeutic advantage for the 2 mg over the 0.5 mg dose.

The primary endpoint for this trial was change in macular edema at six months compared to baseline, as assessed by retinal thickening. Patients receiving the 0.5 mg implant showed statistically significant improvement in macular edema compared to those receiving standard of care (p = 0.03). Further, patients receiving the 0.5 mg implant experienced a greater improvement in the severity of their diabetic retinopathy compared to those treated with standard of care (p = 0.01). Over 80% of these patients also had improved or stable visual acuity compared to 50% treated with standard of care (p is less than 0.01).

"To have achieved statistical significance in the reduction of macular edema, the primary endpoint, as well as a reduction in the severity of diabetic retinopathy is very important from a clinical perspective," said Dr. Michael Ip of the University of Wisconsin, one of the investigators in the trial. "Compared to the standard of care, there was also an improvement in visual acuity, which was statistically significant at 5 letters and strongly trended toward significance at 10 letters, even though the study was not designed or powered to demonstrate this."

Overall, the incidence of serious ocular adverse events was essentially the same in both the standard of care group (18%) and the 0.5 mg implant group (15%). These events included cataracts, vitreous hemorrhage, retinal neovascularization and ocular hypertension, which were anticipated given the nature of the disease and the type of drug used. No patients required implant removal or withdrew from the study due to an adverse event. All instances of elevated IOP requiring treatment were successfully treated with eye drops.

The United States Food and Drug Administration has granted fast track designation for this implant. The data from this trial, together with the results of a second ongoing 6-month pivotal trial, will serve as the basis for a new drug application expected to be filed in 2003 under the FDA's accelerated approval process. The second trial will include approximately 180 patients and is expected to be fully enrolled in the third quarter of 2002. Under the fast track accelerated approval process, post-approval studies are planned to correlate the primary endpoint of this study with visual acuity over 3 years.

"We are very pleased with these results - the first data from a randomized clinical trial designed to evaluate the safety and effectiveness of this implant for DME, which is an important indication in our comprehensive development program based on the Envision TD ophthalmic drug delivery technology. These results certainly reinforce our confidence in this technology platform and our commitment to pursue its potential by providing the focus and resources needed to bring it to market," said Ronald L. Zarrella, chairman and CEO of Bausch & Lomb.

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. This data may be used to seek supplemental approvals for label extensions. Complete findings from this trial will be presented by the investigators at the Retina Congress 2002 in September and will be submitted for publication in an appropriate peer-reviewed journal.

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 disease progression.

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. For additional information on CDS, access the company's Web site at: www.controldelivery.com.

Envision TD(TM) is a trademark 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.