At Press Time

Procedure Regenerates Damaged Corneas

A 10-patient trial using biosynthetic collagen is encouraging.

■ Implanting a sliver of biosynthetic collagen into a damaged corneal layer has shown early promise in restoring vision in humans. This procedure was used on 10 selected patients in Sweden, researchers reported in the journal Science Translational Medicine.

The effort is essentially an attempt to rebuild a cornea by introducing specially-treated human collagen into the eye as a form of donor tissue and inducing the patient's cornea to incorporate it.

"We're trying to regenerate the cornea from within," May Griffith, MD, told the Associated Press. Dr. Griffith is a senior scientist at the Ottawa Hospital Research Institute in Canada and a professor of regenerative medicine at Linkoping University in Sweden.

The procedure involved researchers first taking human collagen grown in yeast and then molding it into the shape of a contact lens. The collagen was then implanted in the eye to replace damaged tissue.

According to the Associated Press report, "Soon, cells that line a healthy cornea started growing in the collagen. Tear production normalized, and even corneal nerves regrew, something researchers could test by measuring sensitivity. There was no rejection and patients didn't need immune-suppressing medication. Two years later, six of the patients had significantly improved vision with glasses and two were no worse."

Several of the patients were later fitted with contact lenses and saw as well as patients in a control group who had undergone a standard corneal transplant.

The researchers cautioned that larger studies are needed and that none of the 10 patients required a full-thickness transplant.

Eyegenix, the ophthalmic division of Cellular Bioengineering, Inc., has the exclusive worldwide commercial corneal transplantation rights to this biosynthetic material.

Four Ophthalmologists Seek National Office

Three pursuing House seats; one in Senate race.

By Jerry Helzner, Senior Editor

■ While Rand Paul, MD, has been receiving national attention as the Republican and Tea Party frontrunner for the US Senate seat in Kentucky, three other ophthalmologists are also on the Republican ticket for seats in the House of Representatives.

Donna Campbell, MD, is opposing incumbent Dem. Lloyd Doggett for a house seat that represents Austin, Tex. She is a graduate of Texas Tech University Medical School and completed her ophthalmology residency at the University of Texas, Houston. She is board-certified in oph thalmology and emergency medicine.

Marianette Miller-Meeks, MD, is running against incumbent Dem. Dave Loebsack in Iowa's second district. Dr. Miller-Meeks, a retired Army officer, attended medical school at the Univer sity of Texas and completed her ophthalmology residency at University of Iowa. She was the first female faculty member in the University's ophthalmology department.

Nan Hayworth, MD, is running against Dem. John Hall, the incumbent candidate, in the 19th district of New York. Dr. Hayworth, who retired from practice from the Mount Kisco Medical Group in 2005, is a graduate of the Cornell University Medical College.

Meanwhile, Dr. Paul has been maintaining a significant eight- to 10-point lead in the polls against his Democrat opponent, Kentucky Attorney General Jack Conway.

B+L to Compete in Injectable Miotics

Novartis/Alcon merger leads to a new supplier.

By Jerry Helzner, Senior Editor

■ A Federal Trade Commission (FTC) ruling that Novartis AG be required to sell Miochol-E, an injectable eye care drug used in cataract surgery, has taken effect. Bausch+Lomb has bought the worldwide rights to the drug.

The sale of Miochol-E was part of a settlement that resolves FTC charges that Novartis's proposed acquisition of Alcon, Inc., would be anticompetitive. Novartis and Alcon were the only two US providers of injectable miotics, and the FTC ruled that the acquisition would have created a monopoly in injectable miotics.

Injectable miotics are used to induce miosis. Primarily, surgeons use miotics during cataract surgery to shrink the pupil, which helps them determine whether a rupture has occurred in the eye. The only two miotics products in the market are Miochol-E, which was owned by Novartis, and Miostat, owned by Alcon. US sales of injectable miotics totaled $12.4 million in 2009. Novartis and Alcon had shares of 67% and 33%, respectively.

According to the FTC's ruling, Novartis's acquisition of Alcon would have harmed consumers, who have in the past benefited from the direct competition between Novartis and Alcon. If Novartis were allowed to own both injectable miotics, cataract surgeons would likely have faced higher prices for these drugs, according to the FTC.

To preserve competition, the settlement required Novartis to sell the rights and assets related to Miochol-E to B+L within 10 days of when the Alcon acquisition was consummated. The FTC believes B+L is well-positioned to manufacture and market Miochol-E and compete effectively against Novartis.

Also under the settlement order, Novartis must provide transitional services to ensure that the divestiture to B+L is successful and must transfer its third-party manufacturing arrangements for Miochol-E to B+L as part of the sale. Novartis also must provide technical assistance to help B+L implement procedures to other parts of the manufacturing process.

The FTC vote approving the complaint and proposed settlement order was 4-0-1, with Commissioner William E. Kovacic recused.

In the News … ■ Restasis spokesperson is eye MD. Alison Tendler, MD, the ophthalmologist featured in a widely broadcast TV ad for the dry eye therapy Restasis, has proved so popular that Allergan is now using her in a second commercial that recently began to air nationwide. Dr. Tendler, who specializes in cataract and refractive surgery at Vance Thompson Vision in Sioux Falls, SD, is a board-certified ophthalmologist and member of the American Board of Ophthalmology. Dr. Tendler grew up in South Dakota beginning in Clear Lake, then Sioux Falls. She earned her medical doctorate, graduating with honors, and completed her internship at the University of South Dakota School of Medicine. She continued her training with a three-year ophthalmology residency at the University of Minnesota. Following completion of her residency, Dr. Tendler completed a one-year corneal and anterior segment fellowship with Michael Belin, MD, of the Cornea Consultants of Albany at Albany Medical College, in upstate New York. Dr. Tendler is quoted on the practice Web site as saying she was first approached by a local representative of Allergan. "I didn't know what to make of it," she said. "I was so excited I didn't know who to tell first, so I kept it to myself for a little while. And then I'm like, ‘Okay, this has to come out. I have to let people know.’" ■ Combigan patent challenged by generic. Watson Pharmaceuticals said its subsidiary, Watson Laboratories, filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market brimonidine tartrate and timolol maleate ophthalmic solution 0.2%/0.5% as a generic version of Allergan's Combigan glaucoma medication. Combigan is indicated for the reduction of elevated IOP in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. Allergan responded by filing suit against Watson in the US District Court for the Eastern District of Texas, seeking to prevent Watson from commercializing its product prior to the expiration of its patents. For the 12 months ending July 31, Combigan had total US sales of approximately $98 million, according to IMS Health data. ■ Ista begins phase 3 dry eye program. Ista Pharmaceuticals has initiated a phase 3 clinical program of its proprietary formulation of Remura (bromfenac ophthalmic solution for dry eye) for alleviating the signs and symptoms of dry eye disease. The phase 3 efficacy studies are being conducted under a Special Protocol Assessment agreed upon with the FDA. ■ International launch of Restor toric. During the recent ESCRS meeting, Alcon introduced its AcrySof IQ Restor Multifocal Toric IOL for use outside the United States. This new lens is built on Alcon's AcrySof platform and is designed to provide cataract patients who have astigmatism with a surgical option that delivers increased spectacle independence for near, intermediate and distance visual tasks. Francesco Carones, MD of Milan im planted the first lens. An application for US approval is contemplated for 2012. "This is a significant advancement in IOL technology because it allows surgeons to offer their patients who have pre-existing astigmatism a lens that provides quality vision at all distances after cataract surgery," said Kevin Buehler, Alcon's president and CEO. "The AcrySof IQ Restor Multifocal Toric IOL combines the technologies of Alcon's market-leading AcrySof IQ Restor +3 add multifocal IOL and the AcrySof Toric IOL, and I believe it will expand the advanced technology IOL market." Data cited by Alcon demonstrated that the lens delivers quality of vision similar to the Restor +3.0, including Modulation Transfer Function (MTF) and optical quality at all pupil sizes. ■ NSAID with DuraSite trial. InSite Vision has initiated a 160-patient, phase 1/2 clinical trial of ISV-303, a topical antiinflammatory product intended to reduce the pain and inflammation associated with ocular surgery. ISV-303 combines a low dose of the nonsteroidal anti-inflammatory bromfenac with InSite Vision's proprietary DuraSite technology. "We believe there is a significant opportunity to improve on existing products," said Kamran Hosseini, MD, PhD, vice president of clinical affairs and Chief Medical Officer of InSite Vision. "By leveraging our proven DuraSite technology to extend the duration of drug delivery to the eye, ISV-303 has the potential to offer important advantages in relieving pain and discomfort, as well as improving dosing convenience." Patients will be enrolled in one of four study arms to receive ISV-303 once-daily; ISV-303 twice-daily; vehicle, or an approved topical anti-inflammatory agent twice-daily. Patients will receive drug therapy following an ocular surgery procedure for two weeks, with two weeks of follow-up. Results will be measured by patient response assessment of pain and overall satisfaction, combined with an objective assessment by the treating physician. ■ Phase 3 study for dry eye drug. Israel-based Can-Fite BioPharma said it has initiated an Investigational New Drug application with the FDA for a phase 3 study of its lead drug, CF101, in patients with moderate to severe dry eye syndrome. In an earlier phase 2 study, in which CF101 was taken orally as monotherapy for 12 weeks, a statistically significant benefit in the clearing of fluorescein staining in the nasal, temporal, pupillary and inferior parts of the cornea was documented. CF101 was found to be safe and well tolerated during this study period. In that study, a decrease in IOP was also observed in patients with dry eye. These findings prompted the company to initiate a phase 2 study in patients with glaucoma, which is currently ongoing with CF101. ■ New Lumigan formulation approved. Allergan said the FDA has approved Lumigan (bimatoprost ophthalmic solution) 0.01% as a first-line therapy for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. Lumigan 0.01% is an optimized, lower-concentration reformulation of Lumigan 0.03%. "The approval of Lumigan 0.01% provides doctors with an efficacious, safe and well-tolerated IOP-lowering medication for glaucoma patients who are either starting treatment or are changing their medication regimen," said Scott Whitcup, MD, Allergan's executive vice president of R&D and chief scientific officer. Allergan said that in a three-month study of patients with open-angle glaucoma or ocular hypertension with an average baseline of 23.5 mm Hg, Lumigan 0.01% lowered IOP up to 7 mm Hg from baseline, with only one-third the drug exposure of Lumigan 0.03%. The most common side effects of Lumigan 0.01% are hyperemia, eyelash growth and ocular pruritis. Lumigan 0.01% will be available in the fourth quarter of 2010, Allergan said. ■ B+L names Wechsler. Bausch + Lomb has named Daniel M. Wechsler as corporate vice president and global president of its Pharmaceuticals business. Wechsler was most recently head of US Strategy, Commercial Model Innovation and Business Development for Merck & Co., a role to which he was appointed following the company's acquisition of Schering-Plough in 2009. From 2005 to 2009, he was group vice president, Global Business Operations and Selling Excellence, for Schering-Plough, and a member of the global management team. ■ SARcode names CEO. SARcode Corporation, a biotechnology company focused on developing a novel class of lymphocyte function-associated antigen-1 antagonists for the treatment of dry eye disease, said that Quinton Oswald has joined the company as CEO. Mr. Oswald was most recently at Genentech, where in 2006 he oversaw the commercial launch of Lucentis, the third fastest new product introduction in US pharmaceutical history. SARcode's said its lead product candidate, SAR 1118, has provided excellent phase 2 results in both signs and symptoms of dry eye. The study achieved these results within 12 weeks, demonstrating potential for more rapid relief than currently available therapies, according to SARcode. OM