Pharmacy

The FDA sent an approval letter to Eli Lilly and Co. for ruboxistaurin mesylate (Arxxant), an investigational oral therapy for the treatment of diabetic retinopathy.

The FDA approved WaveLight’s wavefront-guided procedure, a LASIK treatment approach that combines the Allegro Analyzer with the 200-Hz Allegretto Wave excimer laser.

Aliso Viejo, CA-Since FDA approval in 2003, more than 50,000 crystalens accommodating IOLs (eyeonics) have been implanted worldwide. Of these, 17,000 implants were with the crystalens SE second-generation lens (introduced in 2005), the company said in a prepared statement.

Irvine, CA-Visiogen Inc.'s dual-optic accommodating IOL (Synchrony) has received CE Mark designation.

Irvine, CA-ISTA Pharmaceuticals Inc. announced it has filed a New Drug Application (NDA) with the FDA for its investigational ophthalmic product (T-Pred) containing tobramycin and prednisolone acetate in a fixed combination. The company hopes the drug receives approval as a treatment for inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists.

Charleston, SC-The brimonidine 0.2%/ timolol 0.5% fixed combination (Combigan, Allergan) administered twice daily is as effective as the concurrent use of brimonidine and timolol and is significantly more effective than monotherapy with either brimonidine three times daily or timolol twice daily, according to E. Randy Craven, MD, who presented his results at the American Glaucoma Society meeting here. The fixed combination is also superior to brimonidine monotherapy in long-term safety and the development of fewer ocular allergies, Dr. Craven said.

Azelastine is formulated to have a very long half life and a very high affinity for the H1 receptor it affects.

San Francisco-Discontinuing the use of cyclosporine ophthalmic emulsion 0.05% (Restasis, Allergan), the only FDA-approved drug to treat dry eye, may result in recurrence of the signs and symptoms of keratoconjunctivitis sicca (KCS), and reinstitution of the drug is needed to reverse those signs and symptoms, John Sheppard, MD, reported at the annual meeting of the American Society of Cataract and Refractive Surgery.

Commonly used systemic antihistamines taken for seasonal allergies can cause ocular surface drying that in turn aggravates ocular allergy symptoms. Antihistamine drops specifically formulated for ocular allergies, in contrast, do not appear to decrease tear volume or tear flow or cause ocular surface damage, according to several investigators who have studied ocular drying. However, in a separate mouse study, topical ocular allergy medications themselves may have different effects on tear volume or tear flow.

Tampa, FL-Sirion Therapeutics Inc. agreed to receive exclusive U.S. licensing rights to a topical ophthalmic emulsion containing difluprednate, a steroid compound that may treat inflammatory eye diseases.

Oakbrook Terrace, IL-The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) issued 2007 National Patient Safety Goals for ambulatory care facilities and offices in which surgery is performed.

Irvine, CA-Senju Pharmaceuticals will transfer exclusive North American rights of two investigational drugs-iganidipine, a calcium-channel blocker, and a new formulation of latanoprost, a prostaglandin analogue-to ISTA Pharmaceuticals. Both investigational formulations may treat glaucoma or other ophthalmic applications.

Eli Lilly and Co. and Alcon Laboratories have reached an agreement to co-promote ruboxistaurin mesylate (proposed brand name, Arxxant) in the United States and Puerto Rico. The agreement is contingent upon FDA approval. The government agency is currently reviewing the oral drug as a treatment for moderate-to-severe nonproliferative diabetic retinopathy.

ISTA Pharmaceuticals filed a New Drug Application for its investigational tobramycin and prednisolone acetate in a fixed combination (T-Pred). The company hopes the drug receives approval as a treatment for inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists.

Philadelphia-Acuity Pharmaceuticals and ZaBeCor Pharmaceutical Co. entered into a license option agreement in which Acuity gains exclusive development and commercialization rights to ophthalmic applications of a small interfering RNA (siRNA).

Retinal specialists have a new therapy in their armamentarium for treating patients with neovascular age-related macular degeneration (AMD).

Identifying and prescribing the optimum non-steroidal anti-inflammatory drug (NSAID) to help patients get the best possible LASEK result is a crucial part of the surgical treatment plan. Likewise, postoperative non-compliance can weaken the outcome of an otherwise perfect procedure.

Fort Lauderdale, FL-An investigational longacting solution of 1.0% azithromycin (AzaSite, InSite Vision) is safe, well tolerated, and effective for the treatment of bacterial conjunctivitis in pediatric patients and adults, according to the results of pivotal phase III clinical trial involving placebo and active controls.

ISTA Pharmaceuticals gained exclusive North American rights to Senju Pharmaceuticals' iganidipine, a calcium-channel blocker, and a new formulation of latanoprost, a prostaglandin analogue.

ISTA Pharmaceuticals gained exclusive North American rights to Senju Pharmaceuticals' iganidipine, a calcium-channel blocker, and a new formulation of latanoprost, a prostaglandin analogue.

Compared with placebo, ruboxistaurin mesylate ( proposed brand name , Arxxant, Eli Lilly and Co.) reduces the risk of sustained moderate vision loss by 41% in patients with moderate-to-severe nonproliferative diabetic retinopathy, according to pooled data from two 3-year phase III trials. Eli Lilly and Co. presented the findings at the American Diabetes Association's annual scientific sessions recently.

(OSI) Eyetech Pharmaceuticals Inc. and Pfizer Inc. have initiated a phase IV trial that will study whether use of pegaptanib sodium injection (Macugen) following neovascular age-related macular degeneration (AMD) therapy provides a balance in long-term safety and efficacy. Called LEVEL (EvaLuation of Efficacy and safety in maintaining Visual acuity with sEquential treatment of neovascuLar AMD), the 54-week trial will comprise up to 1,000 patients at 100 sites across the country.

The femtosecond pulses offer real, precise subsurface effects, with the least amount of energy required.

The femtosecond pulses offer real, precise subsurface effects, with the least amount of energy required.

The use of hormonal therapies may represent the next generation of medication for the tear film deficiencies of dry eye.