Author: Irv Arons

A Most Memorable Trip: The Soviet Union Before the Breakup – The Interesting Adventures of A Consultant

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...)

A First Trip to Japan: The Interesting Adventures of A Consultant

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...)

My First European Trip: The Interesting Adventures of A Consultant

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...)

The Soft Contact Lens Industry and My Role in its Growth: The Interesting Adventures of A Consultant

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...)

Articles Published in Ophthalmic Journals in 2015

In addition to the several updates posted on this blog in 2015 (see previous posting), I have prepared four articles that have appeared in ophthalmic journals this year.

Here is a brief summary of the four articles, including links to the online versions:
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...)

Blog Articles Published in 2015

2015 was another busy year in writing about new developments in treating retinal diseases. During the year, I published seven blog entries (and another four published articles – to be indexed separately). Here are the highlights of the blog writeups:
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...)

Oraya IRay Update 4: Oraya Therapeutics Receives Guidance for Use in Germany

When I last updated the progress of Oraya Therapeutics, in January of this year (Oraya IRay Update 3: Oraya Now Operating at Nine European Centers and Partnership with Carl Zeiss Meditec), I noted the 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 I reported on the three-year INTREPID safety results, presented the previous September. Here now is the latest information on the progress of the company to bring this adjunctive treatment for the wet form of AMD (Read more...)

Gene Therapy in Ophthalmology Update 22: First Spark Therapeutic Phase III Clinical Trial Results and Phase I Longevity Data

My article updating the latest information on the status of gene therapy clinical trials, What’s New in Gene Therapy for Ophthalmology? was published in the October issue of Retinal Physician. The final draft was submitted just prior to this important news from Spark Therapeutics providing information about their Phase III clinical trial results.
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...)

Using Lasers to Treat Vitreous Floaters: An Update

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...)

A Laser Process for Changing Brown Eyes Blue

`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...)

Avalanche Update 2: Avalanche and Univ. Of Washington Collaborate to Defeat Color Blindness

Avalanche Biotechnologies and the University of Washington Enter Into Exclusive License Agreement to Develop Gene Therapy Approach to Treat Color Blindness
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...)

Oraya IRay Update 3: Oraya Now Operating at Nine European Centers and Partnership with Carl Zeiss Meditec

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...)

Iluvien Update 9: Additional Marketing Approvals; A New Ophthalmic Application; and An Interesting Human Interest Story

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...)

Stem Cells in Ophthalmology Update 28: First Ophthalmic Stem Cell Treatment Recommended for Approval

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...)

Stem Cells in Ophthalmology Update 27: ACT Interim Clinical Results Are Outstanding

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...)

Iluvien Update 8: Alimera Sciences Receives FDA Approval of Iluvien for Treatment of DME

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...)

Retina Revealed

Over the weekend, I read an excellent account of how the various parts of the retina work. Ben Shaberman, the senior science writer for the Eye on the Cure blog (Foundation Fighting Blindness), put together an easy to read and understand overview of what the various cell layers of the retina do and how they interact. Since the retina is the focus of most of what I write about, I asked Ben for his permission to reproduce the writeup in this space. Permission was granted and here is what he wrote:

Stem Cells in Ophthalmology Update 26: First Wet AMD Patient Treated With RPE Derived from iPS Cells

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...)

An Update on Avalanche Biotechnologies: A Potential Longer-Lasting Wet AMD Treatment?

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.
(Editors Note: For a comprehensive look at the company, its people, and technology, please take a look at my original writeup, placed online in late February 2012: A Novel Gene Therapy Approach to Treating the Wet Form of AMD: The BioFactoryTM From Avalanche Biotech.)
Now for the breaking news. On May 5th, in a joint announcement, Avalanche (Read more...)