Author: Irv Arons

Irv Arons

In the summer of 1990, my wife and I were invited to join a People to People Ambassador Tour to visit the Soviet Union. The USSR didn’t break up into its member states until the following year, late 1991. So, we got a look at what turned out to be a huge national facade – a strong military front and a “third world” infrastructure.

I was part of a medical group (medical laser specialists) that visited several hospitals and laser centers (?) within Moscow (Russia), Tbilisi (Soviet Georgia), Kharkov (Ukraine) and in St. Petersburg (again, in Russia). (Read more...)

Irv Arons

In the summer of 1979, I had been hired to conduct a survey of all of the major contact lens companies operating around the world, for a US company interested in finding a partner for its contact lens company. I had completed my interviews of the companies in the US and Europe, and now had to interview the two companies producing lenses in Japan. Since this was my first trip to Japan, I decided to combine business with pleasure and took my wife along to spend a week on vacation, visiting Tokyo and Kyoto, before I was to (Read more...)

Irv Arons

Recall that I had toured Europe in the fall of 1979, visiting the various contact lens companies that were based there, as well as interviewing notable doctors involved in their use, on an assignment to assess the contact lens companies in both the U.S. and Europe for a Japanese client interested in acquiring technology for starting a contact lens business in Japan.

This was my first trip to Europe and I kept a diary of my daily travels – the first and only time I have ever done so. It’s a good thing I did, because there were (Read more...)

Irv Arons

The Bausch & Lomb Soflens, the original soft contact lens, was first approved for marketing in March 1972, My first contact lens assignment began in June of that year, an assessment of the “safety and efficacy” of the Soflens. Over the following fifteen years, I led over 150 assignments involving both soft and gas permeable contact lenses, becoming, in that period, the “guru” of the contact lens industry.

But one of the most interesting assignments, in the fall of 1979, involved my traveling all over the United States and Europe to investigate possible technical partners for a (Read more...)

Regenerating the Retina – February 2015

This article, published in the February 2015 issue of The Ophthalmologist, describes the use of stem cell-derived retinal progenitor cells (RPCs), that are being investigated for reviving/repairing/rejuvenating damaged photoreceptors to bring back sight to those who have lost it due to a retinal degenerative disease, including choroideremeia (CHM), retinitis pigmentosa (Read more...)

Additional Marketing Approvals for Iluvien; A New Ophthalmic Application; and An Interesting Human Interest Story – January 7, 2015

Since I last wrote about Iluvien, Alimera Sciences and pSivida have announced additional marketing approvals for its use in treating chronic DME. The product is now approved for use in fourteen countries, including the U.S. In addition, pSivida is about to (Read more...)

Principal Investigator Stephen R. Russell, MD, of the Stephen A. Wynn Institute for Vision Research at the University of Iowa, presented Phase III data highlighting the rate, breadth and magnitude of changes following administration of SPK-RPE65 to patients with Leber’s Congenital Amaurosis (LCA), at the (Read more...)

Since my first article on the use of a YAG laser to treat floaters (Using Lasers to Treat Vitreous Floaters: Laser Vitreolysis) appeared in this space in August 2010, it has become the most popular/read write-up that I have posted. About 10% of all visitors to my blog come to read that article – and I’ve had over 215,000 unique visitors. One of the most frequent questions I get asked is, is there anyone close to where I live that does the procedure? Since I haven’t kept track of who besides the three doctors I featured in that first (Read more...)

`Don’t It Make My Brown Eyes Blue’ was a smash hit song(1) for Crystal Gale in 1977. But it has been a wish for many a young girl with brown eyes (and even some older ones and perhaps some men) ever since. Over the years it has been possible to turn your brown eyes blue using contact lenses, first lightly tinted ones, which really didn’t do much for dark brown eyes, and later opaque tinted lenses, which would cover brown pigmented eyes and really turn them blue (or green or even other colors), although they created an opaque light eye, (Read more...)

As reported by NPR’s health blog, Shots, on March 25th, Avalanche Biotechnologies in Menlo Park and the University of Washington in Seattle announced a licensing agreement to develop the first treatment for colorblindness. The deal brings together a gene therapy technique developed by Avalanche with the expertise of vision researchers at the University of Washington.

“Our goal is to be treating colorblindness in clinical trials in patients in the next one to two years,” said Dr. Thomas Chalberg, (Read more...)

The last time I checked in on Oraya, in March 2013 (Oraya IRay Update 2: INTREPID Two-year Results Meet Primary Clinical Endpoint – Results in At Least 35% Fewer anti-VEGF Injections), the company had just announced the two-year results of the INTREPID clinical study, showing favorable results in requiring fewer anti-VEGF treatments to treat wet AMD.

With the recent announcement (January 7, 2015) of a collaboration agreement between Oraya and Carl Zeiss Meditec, to provide funding to Oraya over a period of up to two years for the implementation of Oraya’s growth strategy, and a report of the (Read more...)

Since I last wrote about Iluvien back in September (Iluvien Update 8: Alimera Sciences Receives FDA Approval of Iluvien for Treatment of DME), when Alimera Sciences and pSivida announced the FDA approval of Iluvien for treating chronic DME, adding the U.S. to the approvals or pending approvals obtained in seventeen European countries – approved in thirteen and pending approval in an additional four others, the product has become commercially available in the UK and Germany and is scheduled to become available in Portugal shortly.

With the FDA approval, Iluvien should also become commercially available in the U.S. in (Read more...)

On December 19th, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended the stem cell product Holoclar (Chiesi Farmaceutici S.p.A.)  as a first-ever medicinal treatment for severe limbal stem cell deficiency, a condition caused by physical or chemical burns to the eye or eyes in adults, which can result in blindness.

The EMA has designated Holoclar as both an orphan medicine and an advanced therapy medicinal product, which enabled the manufacturer to receive free scientific advice and protocol assistance for drug development. The CHMP recommendation was based on an assessment by the expert (Read more...)

Having treated 36 patients in two clinical trials for Stargardt’s Macular Dystrophy (SMD – 24 patients to date) and for dry Age-Related Macular Degeneration (AMD – 12 patients to date), Advanced Cell Technology reported the interim results obtained with 18 of these patients (9 in each trial) in the US-based studies. Both trials (NCT01345006 – Stargardt’s, and NCT01344993 – AMD) began in July 2011, giving the company up to three-year’s data for the earliest patients, and a median of 22 months followup for all. The interim results were reported in The Lancet, published online October 14, 2014 in: “ (Read more...)

After several attempts to gain approval for its NDA for Ilunien, the FDA has finally seen the light (after approval in the UK, Germany, and marketing or pending approvals in seventeen other EU countries).

I first began writing about Iluvien in July 2010 – see my comprehensive writeup about the technology behind this and other sustained delivery drug systems – Iluvien and the Future of Ophthalmic Drug Delivery Systems. In addition I have written about the products progress in seven updates, the latest in August 2012, Iluvien Update 7: Alimera Sciences to Re-File for FDA Approval of Iluvien for (Read more...)

By Ben (Read more...)

Earlier this week, it was reported that Masayo Takahashi, an ophthalmologist at the RIKEN Center for Developmental Biology (CDB) in Kobe had appeared in front of a 19-member health-ministry committee for the safety of the clinical use of stem cells. She was flanked by Shinya Yamanaka, the biologist who first created iPS cells. Yamanaka shared the 2012 Nobel Prize in Physiology or Medicine for his breakthrough and now heads the Center for iPS Cell Research and Application in Kyoto. Takahashi was seeking approval to implant a retinal pigmented epithelial (RPE) sheet made from induced pluripotent stem (iPS) cells into a (Read more...)

There is breaking news this week about Avalanche Biotechnologies and I would like to share it, as well as a brief update on the clinical trial underway using their proprietary gene therapy approach to treating the wet form of AMD.

Now for the breaking news. On May 5th, in a joint announcement, Avalanche (Read more...)