Pharmacy

Kingston, PA-FDA study results show the safety and effectiveness of the investigational viscous-dispersive ophthalmic viscosurgical device (OVD) DisCoVisc (Alcon Laboratories) for use during cataract surgery and IOL implantation, said Harvey Reiser, MD.

With the relatively recent FDA approval of capsular tension rings (CTRs), cataract surgeons finally have the opportunity to use these devices for their patients

Therapies for the management of age-related macular degeneration (AMD) have progressed rapidly in recent years. Ophthalmology Times convened a panel of cutting-edge retinal specialists from across the United States to discuss the latest in the diagnosis of AMD and to explore current practice patterns with pharmaceutical and surgical treatment options.

The FDA approval in mid-September of the Verisyse/Artisan phakic IOL [Advanced Medical Optics Inc. (AMO) and Ophtec USA] for use in patients with myopia could be the start of a revolution comparable to the advent of LASIK, according to Eric D. Donnenfeld, MD, FACS, one of the investigators who took part in clinical trials of the lens.

San Diego-The Artisan Hyperopia IOL (Ophtec BV) appears to be safe, effective, and stable for the treatment of high and extreme hyperopia, according to Edward E. Manche, MD, who reported the interim results of the FDA phase III clinical trial at the American Society of Cataract and Refractive Surgery annual meeting.

VisiJet Inc. has received FDA approval for its EpiLift System, an ophthalmic surgical device designed for separating corneal tissue.

The U.S. FDA has granted WaveLight Laser Technologie AG, an investigational device exemption that allows the company, based in Erlangen, Germany, to conduct additional clinical studies in the United States for its Allegretto Wave excimer laser system.

Atlanta -Start-up ophthalmic pharmaceutical developer Alimera Sciences Inc. has launched its first product, a multi-dose, emollient-based artificial tear drop.

Fort Lauderdale, FL-Intravenous squalamine lactate being developed by Geneara Corp. shows promise as a safe and effective treatment for choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD), according toresults of a phase I/II trial presented by Charles A. Garcia, MD, at the annual meeting of the Association for Research in Vision and Ophthalmology.

San Diego-The Artisan/Verisyse phakic IOL (Ophtec USA, AMO) fared well in preliminary analysis of data from one U.S. investigational center. It appears to be a safeand effective implant for use in patients with high myopia, according to Kerry Assil, MD, who spoke during the American Society of Cataract and Refractive Surgery annual meeting.

Photodynamic therapy with verteporfin is the most promising of the FDA-approved therapies for exudative CNV.

San Diego-Regression after refractive surgery may be reduced by using ultraviolet A (UVA) cross-linking techniques to stabilize the cornea. The preliminary results of UVA cross-linking after refractive procedures demonstrated that regression stopped in the near term and appeared to be without adverse effects.

Pre-formed gel masks are applied to patients requesting injectable cosmetic therapies.

Dallas-Refocus Group Inc., a medical device company engaged in the research and development of treatments for eye disorders, announced promising preliminary data from the company's ongoing phase II clinical trials for the treatment of presbyopia.

Understanding of chronic dry eye has come a long way in recent years. The treatment spectrum has expanded and ophthalmologists now have a range of therapeutic options.

Rockville Center, NY-Nedocromil sodium is the mainstay of therapy for patients who need chronic medication because it offers continued relief without the development of tolerance.

Baltimore-A dexamethasone posterior segment drug delivery system (Posurdex, Allergan), developed by Oculex Pharmaceu- ticals, performed well in a phase II trial in patients with macular edema, with a 700-?g dose achieving statistically significant results when compared with an observation-only control group, according to Julia A. Haller, MD.

Fort Lauderdale, FL-The investigational drug tin ethyl etiopurpurin (SnET2) produced a visual acuity benefit and slowed the development of neovascular lesions in two phase III trials of SnET2 photodynamic therapy (PDT) (Miravant Medical Technologies) for the treatment of subfoveal choroidal neovascularization associated with wet age-related macular degeneration, said Edgar L. Thomas, MD, Retina-Vitreous Associates, Los Angeles.

Fort Lauderdale, FL-The investigational drug tin ethyl etiopurpurin (SnET2) produced a visual acuity benefit and slowed the development of neovascular lesions in two phase III trials of SnET2 photodynamic therapy (PDT) (Miravant Medical Technologies) for the treatment of subfoveal choroidal neovascularization associated with wet age-related macular degeneration, said Edgar L. Thomas, MD, Retina-Vitreous Associates, Los Angeles.

Fort Worth, TX-Alcon Inc. has filed the second of three parts of its "rolling" new drug application for anecortave acetate for depot suspension (Retaane) 15 mg, an investigational treatment for patients with wet age-related macular degeneration (AMD).

Alpharetta, GA-A new company forged by four former executives with Novartis and its related groups has pocketed nearly $27 million in venture capital and plans to launch a line of novel eye-care products.

Euclid Systems Corp. has won FDA approval for the overnight wear of its Emerald orthokeratology (Ortho-k) lens.

The FDA has approved a new drug application by ISTA Pharmaceuticals for the once-daily liquid formulation of timolol 0.5% as a therapy for glaucoma.

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.