New PrONTO Data: Vision Gains Sustained
OCT Testing a Key in Timing Retreatment.
■ New 2-year clinical data for the important PrONTO study in which patients with wet AMD received Lucentis injections on a schedule determined by OCT testing were released at the recent Retinal Physician Symposium. The data showed that, with regular OCT monitoring, patients could sustain vision gains with an average of 5 Lucentis injections a year, as compared to the currently recommended schedule of monthly injections.
PrONTO, which was undertaken by Philip Rosenfeld, MD, PhD, of Bascom Palmer Eye Institute with the cooperation of Lucentis developer Genentech, is a single-center, uncontrolled, investigator-sponsored study that evaluated OCT-guided variable-dosing of Lucentis (0.5 mg) in 40 patients with subfoveal choroidal neovascularization due to AMD.
The 2-year data showed that OCT-guided variable-dosing of Lucentis resulted in visual acuity gains consistent with the pivotal phase 3 clinical trials MARINA and ANCHOR, but with less frequent dosing.
Thirty-seven of the 40 patients completed the 24-month follow-up, with the 3 discontinuations unrelated to treatment. In addition, an amendment to modify the OCT retreatment criteria was implemented in the second year to include any qualitative changes in the appearance of OCT images. The earliest crossover to the new protocol was at month 17. Five patients had completed the study by the time the amendment was implemented.
At 2 years, patients treated with Lucentis averaged 5 injections per year and 9.9 total injections over 2 years. Seventy-eight percent of patients treated with Lucentis maintained vision (gained 0 or more letters from baseline). Forty-three percent of patients improved vision (gained 15 or more letters from baseline) at 2 years. Patients experienced a mean reduction in central retinal thickness of 215 μm and a mean improvement in visual acuity of 10.7 letters at 2 years.
The use of OCT monitoring to determine Lucentis retreatment schedules has generated great interest in the retina community, but researchers agree that larger controlled studies are needed to validate this approach.
|■ B&L to be acquired. Bausch & Lomb has entered into a merger agreement with affiliates of Warburg Pincus, a global private equity firm, to be taken private in a transaction valued at approximately $4.5 billion, including approximately $830 million of debt. However, B&L has the right to entertain higher offers until July 5. If a better offer materializes, B&L must pay Warburg Pincus a $40 million break-up fee.|
On May 24, Advanced Medical Optics said it was exploring the possibility of making a higher offer.
Warburg Pincus plans to acquire all of the outstanding shares of Bausch & Lomb common stock for $65 per share in cash. Bausch & Lomb's board of directors has recommended that company shareholders approve the merger.
Ronald L. Zarrella, chairman and CEO of Bausch & Lomb, said, "As a private company, Bausch & Lomb will have greater flexibility to focus on our long-term strategic direction to be a global leader in providing innovative and technologically advanced eye health products to eyecare professionals and consumers."
In related news, Bausch & Lomb announced the formation of a focused team of retinal products representatives for the US market who will provide sales support to surgeons for the company's extensive portfolio of retina products.
This dedicated retina sales team will support the Millennium Microsurgical System and associated products, Storz vitreoretinal instruments, Retisert and Vitrasert sustained drug-delivery implants, and PreserVision eye vitamin and mineral supplement. The team's efforts will be enhanced by vitreoretinal specialists who will provide additional overlapping technical and clinical expertise to B&L vitreoretinal customers.