Bausch & Lomb Acquired by Private Investors
On May 15, 2007, Bausch & Lomb (Rochester, NY) reported that Warburg Pincus LLC, a multinational private equity firm (New York, NY), acquired the eye care company for an estimated $4.5 billion. Under the terms of the agreement, Warburg Pincus will pay $65 in cash for each of Bausch & Lomb’s outstanding shares, and assume an existing debt of $83 million.
According to a news release from Bausch & Lomb, the company is free to solicit superior proposals from third parties and to respond to unsolicited proposals for the next 50 calendar days. If the company finalizes an another agreement during this period, it will pay Warburg Pincus a $40 million break-up fee.
“After extensive negotiations and careful and thorough analysis, together with our independent advisors, the Special Committee and our board have unanimously endorsed this transaction as in the best interest of the company and our shareholders,” said William H. Waltrip, lead director and chairman of the Special Committee of Bausch & Lomb’s Board of Directors, in a Marketwatch news release. “We are pleased that this transaction appropriately recognizes the value of Bausch & Lomb’s highly respected brand and innovative products in the eye care industry, while providing our shareholders with an immediate and substantial cash premium for their investment.”1
News of the buyout boosted the value of shares in Bausch & Lomb by 8.5% from $61.50 at closing on May 15 to $66.74 in morning trading on May 16.
1. Bausch & Lomb agrees to $4.5 billion buyout. Available at: http://www.marketwatch.com/news/story/bausch—lomb-agrees-45/story.aspx?guid=%7B07965E21-FC1F-43F6-8B65-B65F870A17AE%7D. Accessed May 16, 2007.
MLT Provides Adequate IOP Reduction Without Scarring Tissue
Micropulse laser trabeculoplasty (MLT) is a new, noncoagulative laser therapy for reducing IOP in eyes with primary open-angle glaucoma and ocular hypertension. This treatment reportedly opens the trabecular meshwork without producing clinically observable thermal effects or scarring.1
The Iridex IQ 810 infrared laser.
The latest laser developed to perform MLT is the IQ 810 (Iridex Corp., Mountain View, CA). The FDA has also approved the laser for glaucoma procedures such as laser trabeculoplasty, transscleral cyclophotocoagulation, and iridotomy as well as for retinal photocoagulation.
MLT was developed using a micropulsed laser emission mode, which controls the thermal effects produced by the laser, reduces the formation of burns, limits thermal spread, and prevents collateral damage during subthreshold retinal treatments. Each pulse has a short “on” time (300 microseconds) to minimize the thermal spread, followed by a long “off” time (1,700 microseconds) to favor thermal relaxation toward the baseline temperature before the next micropulse occurs. As a result, MLT produces only clinically invisible photothermal effects in the trabecular meshwork. MLT is performed by placing 60 to 65 confluent laser applications over a180º angle using 2 W of power over a 300-µm–diameter spot.
In an email to Glaucoma Today, Giorgio Dorin, Director of Clinical Applications Development at Iridex Corporation, wrote that MLT opens the trabecular meshwork by creating a “time-temperature-history of repetitive, sublethal thermal rises in all trabecular meshwork cells, in the superficial and in the deeper juxtacanalicular layers to create cellular injury.” Mr. Dorin said that this process is important, because it stimulates the cellular cascade believed to be crucial for reducing IOP while maintaining the integrity of the trabecular meshwork. Furthermore, MLT is reportedly painless, has no associated complications, and is easy to perform.1
1. Fea AM, Bosone A, Rolle T, et al. Micropulsed laser trabeculoplasty: a pilot study. Paper presented at: The International Glaucoma Symposium; March 30, 2007; Athens, Greece.
FDA Denies NDA for Combination Agent
Last week, the FDA issued a not approvable letter to Ista Pharmaceuticals, Inc. (Irvine, CA), for T-Pred (prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension), a combination drug indicated for the treatment of “inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists.”1
According to the company, a multicenter, randomized, double-blind, phase 3 study completed in 2005 showed that T-Pred’s efficacy was comparable to that of other combination agents approved for similar ocular conditions. The FDA concluded, however, that the clinical data did not merit the drug’s approval. The agency specifically cited a lack of bioequivalence between the drug’s steroidal and anti-infective components and Ista Pharmaceuticals’ previously approved standalone formulations for those respective indications (PredForte and Tobrex).
1. Ista provides regulatory update on T-Pred NDA Filing. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=121179&p=irol-newsArticle&ID=995793&highlight=. Accessed May 7, 2007.
Experts Report Consensus on IOP Fluctuation
According to a poster presented during the ARVO Annual Meeting in Fort Lauderdale, Florida, documenting long-term fluctuations in IOP may provide valuable information about the progression of glaucoma that is not available by measuring the mean reduction in IOP alone.1
Investigators retrospectively analyzed data from the masked-evaluator, parallel-group XLT study, in which patients with open-angle glaucoma or ocular hypertension were randomized to receive Xalatan (latanoprost; Pfizer Ophthalmics, New York, NY [n = 136]), Lumigan (bimatoprost; Allergan, Inc., Irvine, CA [n = 136]), or Travatan (travoprost; Alcon Laboratories, Inc., Fort Worth, TX [n = 138]) for 12 weeks. At baseline, 64% of the 410 patients’ IOPs fluctuated by more than 6 mm Hg over four time points (8:00 AM, 12 noon, 4:00 PM, and 8:00 PM). The mean pretreatment range of IOP fluctuations was similar in all three groups (7.5 to 7.8 mm Hg).
After 12 weeks of treatment, the percentage of patients experiencing more than 6 mm Hg of diurnal fluctuation decreased to 21%, 28%, and 36% in the latanoprost, bimatoprost, and travoprost groups, respectively.
The results of this study are important for several reasons, remarked George A. Cioffi, MD, Chair of the IOP Consensus Panel and Director of Glaucoma Service, Devers Eye Institute for Legacy Health in Portland, Oregon, in a press release from Pfizer Ophthalmics. “Up until now, there has been much debate about the significance of long-term IOP fluctuation, and there is still conflicting evidence regarding the relevance of fluctuation in the clinical care of glaucoma patients,” he said.2
Using a modified Delphi process, Dr. Cioffi and his colleagues determined that “the reduction of IOP fluctuation should include reduction in the IOP peak and that care of patients with advancing glaucoma should include measurement of long-term IOP fluctuation.”3
1. Hwang L-J, Varma R, Grunden JW. Long-term intraocular pressure (IOP) fluctuation. An alternative parameter for assessing IOP control in clinical trials. Poster presented at: The ARVO Annual Meeting; May 7, 2007; Fort Lauderdale, FL.
2. Glaucoma experts determine that reducing intraocular pressure fluctuation plays a key role in glaucoma treatment. Available at: http://www.medicalnewstoday.com/medicalnews.php?newsid=70506. Accessed May 14, 2007.
3. Cioffi GA, Lee PP, Sultan MB, et al. Assessing the measurement and value of IOP changes in glaucoma using modified Delphi process with glaucoma experts. Poster presented at: The ARVO Annual Meeting; May 7, 2007; Fort Lauderdale, FL.
Few Complications Reported With ECP
A prospective study that followed 5,824 glaucoma patients for a mean of 5.2 years after they were treated with endoscopic cyclophotocoagulation (ECP) showed a low incidence of long-term complications.1
Few eyes developed serious long-term complications such as choroidal hemorrhage (n = 5; 0.09%), hypotony/phthisis (n = 7; 0.12%), or progression to no light perception (n = 7; 0.12%). These problems were associated only with neovascular glaucoma or intraoperative hypotony in single-chamber eyes with refractive glaucoma.
Jon-Marc Weston, MD, of Roseburg, Oregon, presented the results of the study on behalf of Robert J. Noecker, MD, of Pittsburgh during the ASCRS Symposium on Cataract, IOL and Refractive Surgery in San Diego. He noted that early complications, including postoperative IOP spikes, hyphema or vitreous hemorrhage, and serous choroidal effusion occurred in 14.5%, 3.8%, and 0.36% of patients, respectively, regardless of the mechanism of glaucoma. ECP, a cyclodestructive procedure, appeared to be associated with the development of cataracts in 24.5% (261 of 1,066) of eyes, however.
Dr. Weston concluded, “The safety of ECP compares favorably to the historical data associated with trabeculectomy and tube implantation and far surpasses that of transscleral cyclophotocoagulation.”
1. Noecker R. Complications of endoscopic cyclophotocoagulation: ECP Collaborative Study Group. Paper presented at: The ASCRS Symposium on Cataract, IOL and Refractive Surgery; May 1, 2007; San Diego, CA.
Healthcare Facilities Receive Endowments
The Oregon Health Science University’s Casey Eye Institute and the Legacy Good Samaritan Hospital’s Devers Eye Institute (both in Portland, Oregon) each received a $1 million endowment from the Schnitzer/Novack Foundation to enhance the level of care that the centers offer. The pledges will fund the Thelma and Gilbert Schnitzer Professorship for Ophthalmic Research (Casey) and establish the Thelma and Gilbert Schnitzer Comprehensive Glaucoma Eye Center (Devers).
The Indiana University School of Medicine in Indianapolis plans to use $30 million donated by local philanthropists Eugene and Marilyn Glick to build a new 40,000-square-foot, three-story research space on the school’s campus. According to a news release from the university, $20 million of the gift will be used to build the new facility, and the remaining $10 million will endow ongoing research into debilitating eye diseases such as glaucoma, cataract, and diabetic retinopathy.
Race Does Not Affect Response to Topical Beta Blockers
A multivariate analysis of results from the Ocular Hypertension Treatment Study suggests that race does not predict the efficacy of a particular class of topical IOP-lowering medications.1
During the Ocular Hypertension Treatment Study, patients were randomized to treatment with topical beta adrenergic antagonists or prostaglandin analogs. Twenty-five percent of the patients in the study identified themselves as black versus white.
Patients from both racial groups showed similar changes from their mean baseline IOP after 6 weeks of treatment with beta adrenergic antagonists. Black patients appeared to achieve a greater decrease in IOP with prostaglandin analogs than white patients (30.3% versus 24.8%), but the difference was not statistically significant. Stepwise, multiple regression analyses of patients’ responses to prostaglandin analogs showed that central corneal thickness and baseline IOP were more strongly associated with the observed differences than race.
Based on the results of this study, the investigators concluded that “clinicians should consider factors other than race such as medical history, dosing schedules and possible adverse effects when prescribing hypotensive medication for patients.”
1. Mansberger SL, Hughes BA, Gordon MO, et al. Comparison of initial intraocular pressure response with topical beta-adrenergic antagonists and prostaglandin analogues in African American and white individuals in the Ocular Hypertension Treatment Study. Arch Ophthalmol. 2007;125:454-459.
Proposal Would Impose Financial Limits on FDA Committee Members
Under current FDA regulations, only physicians who hold more than $100,000 of stock in a pharmaceutical or device company are excluded from voting for the approval of that company’s products. In March 2007, however, the FDA issued a draft resolution that, if implemented, will lower the financial threshold by 50%, a change that may affect many physicians’ eligibility to serve on product advisory boards.
According to Randall Lutter, PhD, the FDA’s acting deputy commissioner for policy, the new guidelines are designed to reduce conflicts of interest that could unduly influence the approval process. The new regulations would prevent individuals whose financial interest in a company exceeds $50,000, where “financial interest means the potential for gain or loss to a person … as a result of the government’s action on a particular topic,”1 from serving on approval committees.
“The FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” said Dr. Lutter in an FDA news release. “The [March 21] draft guidance document should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process.”
Setting the cap on committee members’ financial interest at $50,000 would prevent a lot of qualified ophthalmologists from participating in the approval process, said Thomas E. Bournias, MD, Director of the Northwestern Ophthalmic Institute and Assistant Professor of Clinical Ophthalmology at Northwestern University Medical School in Chicago, in an interview with Glaucoma Today.
“We ophthalmologists feel that our representation with the FDA has been poor for many years, and this change would only put us at a further disadvantage,” he said. “If ophthalmologists are barred from committees by an overly rigid financial rule, the approval process will be deprived of much-needed clinical expertise.”
Chris A. Johnson, PhD, Levitt Visiting Professor in the Department of Ophthalmology at the University of Iowa in Iowa City, is more optimistic about the proposed change in the FDA’s policy. “Over the years, I have been impressed with the fairness and thoroughness of the evaluation of new ophthalmic products,” he wrote in an email to GToday. “I think that setting a lower cap on physicians’ financial interest in companies may affect some ophthalmologists, but full disclosure and conflict of interest are important considerations.” It would be unrealistic to assume that companies that have a vested interest in a drug’s or device’s approval would not put their best foot forward, he stated. “With appropriate checks and balances in place, the approval process can be handled on a satisfactory basis,” Dr. Johnson added.
1. FDA Web site. FDA proposes new, tougher procedures for membership on advisory committees. Available at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01591.html. Accessed May 14, 2007.