Tuesday, September 22, 2009

Endoscopy in Ophthalmology: The Latest News and Some History

I saw a brief writeup in the current OSN Supersite (September 22, 2009) about Endo Optiks launching a new series of high-resolution micro-endoscopes and it brought to mind the first time I learned and wrote about this company.

I first learned about video endoscopic techniques being used in ophthalmology in the Spring of 1991. At that year’s ASCRS Meeting I learned about Summit Technology’s OmniView and at the Fall AAO Meeting, about Escalon’s InnerView.. In the Summer of 1992, I learned about the newest technology in this field, to be introduced at that Fall’s AAO Meeting, the MicroProbe video endoscope from Endo Optiks. The story about these endoscopes was published in the October 15, 1992 issue of Ocular Surgery News.

I thought that some of you might be interested in both the latest news and a little bit of history.

Here is the latest news from Endo Optiks, followed by the original writeup published in October 1992.

Endo Optiks launches series of high-resolution micro-endoscopes

LITTLE SILVER, N.J. — Endo Optiks has added a new series of high-resolution micro-endoscopes to its existing endoscopes line, providing improved image quality and increased field of view, according to a press release from the company.

"We designed the new high-resolution scopes to help surgeons better visualize the anatomy of the eye," Martin Uram, MD, endoscope creator and co-founder of Endo Optiks, said in the release. "Surgeons will find improved visualization when performing endoscopic cyclophotocoagulation, panretinal photocoagulation and diagnostics."

Two new versions have been launched: the Triple Function Micro-Endoscope and the Dual Function Micro-Endoscope. Both combine light and imaging, but the Triple Function Micro-Endoscope model also offers laser, the release said. The Triple Function Micro-Endoscope has a 19-gauge probe, while the Dual Function Micro-Endoscope has a 20-gauge probe.

The high resolution of the devices is a 70% increase in pixels from the company's existing scopes, from the current 10,000 pixels to a 17,000 pixel fiber optic bundle, the release said.

In addition, the devices offer an expanded 160̊ field-of-view.

Source: OSN SuperSite 9/22/09

Original writeup as submitted July 17, 1992 to Ocular Surgery News and published in the October 15, 1992 issue:

Technology Update


Irving J. Arons
Ophthalmic Consulting Group
Arthur D. Little

It was inevitable that video endoscopic techniques, now widely practiced in general laparoscopic/endoscopic surgery, should finally reach ophthalmology. True, most inner parts of the eye are readily viewed through the pupil and minimally invasive surgery has been a part of the ophthalmologist's armamentarium for some time, but certain parts of the eye are not easily viewed, much less treated, and this new technology seeks to correct this oversight. With the new technology, eye structures such as the back of the iris, the ciliary body, the far reaches of the retina, and sites at or near the zonule attachment points can now be clearly seen and treated. Further, with the magnification and visual detail available with today's video endoscopic equipment, enhanced views of cellular level structures are now possible for other areas of the eye as well.

Over the past two years, at least two video endoscopic techniques have been introduced into ophthalmology. At the 1991 ASCRS meeting, Summit Technology announced its OmniView, an ophthalmic fiberendoscopic system containing between 50 to 70 illuminating fibers surrounding an image guide, all bundled into an 0.8 mm probe. It was introduced for viewing of sutures placed into the ciliary body, for inspection of the integrity of the posterior capsule, and to verify IOL haptic placement. Other applications suggested were for viewing retinal and glaucoma surgery, for otolaryngology, lacrimal duct surgery and for neurosurgery. Summit expected to sell the system for about $18,000.

The second ophthalmic endoscopic system was InnerView, launched by Escalon Ophthalmics at last fall's AAO meeting. This again is a small (20 gauge, 0.9 mm) flexible endoscope probe that can be coupled to a high resolution video display. Although the price had not been fixed at the time of introduction last fall, it was estimated that the system would sell for between $16,000 to $18,000 complete.

However, the newest endoscopic technology, to be launched at this fall's Academy Meeting, is the MicroProbe, an integrated diode laser treatment device combined with a high resolution microendoscope. The new device is from Endo Optiks, a two-year old Little Silver, NJ startup company, founded by Dr Martin Uram, a retinal surgeon in New Jersey. Endo Optiks has been able to couple an endoscopic viewing system with a diode laser and is working on incorporation of an aspirator system, all into a 20 gauge (0.89 mm) probe that can both view and treat formerly inaccessible parts of the eye. Further, with its high resolution color capabilities, the system can be used for diagnosis of difficult to view intraocular structures.

The heart of the system is a unique, patented, lens delivery system that combines a high illumination light source, a high resolution video endoscopic pickup, and a 0.1 to 2 watt 810 nm diode laser photocoagulation delivery system, all contained within a 20 gauge probe. This will allow the surgeon to view and treat a variety of eye structures including the peripheral retina, the pars plana, ciliary body and the posterior aspects of the iris in vivo.

The MicroProbe consists of a compact console containing the light source, the high resolution video monitor, a VCR recorder, the aspirator pump, the diode laser (including a red diode aiming beam), and simple keyboard controls. The system has been undergoing clinical evaluation trials, has received 510 (k) marketing clearance, and will be officially launched at this years AAO Meeting (1992) in Dallas.

By integrating the viewing and treating modalities into a 20 guage handpiece, the new system is truly a breakthrough in ophthalmology. In addition to viewing and treating the peripheral retina and ciliary processes, the unique system can be used for up close and personal diagnoses of other eye structures, giving high resolution colored views of the retina, lens, iris, and other ocular structures (and implants).

The primary application for the new device is expected to be for retinal surgeons for performing all types of vitreoretinal procedures. However, it is expected that glaucoma specialists will also find use for the device in pursuing direct visualization and laser treatment of the ciliary processes, as an alternative treatment for intractable glaucoma. The technology holds great promise for use in other medical fields as well. It is anticipated that the MicroProbe integrated endoscopy and laser system will sell for between $50,000 to $60,000 when it comes to market this fall.

Monday, September 14, 2009

Avastin/Lucentis Update 25: Comparative Studies Proliferate – France Joins the Fray

According to a story just published in APM Health Europe (September 14, 2009), a French study comparing Roche's Avastin (bevacizumab) and Novartis' Lucentis (ranibizumab) in the treatment of wet age-related macular degeneration (AMD) has enrolled its first patients.

The U.S. CATT Study (Comparison of Age-Related Macular Degeneration Treatment Trials) was launched in February 2008, and a U.K. study is also underway as well as similar studies being carried out in Austria, Germany and Spain.

In France, Professor Gisèle Soubrane of the Creteil hospital outside Paris suggested a comparative study as early as 2006 but failed to secure financing. Early in 2008, the Lyon group of hospitals (HCL) put forward a new protocol and applied for financing. There were various delays and setbacks but the GEFAL (Groupe d'Evaluation Français Avastin versus Lucentis) study is now underway.

The study is sponsored by an academic hospital in Lyon (Hospices Civils de Lyon), the government (via a national research founding program), and the national health insurance system (which reimbursed for Lucentis).

The first recruiting centre in Lyon enrolled an initial patient at the end of June. Contacted by APM last week, Professor Laurent Kodjikian of HCL said: "We have now enrolled 10 patients and by autumn we shall have at least 40 centres."

The GEFAL study is due to enroll 600 patients over a period of 12 to 18 months and they will be monitored for one year.

The French health products safety agency (Afssaps) has been notified that the study involves 46 centres (34 hospitals and 12 private centres).

The study will evaluate the safety and efficacy of Avastin. Provided Avastin is shown to be comparable to Lucentis, the findings should bring down the cost of AMD treatment. This is important since the disease affects elderly people, a population group set to increase.

According to IMS Health figures published in July, in 2008, Lucentis was the 15th most sold drug in France. Turnover was just below 150 million euros. Sales practically tripled between 2007 and 2008.


Contacted by APM on the off-label use of Avastin since July 2006, Afssaps initially responded by saying it was not in a position to control such use and said it did not intend to communicate with doctors on the matter but later decided to look into the problem.

On Thursday, Afssaps published an information sheet on the off-label use of Avastin, drawing attention to the fact that in its current pharmaceutical form, the product is not adapted to intravitreal administration (insufficient stability data, etc.) and pointing out that the safety data on the use of Avastin in ophthalmology are limited.

The agency says adverse effects with the off-label use of Avastin have been "under-notified" but notes the risk of endophthalmitis/uveitis linked with the injection, and risk of tearing or detachment of the pigment layer of the cornea. Cases of thrombotic side-effects have also been reported.

The agency points out that other products have been authorised for the treatment of wet AMD. Until the results of the GEFAL study and others are available, Afssaps recommends caution in the use of intravitreal Avastin.

Reported by: Sylvie Lapostolle

With the AAO Meeting coming up next month, I expect to hear about the first results of the CATT Study, and perhaps more from some of these other comparative studies as well.

Stay tuned and I will continue to update findings on both the drugs and other technologies for treating AMD.