Pharmacy

Recent advances in biotechnology and tissue engineering are providing promise that in the future, tissue replacements or renewal techniques might be used to restore lost vision in eyes with genetic, malignant, or degenerative diseases.

Irvine, CA—Allergan Inc. has signed an exclusive licensing agreement with Japan's Sanwa Kagaku Kenkyusho Co. Ltd. to develop and commercialize Posurdex for the ophthalmic marketplace in that country.

The AcrySof ReSTOR apodized diffractive IOL (Alcon Laboratories Inc.) recently received FDA approval for cataract patients with and without presbyopia. In clinical trials, 80% of patients reported never wearing reading glasses or bifocals following cataract surgery and implantation of the new lens.

ISTA Pharmaceuticals has filed an investigational new drug application with the FDA to initiate a phase III study of a new combination ophthalmic product containing tobramycin and prednisolone acetate for the treatment of steroid-responsive inflammatory ocular conditions where risk of bacterial infection exists.

Novagali Pharma, a biopharmaceutical company based in Evry, France, which develops innovative drug delivery systems in ophthalmology, has appointed seven individuals to its scientific advisory board. The company chose experts from America, Japan, Israel, and France.

The ingenuity of pharmaceutical researchers continues to amaze in their bility to devise inventive solutions and improve upon our current arsenal of ophthalmic medications, devices,and delivery systems.

Multiple sclerosis (MS) can present to the ophthalmologist with visual loss (e.g., opticneuritis), diplopia (e.g., internuclear ophthalmoplegia [INO] or sixth-nerve palsy), or nystagmus.

An implantable miniature telescope (IMT, VisionCare Ophthalmic Tech- nologies, Saratoga, CA) may offer improved visual acuity and quality of life in patients with bilateral, endstage age-related macular degeneration (AMD), according to Paul R. Lichter, MD, who made a presentation on behalf of the investigators.

Lexington, SC—International publisher and alternative medicine expert Burton Goldberg, PhD, has joined Biosyntrx's Scientific Advisory Board.

Pittsburgh—Senior executives from some 50 biotechnology, pharmaceutical, and device firms examined the potential for combination drug/device therapies in a weekend conference showcasing the most promising advances.

Irvine, CA—Allergan Inc. has signed an exclusive licensing agreement with Japan's Sanwa Kagaku Kenkyusho Co. Ltd. to develop and commercialize Posurdex for the ophthalmic marketplace in that country.

Irvine, CA—ISTA Pharmaceuticals is asking the FDA for permission to conduct a phase IIb clinical trial for ecabet sodium, a prescription eye drop for treating keratoconjunctivitis sicca (dry eye syndrome).

Albuquerque, NM—The FDA approved a wavefront-guided LASIK procedure (CustomVue, VISX/AMO) for treating mixed astigmatism on March 22.

The FDA approval for marketing of bromfenac ophthalmic solution 0.09% (Xibrom, ISTA Pharmaceuticals) gives the topical medication the distinction of being the first nonsteroidal anti-inflammatory drug (NSAID) in the United States indicated for twice-daily instillation in the management of ocular inflammation after cataract surgery.

Washington, DC &#8212 Alcon Laboratories Inc. introduced the newest addition to its IOL family during a press conference Monday. The AcrySof ReSTOR apodized diffractive IOL recently received FDA approval for cataract surgery in patients with or without presbyopia.

Washington, DC &#8212 With the recent acquisition of VISX and last month's FDA approval of its ReZoom multifocal refractive lens, Advanced Medical Optics (AMO) appears to be experiencing "some exciting times" in ophthalmology.

New York—Laser presbyopia reversal (LAPR) is showing significant promise and patient satisfaction based on 12-month follow-up results from a U.S. phase II clinical trial, said Sandra C. Belmont, MD.

Seattle, WA—Visient Therapeutics Inc. has enrolled its first patient in a new phase I clinical trial to evaluate Light Infusion Technology (Litx) in patients with advanced age-related macular degeneration (AMD). The patient was treated by Gary Edd Fish, MD, at Texas Retina Associates in Dallas.

Toronto—The FDA is allowing OccuLogix Inc. to initiate studies of its RHEO blood filtration system to treat dry age-related macular degeneration after reviewing the Long-term Efficacy in AMD from Rheopheresis in North America (LEARN) protocols.

Plymouth Meeting, PA—Six patients treated with 40 mg of Genaera Corp.'s squalamine lactate (Evizon) had preserved or improved vision in both eyes suffering from wet age-related macular degeneration through a 4-month study, according to the company, which released preliminary results of a phase II clinical trial.

Santa Barbara, CA—Miravant Medical Technologies will conduct phase III clinical trials for rostaporfin (PHOTREX) at 50 investigational sites in central and eastern Europe and the United Kingdom to evaluate a range of patients with wet age-related macular degeneration.

With the push of a button, refractive surgeons now have the capability to align wavefront-guided customized ablations to the correct corneal site. Iris Registration (IR) technology from VISX for use with CustomVue treatment is the first and only FDA-approved, fully automated, non-contact method available to CustomVue surgeons in the United States. The technology is being regarded for its potential to enhance the further efficacy and safety of custom ablations with the VISX system.

Memphis—Switches within rather than between classes of glaucoma medications are less common but appropriate when likely to produce an improvement in efficacy, adverse effects, or compliance, said Peter Andreas Netland, MD, PhD, Siegal Professor of Ophthalmology, University of Tennessee Health Science Center, Memphis.

Indianapolis—The investigational compound ruboxistaurin (Eli Lilly and Co.) may reduce the risk of vision loss associated with diabetic macular edema (DME), according to post hoc analysis of previously reported data. The new analysis also showed that the proximity of DME to the center of the macula was associated with visual acuity and that the severity of central macular involvement was associated with the severity of vision loss, according to Matthew J. Sheetz, MD, PhD, a clinical research physician at Eli Lilly.

Antibiotic resistance is a growing challenge, especially in ophthalmic surgery, and clinicians must remain vigilant and well informed to reduce the risk of infection in their patients, said Michael B. Raizman, MD, a cornea specialist with Ophthalmic Consultants of Boston.