Month: June 2014

BLOG: Is the FDA finally moving forward on novel IOLs?

For many years now, a forlorn expression has crossed the faces of American doctors when a non-United States speaker approaches the podium to describe IOL designs available only in their countries.Presbyopia-correcting IOL (PC-IOL) technologies available here are beyond 10 years old and, except for Crystalens (Bausch + Lomb), we still don’t have toric PC-IOLs. And what of promising implants like the dual-optic Synchrony IOL?

Iluvien receives marketing authorization in Italy for chronic DME treatment

Alimera Sciences announced it has received marketing authorization from the Italian Medicines Agency for Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema, according to a company press release.“Iluvien has now been granted marketing authorizations in all seven EU countries in which we initially applied,” Dan Myers, Alimera’s president and CEO, said in the press release. “Additionally, we are engaged in a Repeat Use Procedure through Mutual Recognition to obtain a positive opinion for approval from another 10 EU countries.”

Ohr announces positive interim clinical results from Phase 2 wet AMD treatment study

Ohr Pharmaceuticals has announced that its phase 2 study of Squalamine eye drops for the treatment of wet age-related macular degeneration has produced positive top-line interim results, according to a company press release.“The data further validate not only the clinical utility of noninvasive topical eye drop therapies for macular and retinal disorders, but also the soundness of our company’s drug development science and our proprietary formulation technologies that enable topical dosing to achieve positive therapeutic effects in back-of-the-eye disorders,” Irach B. Taraporewala, Ohr president and CEO, said in the release. 

Microaneurysms shed light on diabetic retinopathy

SAN FRANCISCO — The identification of microaneurysm wall features have been correlated with anatomic and functional outcomes in the eyes of diabetes patients, according to data presented at the American Diabetes Association’s 74th Scientific Sessions.“We have classically graded hallmark vascular lesions, allowing staging of diabetic retinopathy severity and risk for diabetic retinopathy progression, but we are generally unable to assess new microaneurysm vessels and other pathology at the cellular level in vivo in human eyes,” Jennifer K. Sun, MD, said during a presentation here.

Tecnis Symfony IOL granted CE mark in Europe

Abbott has received CE mark in Europe for its Tecnis Symfony Extended Range of Vision IOL, indicated for cataract patients with presbyopia, according to a company press release.“With the available advances in IOL technology, many patients are not satisfied with having to wear reading glasses after cataract surgery, which is often the result when using conventional monofocal IOLs,” Gerd U. Auffarth, MD, professor and chairman of the department of ophthalmology at Ruprecht-Karls University of Heidelberg, Germany, said in the press release. “The Tecnis Symfony Extended Range of Vision IOL enables (Read more...)

RETeval device a viable option for diabetic retinopathy screening

SAN FRANCISCO — The RETeval device may be a promising new screening tool for diabetic retinopathy due to its ease of use and low failure rates, according to late-breaking data presented at the American Diabetes Association’s 74th Scientific Sessions.“These data are clinically relevant for ophthalmologists and endocrinologists for the treatment of diabetic retinopathy because the RETeval machine (LKC Technologies) is a new tool for screening patients with diabetes for eye disease that can be performed by the primary care physician,” April Y. Maa, MD, of the Atlanta VAMC/Emory Eye Center, (Read more...)

Allergan rejects Valeant exchange offer, makes recommendation to stockholders

Allergan’s board of directors has unanimously rejected Valeant Pharmaceuticals’ unsolicited exchange offer to acquire all outstanding common shares of Allergan, the company announced in a press release.Upon consulting with independent legal and financial advisors, the board determined the offer was “grossly inadequate, substantially undervalues the company, creates significant risks and uncertainties for Allergan stockholders, and is not in the best interests of the company and its stockholders,” according to the release.

Preliminary data indicate Singulair as potential diabetic retinopathy therapy

SAN FRANCISCO — Leukotriene B4 receptor 1 levels, leukotriene B4 generation and superoxide production may be potential pathogenic markers for diabetic retinopathy in young patients with type 1 diabetes, according to study data presented here.The preliminary data also suggested that Singulair (montelukast sodium, Merck), a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor, may be a potential therapy for diabetic retinopathy.

Youth, adult diabetic retinopathy to increase significantly in next decade

Diabetes is a growing problem and is linked to diabetic retinopathy in youth and adults, according to a speaker at the Prevent Blindness Focus on Eye Health National Summit in Washington, D.C.“Obesity is increasing and, unfortunately, that has a relationship to having diabetes and subsequently having diabetic retinopathy,” Neil Bressler, MD, said.