Pharmacy

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.

Mannheim, Germany-The AcrySof phakic anterior chamber angle supported lens (Alcon) for the correction of high myopia provides patients with excellent uncorrected visual acuity (UCVA). Importantly, no progressive endothelial cell loss, angle deformation, or irritation developed, according to Michael C. Knorz, MD, who reported results from a phase I study of the lens.

Among the 233 sessions dedicated to retina, almost 75 are free papersand symposia sessions. The Editorial Advisory Board of OphthalmologyTimes reviewed the retina abstracts to be presented at this year's meeting.Some of the board's selections are highlighted here.

The program for Sunday, April 25, features a number of scientific offerings,but one highlight is the annual keynote address. It will be given duringa session scheduled from 5 to 7 p.m. in Ballroom A-D. This year's keynotespeaker is Stephen E. Straus, MD, director, National Center for Complementaryand Alternative Medicine, National Institutes for Health (NIH), Bethesda,MD. His address, entitled "Envisioning New Models for ClinicalResearch", will describe the NIH-developed "Roadmap"-astrategy for accelerating basic science discoveries and for translatingthat research into clinical practice.

Miami-Treating glaucoma in pregnant patients requires additional considerations. Patients with glaucoma should be advised that, although the risk to the fetus and patient is low, treatment is not without risk.

Minneapolis, MN-The new fluoroquinolone, levofloxacin 1.5% ophthalmic solution (IQUIX, Santen), has received FDA approval to be marketed for the treatment of bacterial corneal ulcer. The approval brings with it a milestone as the first current-generation fluoroquinolone with an indication for use in the management of that sight-threatening condition, explained Richard L. Lindstrom, MD.

Sarasota, FL-Data from three clinical trials show that Travatan/Timolol Fixed Combination (TTFC), Alcon's investigational new drug to treat glaucoma, is a safe alternative to the two single compounds dosed concomitantly, the company says.

Irvine, CA-The FDA is extending its review of ISTA Pharmaceuticals Inc.'s new drug application for Vitrase for use as a spreading agent by 90 days to allow for a full review.

Philadelphia-Acuity Pharmaceuticals has raised $2.4 million in its first institutional round of financing to fund pre-clinical studies of Cand5, being developed for treating age-related macular degeneration (AMD).

Anaheim, CA-Performing cataract surgery in an eye with a failing filtering bleb is a tricky business, which has been addressed by a few different procedures. Successful intervention can be achieved in carefully selected patients. However, in those in which intervention might be problematic, a new investigational device is under study to lower IOP, according to Reay H. Brown, MD.

New information regarding the adverse effects of tear film hyperosmolarity on the ocular surface lends further support to the efficacy of a hypotonic artificial tear product (TheraTears, Advanced Vision Research) in the management of dry eye.

As dependence on computers continues to grow, an increasing number of people seek medical attention for eye-strain, blurred vision, ocular dryness, and ocular fatigue.

Anaheim, CA-Cyclosporine 0.05% ophthalmic emulsion (Restasis, Allergan) provides similar, significant improvement in the signs and symptoms of dry eye in both patients with keratoconjunctivitis sicca (KCS) associated with autoimmune disease and in those with non-Sj?gren's KCS, said Scott M. Whitcup, MD, at the annual meeting of the American Academy of Ophthalmology.