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Industry News in Brief
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Alimera Sciences initiates phase 3 trial for implant treatment of DME
ATLANTA — Alimera Sciences Inc., in collaboration with Control Delivery Systems Inc., has announced the initiation of a phase 3 clinical trial to study the Medidur implant’s effect on patients with diabetic macular edema. The implant uses fluocinolone acetonide, Alimera’s pharmological treatment for DME.
The study will involve 900 patients in Europe and the United States and will monitor their condition over a 36-month time span. The implant, which can be inserted in the eye with a needle in an in-office procedure, is designed to supply a sustained dose of fluocinolone acetonide to the back of the eye over a 3-year period.
Alimera and CDS announced their collaboration and their plans to jointly develop and market Medidur in February 2006.
B&L completes acquisition of Chinese firm
ROCHESTER, N.Y. – Bausch & Lomb has completed its acquisition of Chinese pharmaceutical company Shandong Chia Tai Freda, B&L announced in a press release.
The Chinese company primarily develops, manufactures and markets medications used to treat ocular inflammation and infections, glaucoma and dry eye, the release said. In 2004, the company posted sales of $62 million.
B&L agreed to purchase the company for $200 million in cash from its current owner, Sino Biopharmaceutical. The acquisition will be “essentially neutral” to 2005 earnings per share for B&L, the release said.
CooperVision to distribute Gebauer epi-LASIK products
LAKE FOREST, Calif. – CooperVision Surgical signed an agreement to be the exclusive distributor for Gebauer Medizintechnik’s epi-LASIK products, the company announced in a press release. Terms of the agreement were not disclosed.
The EpiVision system brings “accuracy and control” to surgeons performing epi-LASIK, according to the release. The system “precisely and safely separates the epithelium from the next layer of corneal tissue, Bowman’s membrane,” the release stated. Eliminating the cutting of the stromal flap helps eliminate the most common cause of LASIK complications, the release said.
CooperVision Surgical currently distributes the AlphaCor, an artificial cornea, and the AlphaSphere, a soft orbital implant. CooperVision Surgical is a division of CooperVision, a manufacturer and marketer of contact lenses and ophthalmic surgical products.
Artiflex phakic IOL receives CE Mark
GRONINGEN, Netherlands – A foldable phakic IOL for the treatment of myopia has been granted the CE Mark in Europe, lens maker Ophtec said in a press release.
The Artiflex is a foldable version of the company’s Artisan phakic IOL (marketed by Advanced Medical Optics as the Verisyse in the United States and other markets).
“The significant benefit of the Artiflex is that it can be inserted through a minimally invasive microincision, therefore dramatically reducing recovery time and increasing patient satisfaction,” according to Ophtec.
Erik Jan Worst, MD, president and chief executive officer of Ophtec, said surgeons involved in the clinical trial of the Artiflex “were amazed by the results and quick visual recovery.”
The new lens will be available immediately in Europe to surgeons who have completed a specialized training course, the press release said.
Iridex introduces otologic/ophthalmic laser
MOUTAIN VIEW, Calif. – A green laser that can be used by both otologists and ophthalmologists is now available from Iridex, the company announced.
The Iridex OcuLight OR is a solid-state, 532-nm laser system designed for use in a hospital setting to treat otosclerosis or to perform retinal photocoagulation, the company said in a press release. The laser “was specifically designed for the operating room environment and contains a user-friendly control interface,” the release said. It is compatible with laser indirect ophthalmoscopes and endophotocoagulation probes as delivery device options for ophthalmologists to perform retinal photocoagulation procedures, the release noted.
Allergan, Sirna to develop AMD drug
SAN FRANCISCO – A novel RNA interface-based drug currently in phase 1 development for the treatment of age-related macular degeneration will be jointly developed by Allergan and Sirna Therapeutics, the companies announced in a press release.
Sirna-027 will now be developed and commercialized by Allergan, Sirna said in the release. Sirna will receive an initial $5 million payment. The two companies also agreed to develop other novel RNAi-based therapeutics against select gene targets in ophthalmic diseases. Sirna will be eligible for up to $245 million from Allergan, based on worldwide sales derived from the alliance.
According to the development agreement, Allergan will be responsible for all preclinical, clinical and commercialization activities related to RNAi compounds initially developed by Sirna.
RNA interference is a natural, selective process for turning off genes, according to Sirna. It is triggered by short interfering molecules that engage a group of cellular proteins. Results to date on Sirna-027 indicate the compound is safe and well-tolerated, the company added. Visual acuity stabilized in all patients treated, and a clinically significant improvement of three lines or more on the ETDRS eye chart was observed in 25% of the patients tested, according to Sirna.
FDA: Travatan ads ‘misleading’
WASHINGTON – A popular glaucoma drug’s promotional material has been deemed misleading by the Food and Drug Administration, according to a letter sent to the drug’s marketer.
Alcon’s Travatan (travoprost) is indicated for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension who are intolerant of other IOP-lowering medications. The FDA’s Division of Drug Marketing, Advertising and Communications has determined a flash card Alcon uses in its marketing is “false or misleading because it fails to reveal material facts, presents unsubstantiated superiority claims, broadens the indication, minimizes risks and presents dosing claims that are unsubstantiated and inconsistent with the approved product labeling.”
The group told Alcon the flash card misbrands the drug by suggesting Travatan is safer or more effective than has been demonstrated and encourages use in circumstances other than those in which Travatan has been shown to be safe and effective.
Alcon had until Oct. 6 to respond to the letter.
Earlier this year, the FDA cited Allergan for misleading promotional material for its glaucoma medication Lumigan (bimatoprost). Allergan had until Sept. 20 to issue a written response to the false advertising claims.
IMI initiates clinical trial for retinal implant
ZUG, Switzerland — Intelligent Medical Implants announced that it will begin a clinical study of the newly developed first-generation Learning Retinal Implant System, which contains a 50-electrode device.
The study will commence at the University of Hamburg Medical School in the fourth quarter of this year. Until now, only a 16-electrode array has been tested on humans. IMI also hopes to report the preliminary results of this trial during this time period as well.
CooperVision to distribute Gebauer’s products worldwide
LAKE FOREST, Calif. — CooperVision Surgical announced that it has entered into an agreement with Gebauer Medizintechnik GmbH for the rights to worldwide distribution of Gebauer’s Epi-LASIK products.
CooperVision Surgical, a division of CooperVision Inc., was formed in February 2004. Gebauer is a German engineering and medical device firm.
Transitions Optical announces more television advertising
PINELLAS PARK, Fla. — Transitions Optical announced that it will be releasing a large round of television advertising in the final months of 2005. The advertisements will be run during high-profile primetime programs, including the Macy’s Thanksgiving Day Parade on NBC, the 30th Annual Country Music Awards on CBS, and Barbara Walters “10 Most Fascinating People” on ABC.
The advertisements will also be run on other popular cable channels, including The Weather Channel, TV Guide, TNT and the History Channel, throughout October and November.