Ophthalmology Times Staff Reports

Iridex Corp. has launched www.treatmydme.com, an educational Web site designed to benefit patients who have diabetic macular edema (DME).

Portugal’s National Authority of Medicines and Health Products has granted marketing authorization to Alimera Science’s proprietary preparation of 190 µg fluocinolone acetonide intravitreal implant in applicator (Iluvien) for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies, according to the company.

Bausch + Lomb (B + L) has completed its acquisition of ISTA Pharmaceuticals Inc.

ThromboGenics NV has been notified by the FDA that its new biologic license application (BLA) for ocriplasmin intravitreal injection will be discussed by the Dermatologic and Ophthalmic Drugs Advisory Committee on July 26.

Prevent Blindness America has declared June as Cataract Awareness Month and is providing free information to the public about cataracts and cataract surgery.

Peng T. Khaw, MD, PhD, FARVO, is the new president of the Association for Research in Vision and Ophthalmology (ARVO). He succeeds Jeffrey Boatright, PhD, FARVO, whose 1-year term ended in May.

Glaukos Corp. has been selected as a Red Herring Top 100 North America Tech Startup, an award honoring the year’s most promising private technology ventures. Glaukos is the only medical device company in North America to be selected for this honor.

Bausch + Lomb (B + L) has launched a new daily disposable contact lens (Biotrue ONEday). According to the company, the lens is made from a proprietary material (HyperGel) that combines features of conventional hydrogel and silicone hydrogel material.

A 109-year-old Chinese patient with cataracts has received two IOLs in surgeries that are pending a Guinness World Records decision in the World’s Oldest Cataract Surgery Patient category.

The therapeutics pipeline for retinal vein occlusion (RVO) is weak and likely to remain so for several years, according to a report by GlobalData.

In addition to angiogenesis, vascular endothelial growth factor (VEGF) may have another function, according to scientists at the Schepens Eye Research Institute. The finding could lead to the prevention of the most common serious side effect of retinal re-attachment surgery.

The Burke Medical Research Institute has been awarded a 5-year, $2,262,500 scientific research grant by the National Eye Institute of the National Institutes of Health.

The hazards to the eyes of ultraviolet (UV) radiation are well known to eye-care professionals, but it’s possible they’re not conveying the need for UV protection strongly enough to their patients.

Avalanche Biotechnologies Inc. and Lonza have announced a manufacturing collaboration focused on process development and scale-up efforts for the manufacturing of adeno-associated viral (AAV) vectors for gene therapy.

Smartphones can be a big help to the visually impaired, but few eye-care professionals (ECPs) are recommending them to patients, according to the results of a study presented at this year’s annual meeting of the Association for Research in Vision and Ophthalmology.

Bioptigen has received 510(k) clearance from the FDA to begin marketing its hand-held spectral-domain optical coherence tomography (OCT) device (Envisu) for use in patients.

Nidek has received FDA 510(k) clearance for a non-mydriatic automated fundus camera (AFC-330) that it will market to the U.S. ophthalmology market and Marco Ophthalmic will market to the optometry market.

Abbott Medical Optics (AMO) has announced an impending change in leadership with the expected retirement of James V. Mazzo, president and chief executive officer (CEO), by the end of this year. Mazzo will be succeeded by Murthy Simhambhatla, PhD, who currently heads the Ibis Biosciences division of AMO’s parent company, Abbott Laboratories.

The search is on for beautiful eyes. From now until Aug. 31, online voting will be held for the Prevent Blindness America Most Beautiful Eyes Contest at www.facebook.com/preventblindness, or mobile device users may go to www.preventblindness.org/mbe-mobile.

The United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for 190 µm fluocinolone acetonide intravitreal implant in applicator (Iluvien, Alimera Sciences) for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

The Pediatric Cataract Initiative (PCI) has awarded two research grants of $50,000 each, for projects by ORBIS in South Africa and Zambia and The International Centre for Eye Health (ICEH) in Bangladesh, for their work to reduce the prevalence of childhood blindness.

Bayer HealthCare’s Japanese subsidiary, Bayer Yakuhin Ltd., and Santen Pharmaceutical Co. Ltd. have entered into a co-promotion agreement for aflibercept injection (Eylea, also known as VEGF Trap-Eye; Regeneron Pharmaceuticals) in Japan.

ISTA Pharmaceuticals representatives say they intend to file a new drug application (NDA) with the FDA for the company’s bromfenac ophthalmic solution (Prolensa) before the end of June, based on the results of two phase III studies.

The importance of dilated eye exams is the focus of EyeSmart Week this week, being celebrated by the American Academy of Ophthalmology (AAO). To learn more about its observance, visit www.geteyesmart.org.

Ocular Therapeutix has begun a feasibility study of a punctal plug delivering sustained-release travoprost (Travatan and Travatan Z, Alcon; Travo-Z, MicroLabs) to treat glaucoma.

The FDA has accepted the filing of Lux Biosciences? new drug application for oral voclosporin (Luveniq) and has granted the application priority review, according to the company.

Acucela Inc. and Otsuka Pharmaceutical Co. Ltd. have received fast-track designation from the FDA for ACU-4429, an investigational oral treatment for dry age-related macular degeneration.

The FDA has accepted for review the supplemental new drug application (sNDA) of ISTA Pharmaceuticals Inc. for once-daily bromfenac ophthalmic solution (XiDay).

Alcon Laboratories Inc. has received regulatory approval and finalized the acquisition of the rights in the United States for difluprednate ophthalmic emulsion 0.05% emulsion (Durezol) and the global rights, excluding Latin America, for cyclosporine (Zyclorin) from Sirion Therapeutics Inc. Alcon immediately assumed responsibility for all marketing, promotion, and sales of the difluprednate formulation.

Haag-Streit USA has appointed Alcon Laboratories Inc. as its exclusive distributor in the United States for an optical biometer (Lenstar LS900).