Pharmacy

Anti-VEGF monoclonal antibody fragment improves vision, reduce fluorescein angiographic leakage

Miami-Treatment with small interfering RNA (siRNA) directed against vascular endothelial growth factor (VEGF) is showing promise as a new therapy for choroidal neovascularization (CNV), according to Michael J. Tolentino, MD, who spoke at Angiogenesis 2004.

Irvine, CA-ISTA Pharmaceuticals Inc. is seeking FDA approval of its bromfenac sodium ophthalmic solution 0.1% (Xibrom) for the treatment of ocular inflammation following cataract surgery.

Genaera Corp. will begin three phase II trials on squalamine, its systemically administered anti-angiogenic drug.

The FDA has approved Nidek Inc.'s advanced 200 Hz Eye Tracker for use with its EC-5000 excimer laser system.

Fort Worth, TX-Alcon Inc. is adding 22 susceptible pathogens to its moxifloxacin HCl 0.5% ophthalmic solution (Vigamox) in vitro labeling. The additions, which the FDA approved in late April, include atypical mycobacteria and Propionibacterium acnes. Alcon said its fourth-generation fluoroquinolone eye drop now offers the broadest spectrum in the ophthalmic fluoroquinolone category.

Washington, DC-Four manufacturers of ocular products have received FDA approval to market ofloxacin ophthalmic solution 0.3%, a generic version of Allergan Inc.'s Ocuflox, for the treatment of certain strains of bacteria in conjunctivitis and corneal ulcers.

Fort Worth, TX-A nasal formulation of olopatadine HCl ophthalmic solution 0.1% (Patanol, Alcon) reduced seasonal allergic rhinitis symptoms compared with placebo, according to phase III study results.

Branded drug with lower concentration does offer a better side effect profile than generics

Positive effect seen with azelastine solution in early, late phases of allergic response

Study showed effective relief of ocular signs, symptoms of allergic conjunctivitis

Carl Zeiss Meditec announced that the company has submitted an InvestigationalDevice Exemption (IDE) application to the FDA for LASIK utilizing the MEL-80Excimer Laser System.

Epi-K, an epithelial separator being developed by Moria, has been usedin a small Mexican study of 22 patients for the creation of epithelialflaps for the Epi-LASIK procedure, reported Barrie Soloway, MD, at the AmericanSociety of Cataract and Refractive Surgery (ASCRS) annual meeting.

Miravant Medical Technologies is asking the FDA to okay a new drug application for marketing approval of its SnET2-PDT as a treatment for patients with wet form of age-related macular degeneration (AMD).

Irvine, CA-The FDA approval of the ViewPoint CK System (Refractec Inc.) for the NearVision conductive keratoplasty (CK) procedure marked a milestone as the first technology to improve near vision in presbyopic patients (See related story from Ophthalmology Times, March 1 issue). The laser-free procedure-which uses radiowaves to reshape the cornea-can be performed in less than 3 minutes with topical anesthesia in the ophthalmologist's office.

Santa Ana, CA-Patients who either are severely myopic or fear laser surgery are one step closer to an alternative refractive treatment with the anticipated FDA approval of the Artisan/Verisyse phakic IOL (AMO).

ASCRS Exhibit Hall Highlights

Santen, Napa, CA, has named Mark Mannebach, PhD,RPh, as its new vice president of regulatory affairs and Mike Ford as itsdirector of professional relations.

Fort Lauderdale-The FDA has approved a supplemental list of susceptiblepathogens to the in vitro labeling of Vigamox ophthalmic solution, AlconLaboratories announced Monday.

Results of a controlled Phase I/II study show that the bioerodable, sustained-release,dexamethasone implant (Posurdex, Allergan) results in a statistically significantincrease in ETDRS standardized visual acuity in eyes with persistent cystoidmacular edema (CME), said Mark S. Blumenkranz, MD.

Two Phase III studies are now underway evaluating ranibizumab (formerlyrhu Fab V2, Lucentis; Genentech) for the treatment of exudative age-relatedmacular degeneration (AMD). The studies are based on Phase I/II study results,demonstrating it is well tolerated and offers promising biological and clinicalactivity, said Jeffrey S. Heier, MD.

One-year data from the pivotal Phase II/III VEGF Inhibition Study inOcular Neovascularization (VISION) indicate that selective anti-VEGF165(Macugen, Eyetech/Pfizer) treatment improves visual outcomes and offersa highly favorable systemic and ocular safety profile, said Steven Schwartz,MD.

Calling for an interdisciplinary approach to clinical research, StephenE. Strauss, MD, director of the National Center for Complementary and AlternativeMedicine at the National Institute of Health (NIH), outlined a comprehensiveplan for how research will some day be conducted in the United States. Theplan would incorporate the many fields of medicine with the many disciplinesin research to form a "common core of knowledge."

Genentech, South San Francisco, CA, announced that the biotechnologycompany is enrolling patients into a Phase III clinical trial for its age-relatedmacular degeneration (AMD) drug Lucentis (ranibizumab, rhuFab V2).

Madrid-Researchers specializing in technologies for the blind have until May 31 to submit entries in the third ONCE International Research & Development Competition in Biomedicine and New Technologies for the Blind.