Avastin/Lucentis Update 37: The Controversy Continues – Genentech “Paid to Play”

As I read the news release from the NEI/NIH yesterday morning, about the one-year results of the clinical trial evaluating the combination use of Lucentis with pan-retinal laser therapy to treat diabetic macular edema, prior to posting it online, and later, when I read the complete study as posted in Ophthalmology, the one thought that kept running through my mind was, why was Lucentis, at $2000 per dose chosen for the study, rather than Avastin at $50 per dose?

And then I found out, when Andrew Pollack wrote the story behind the story later in the afternoon in the New York Times, “A Genentech Eye Treatment is Found to Help Prevent Vision Loss in Diabetics”.

As quoted in the NY Times story, from Dr. Philip Rosenfeld of Bascom Palmer in Miami, “the decision was ‘clearly a case of pay to play’ since Genentech’s money dictated the choice of drugs.”

Organizers of the trial conceded that a major reason Lucentis was chosen was that Genentech agreed to provide the drug for free and contributed $9 million in additional financing – but only if Lucentis was used!

"Obviously you can't underplay $9 million," said Dr. Ferris of the National Eye Institute, which is part of the part of the National Institutes of Health. But he said there were other factors as well, like a belief that Lucentis might have been the better drug.

As shown in the study, nearly half the people whose eyes were treated with Lucentis, often in combination with standard pan-retinal laser therapy, had an improvement in vision of at least two lines on an eye chart after one year. That compared with only about 30 percent of those receiving laser therapy alone. And fewer people treated with Lucentis experienced a big loss of vision.

"This is the first new treatment for people with diabetic macular edema in a quarter of a century," Dr. Frederick L. Ferris III, clinical director of the National Eye Institute, which sponsored the trial, said in a telephone news conference on Tuesday.

The trial involved 691 patients, some of whom had both eyes treated, resulting in 854 total eyes. There were four treatment groups: One group got Lucentis injections into the eye as often as every four weeks, plus laser therapy. Another got Lucentis, with laser therapy used only after six months and only if needed. The third group got laser therapy plus injections into the eye of triamcinolone, a steroid sold by Allergan under the name Trivaris. The fourth group got laser therapy plus a sham injection.

(For more on the trial, see my posting of yesterday’s news release from NEI/NIH. There is also a link included to the full writeup of the clinical trial in the journal Ophthalmology.)

Some doctors criticized the organizers of the trial for testing Lucentis rather than the other Genentech drug, Avastin, which works in the same way as Lucentis. Avastin, approved for use in treating colon cancer is not approved for use in the eye, but has been used “off-label” since early 2005 and, because of its lower cost and anecdotal results and a few comparative studies, appears to work as well as Lucentis. According to Market Scope, an ophthalmic market research company, more than 60% of intraviteal injections used in treating AMD are done with Avastin, rather than Lucentis, probably because of the cost differential.

As stated in the NY Time article, Avastin is undercutting sales of Lucentis, which totaled $1.1 billion in the United States last year.

It is interesting to note that Genentech refused to supply either of the drugs or support the clinical trial, when the NEI/NIH agreed to fund a comparative study of the two drugs in treating neovascular AMD, the CATT Study (Comparison of Age-Related Macular Degeneration Treatment Trials). The CATT Study was initiated, without Genentech aid in February 2008, finished recruiting its 1200 patients in November 2009, and will report initial results in early 2011.

It will be interesting to see what the effect on sales of Lucentis will be if the CATT Study shows little or no difference in the two drugs in the treatment of AMD.

Combination of Lucentis Plus Pan-Retinal Laser Achieves Vision Gain in Diabetic Macular Edema

A news release from the NEI/NIH describes how researchers have shown that the combination of retinal lasers used with Lucentis are more effective in improving vision in the treatment of diabetic retinopathy that either lasers or drugs alone. The study’s one-year results were published today in Ophthalmology.

Comparative-Effectiveness Study Confirms New Treatment for Diabetic Macular Edema  Ranibizumab Injections Plus Laser Therapy Results in Dramatic Visual Improvement

Researchers have shown that ranibizumab (Lucentis) eye injections, often in combination with laser treatment, result in better vision than laser treatment alone for diabetes-associated swelling of the retina.

Laser treatment alone has been the standard care for the past 25 years. But nearly 50 percent of patients who received this new treatment experienced substantial visual improvement after one year, compared with 28 percent who received the standard laser treatment. The study involved 52 clinical sites within the Diabetic Retinopathy Clinical Research Network (DRCR.net), supported by the National Eye Institute (NEI) and the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health.

“These results indicate a treatment breakthrough for saving the vision of people with diabetic macular edema,” said Neil M. Bressler, M.D., chair of the DRCR.net and chief of the Retina Division at the Wilmer Eye Institute, Johns Hopkins University, Md. “Eye injections of ranibizumab with prompt or deferred laser treatment should now be considered for patients with characteristics similar to those in this clinical trial.”

Diabetic retinopathy is the most common cause of vision loss in working-age Americans. This condition damages the small blood vessels in the eye’s light-sensitive retinal tissue. When these damaged blood vessels begin to leak fluid near the center of the retina, known as the macula, macular edema occurs. The macula provides detailed central vision used for activities such as reading, driving, and distinguishing faces. In macular edema the retinal tissue swells, which can lead to vision loss if left untreated.

Laser treatment of the retina has been the standard care for diabetic macular edema since an NEI-supported study in 1985 showed it to be beneficial. However, recent small short-term studies have revealed the visual benefits of eye injections of medications that block a chemical signal that stimulates blood vessel growth, known as vascular endothelial growth factor (VEGF). These studies have indicated that repeated doses of anti-VEGF medications, such as ranibizumab, may prevent blood vessels from leaking fluid and causing macular edema. The DRCR.net study, published online April 27 in Ophthalmology, confirms preliminary results and provides evidence of the treatment’s effectiveness in combination with laser therapy through at least one year of follow up.

“This comparative-effectiveness study demonstrated that a new treatment can protect and, in many cases, improve the vision of people with diabetic macular edema,” said NEI Director Paul A. Sieving, M.D., Ph.D.

The current study included a total of 854 eyes of 691 people, who had one or both eyes treated. Participants, who were on average in their early 60s, were diagnosed with type 1 or 2 diabetes and macular edema. They were randomly assigned to one of four study groups: sham injections plus prompt laser treatment within one week; ranibizumab injections plus prompt laser treatment; ranibizumab plus deferred laser treatment after six months or more; or injections of corticosteroid medication known as triamcinolone (Trivaris) plus prompt laser treatment.

Ranibizumab injections could be given as often as every four weeks, and triamcinolone injections or laser treatments could be given as often as every 16 weeks. In general, treatment was continued until a participant’s vision or retinal thickness returned to normal, or additional treatment did not improve vision or retinal swelling.

After one year, nearly 50 percent of eyes treated with ranibizumab and prompt or deferred laser treatment showed a substantial visual improvement. People could read at least two additional lines on an eye chart with the treated eye, or letters that were at least one-third smaller than they could read before the study treatment. Fewer than 5 percent of eyes in these groups experienced a visual loss of two or more lines. The results were similar whether patients received prompt or deferred laser treatment with the ranibizumab injections.

Mean Change in Visual Acuity at Follow-up Visits

In contrast, about 30 percent of eyes that received laser treatment alone or triamcinolone plus laser showed a visual improvement of two or more lines on an eye chart, while 13 to 14 percent of eyes in these groups had a visual loss of two or more lines.

Although participants in all three injection groups had a greater decrease in retinal thickness after one year than with laser treatment alone, patients who received triamcinolone injections had greater complication rates. About 30 percent of people in the triamcinolone group developed high eye pressure that required medications, and about 60 percent developed cataracts that required surgery.

Few participants who received eye injections of ranibizumab had eye-related complications, such as an infection inside the eye likely caused by the injections, or worsening of a retinal detachment that existed prior to beginning treatment. The study found that eye injections of ranibizumab were not associated with any serious risks such as heart attack or stroke. DRCR.net researchers will continue to monitor the study participants for at least three years to obtain additional information about the safety and effectiveness of these macular edema treatments.

Find more information about this clinical trial (NCT00444600) at www.clinicaltrials.gov.

For the complete study as published in Ophthalmology, use this link.

AMD Update 10: An Overview of Current Anti-VEGF Treatments for Neovascular (Wet) AMD

I recently read this excellent overview of current treatment protocols for anti-VEGF treatments of wet AMD in the April issue of Refractive Eyecare, and asked the author and publishers for permission to reproduce it in this space. Permission was granted, and I hope you find it as interesting and well written as I did.

New Uses of Anti-VEGF Agents for the Treatment of Neovascular AMD

Dante J. Pieramici, MD

Refractive Eyecare April, 2010

To boost the efficacy and duration of anti-VEGF therapy, researchers are evaluating new dosing regimens, higher drug doses, and new medications.

While current anti-VEGF drugs constitute an effective therapy for neovascular age-related macular degeneration (AMD), they are not a magic bullet. Their main shortcoming is their relatively brief duration of effect, which means that patients must receive monthly intravitreal injections; in addition, the efficacy of current anti-VEGF drugs leaves room for improvement. Clinicians and researchers are therefore continuing to explore the use of new treatment regimens, combination therapies, and higher drug doses. In addition, one new drug is currently in clinical trials and more are undergoing preclinical investigations.

To test these new options, a number of studies are currently underway, including the HARBOR trial, the VIEW 1 and VIEW 2 studies, and the CATT study (See box). While none of these studies is complete, many are fully enrolled and should be providing clinicians with valuable data in the near future.

New Treatment Protocols

Anti-VEGF drugs are effective when administered monthly, but the need for such frequent intravitreal injections places a high treatment burden on the patient and increases the risk of intraocular infections and other complications. For this reason, several studies are examining alternative treatment protocols to see if they can maintain efficacy while decreasing the frequency of injections. (See box 2)

In the PrONTO study, researchers administered ranibizumab (Lucentis) monthly for 3 months and then "as needed" (PRN) for the remainder of the study. During the first year of the study, patients were retreated when optical coherence tomography (OCT) showed an increase in central retinal thickness of at least 100 microns or when visual acuity testing showed a loss of 5 or more letters; during the second year of the study, a qualitative increase in the amount of fluid was also included as one of the retreatment criteria. Using this approach, researchers achieved a mean increase in visual acuity of 11.1 letters and a mean decrease in central retinal thickness of 212 microns with an average of only 9.9 injections over 24 months.(1)

Another way of trying to stretch the interval between intravitreal injections is by using a treat-and-extend protocol. Unlike a PRN dosing schedule, in which patients are monitored monthly even if they are treated less frequently, a treat-and-extend protocol stretches the interval between appointments. Using such a strategy, the patient is treated at every visit, but the time between visits is gradually increased if the patient's condition remains stable – i.e., no signs of vessel leakage, increasing edema, decreasing visual acuity, or blood or lipid on exam. In most cases, this approach reduces the number of injections by approximately 50% over a 1-year period.

[Editors Note: This is a case where the Notal Vision at home monitor, when it becomes available, could prove valuable in extending treatment time for neovascular AMD patients.]

Finally, researchers are also considering the use of photodynamic therapy (PDT) as an adjunct to anti-VEGF injections. Although combination therapy does not seem to improve overall treatment efficacy, early data suggests that combining PDT with anti-VEGF medications may allow clinicians to achieve the same results with fewer injections. Because PDT adds another level of complexity to the treatment, however, it has not been widely adopted by clinicians.

Higher Doses and New Drugs

While PRN dosing, treat-and-extend protocols, and combination therapy can all help to prolong the duration of efficacy for existing anti-VEGF drugs, new drug formulations also hold promise. To test whether using a higher concentration of drug can provide additional benefit, researchers are currently studying high-dose ranibizumab. Other studies are testing novel agents such as VEGF-Trap to see if they provide greater efficacy and/or duration of effect.

In the HARBOR trial, researchers are comparing the standard 0.5 mg dose of ranibizumab with a 2.0 mg dose to see whether injecting more of the drug will improve its efficacy and extend its duration of effect. Both doses are being evaluated using a PRN dosing schedule as well as a fixed monthly schedule, so this trial should also yield information about the interaction between dose and dosing frequency.(2)

In terms of side effects, higher drug doses pose a few potential risks. Injection-related complications are a risk with any intravitreal drug, but these risks should be largely independent of the dose; since the high-dose formulation of ranibizumab is more concentrated than the low-dose formulation, clinicians can inject the same volume for both treatment groups. Thrombotic events such as heart attacks and strokes will be a concern, but the systemic drug levels should be significantly lower than those achieved following systemic administration of Avastin to treat cancer – by a factor of 100.

In addition to the HARBOR trial, other major studies that should soon yield interesting results include the VIEW 1 and VIEW 2 studies, both of which are evaluating a new anti-VEGF agent, VEGF-Trap. Unlike ranibizumab, which is an antibody (Fab) fragment against VEGF, VEGF-Trap is a soluble receptor for VEGF. VEGF-Trap has a higher binding affinity than ranibizumab, which may improve its efficacy and/or duration of effect. VEGF-Trap also blocks platelet-derived growth factor (in addition to all isoforms of VEGF), which may provide some additional anti-angiogenic properties.

Future Directions

Because drug development moves slowly through multiple phases, treatment for neovascular AMD over the next few years will be limited to drugs that are currently available – ranibizumab and bevacizumab – plus VEGF-Trap, which is well along in clinical trials. However, there are numerous agents in the pipeline that are being evaluated in preclinical and phase 1 trials. While we cannot predict which of these agents might prove clinically useful, the range of options undergoing study holds out the promise that one or more of these will prove effective.

Finally, I believe the future of AMD treatment will involve a shift from treatment of neovascular AMD to earlier detection and treatment of non-neovascular AMD. Specifically, researchers are currently examining ways to block inflammation, inhibit oxidation, and rescue photoreceptors. If such treatments are successful, then we might be able to prevent neovascular AMD from occurring.

The Bottom Line

While anti-VEGF drugs are usually effective in the treatment of neovascular AMD, researchers and clinicians are still looking for ways to improve treatment. Since monthly intravitreal injections place a high treatment burden on patients, some studies are examining ways to increase the interval between treatments-such as PRN dosing, treat-and-extend protocols, and combination therapy. In addition, studies are examining the efficacy of other therapies that might offer greater efficacy and/or duration of effect, including high-dose ranibizumab and VEGF-Trap.

Dante J. Pieramici, MD, is a retina specialist at California Retina Consultants, director of the California Retina Research Foundation, and a clinical assistant professor at the University of Southern California's Doheny Eye Institute. He is a consultant for Genentech, Novartis, QLT, and CoMentis.

Refractive Eyecare’s managing editor Kay Downer assisted in the preparation of this manuscript.

References

1. Lalwani GA, Rosenfeld PJ, Fung AE, et al. A variable-dosing regimen with intravitreal ranibizumab for neovascular age-related macular degeneration: year 2 of the PrONTO Study. Am J Ophthalmol. 2009 Jul;148(1):43-58.

2. A Study of Ranibizumab Administered Monthly or on an As-Needed Basis in Patients With Subfoveal Neovascular Age-Related Macular Degeneration (HARBOR).

Additional Reading

For more on the Notal Vision at home AMD monitor, please see my writeup: Notal Vision: The ForeseeHome AMD Monitor and It’s Potential to Save Vision – A First Report

In addition, the April 25th issue of Ocular Surgery News contains an article on the same subject: Combination Therapy May Augment Anti-VEGF Activity. It mentions other clinical studies underway for combination therapies and to extend the time between intravitreal injections, including the use of radiotherapy.

AMD Update 9: Notal Vision’s AMD Home Monitoring Device Officially Joins AREDS2 Clinical Trial

Beginning in May, the NEI/NIH will begin recruiting 1000 patients in a cohort study, from among those participating in the AREDS2 clinical trial. Half of the recruits will be provided the Notal ForeSeeHome Device to monitor their progression from mid-to late-stage dry AMD to neovascular, or wet-stage AMD, while the other half will monitor their progress using standard care, including the Amsler Grid.

The overall objective of this two arm randomized clinical trial (RCT) is to determine if home monitoring of participants at high risk of progression to neovascular AMD, using the comprehensive visual field and telemedicine solution based on the ForeseeHome Device in AREDS2 (referred to as the ForeseeHome comprehensive solution), improves detection of progression to choroidal neovascularization (CNV) when compared with standard care (use of the Amsler Grid).

The primary outcome of this study will be to present best corrected visual acuity (BCVA) at the time of CNV diagnosis. Secondary outcomes include time to confirmed CNV diagnosis, lesion size, lesion location (extrafoveal, juxtafoveal, or subfoveal), lesion type (occult without classic, predominantly classic or minimally classic), sensitivity and specificity, and BCVA following three consecutive months of treatment and twelve months after the initial start of CNV treatment with an intravitreal anti-VEGF agent using either ranibizumab or bevacizumab.

A further secondary outcome will be to determine if vision can be preserved by earlier detection of CNV as compared to its detection at a later stage with standard care.

The study is planned to run for two years and is expected to be completed by December 2012.

(For additional information about Notal Vision and my comprehensive writeup about the ForeseeHome Device, please see: Notal Vision: The ForeseeHome AMD Monitor and It’s Potential to Save Vision – A First Report)

The official name of the clinical trial cohort is:

Home Vision Monitoring in Age-Related Eye Disease 2 (AREDS2) for Progression to Neovascular Age Related Macular Degeneration (AMD) Using the ForeseeHome Device

(A link to the web page containing additional information about the cohort study is provided above.)

Outcomes will be ascertained via the following specific aims:

Arms, Groups and Cohorts in this Clinical Trial

* : Device monitoring arm

o participants in the device monitoring arm will receive a packed device at home, with instructions to install and connect the device to a modem as well as instructions for daily use of the device.

* : Standard care (control) arm

o Standard care instruction per clinic routine for home vision monitoring (Amsler Grid) to detect progression of AMD.

Inclusion Criteria:

* Participants will be enrolled over a 9 to 12-month period and must meet the following criteria:

* 1. Male or female Age-Related Eye Disease 2 (AREDS2) participant 55 years of age or older who is actively being followed in AREDS2 and is expected to continue until the end of AREDS2.

* 2. Participant must be English speaking and understand and sign the protocol's informed consent document.

* 3. Participant does not have advanced AMD (neovascular AMD or central geographic atrophy) in at least 1 eye. The eye(s) that does not have advanced AMD must have at least intermediate AMD and will be the study eye(s).

* 4. Participant must be able to successfully demonstrate their ability to comprehend instructions and use of the ForeseeHome device (a ForeseeHome device will be available at the clinic for the participant to demonstrate their ability).

* 5. Participant must have a working phone land line in the participant's main residence.

* 6. Participant's address to which the ForeseeHome device will be sent, if randomized to the device monitoring arm, must be located in the U.S.A.

* 7. Study eye(s) must have best corrected visual acuity 20/60 or better (at least 54 letters).

* 8. Ocular media sufficient to allow adequate quality fundus photography.

* 9. Participant must be willing to have name and contact information provided to Notal Vision. Participants may be contacted as part of the study

* 10. Participant must consent to be examined by the study ophthalmologist when changes in symptoms are detected by the home-device or by standard of care or when unreliable test results occur during the usage period.

* 11. If randomized to the device monitoring arm participant must take the device with them if staying somewhere else other than their primary residence for 7 days or more.

* 12. Participant has some experience using a computer.

Exclusion Criteria:

The following are exclusion criteria for prospective study participants:

* 1. Participant has evidence of macular or retinal disorders other than AMD in the study eye(s).

* 2. Participant has known adverse reaction to fluorescein dye.

* 3. Participant is seen at the clinic more frequently than every 4 months.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Notal Vision Ltd

Overall Clinical Trial Officials and Contacts

Emily Chew, MD Study Chair National Eye Institute (NEI)

Overall Contact: Osnat Ehrman, MSc 952-334-5797 osnat@notalvision.com

ELLEX 2RT Retinal Regeneration Laser: An Update – First Clinical Results

In November 2007, just prior to that year’s AAO meeting, I learned about a new laser that had the potential to alleviate the early stages of age-related macular degeneration and other retinal diseases including diabetic maculopathy, caused by compromised Bruch’s membrane. The laser-based therapy was called ELLEX’s 2RT (Retinal Regeneration Therapy).

The theory behind the therapy was based on research conducted by Professor John Marshall at St. Thomas’ Hospital of London, and his colleague Dr. Ali Hussain. They found, after experimentation, that a specially-built Q-switched doubled YAG laser (532 nm) operating at 3 ns pulses, could be used subthermally to trigger a renewal process of the retinal pigment epithelial (RPE) cells, a sort of biostimulation, without damaging the overlying retina, including photoreceptors. This caused the RPE to migrate and release matrix metalloproteinases, enzymes, which act to clean up Bruchs membrane. The scientists were able to demonstrate and measure Bruch’s ability to transport water and chemicals and thus rejuvenate the retina.

      

For the rest of the story, please see my complete initial report of November 2007. (Link at the end of this post.)

First Clinical Results

In November 2008, Ellex released the six-month clinical study results of the first trial. In this clinical study, conducted at St. Thomas’ Hospital in London by Professor John Marshall, 23 patients (38 eyes) with newly-diagnosed diabetic maculopathy and/or macular edema were recruited and treated with Ellex 2RT. Seventeen patients (28 eyes) completed the six-month follow-up examination.

Patients are being followed for one year. Postoperative testing includes optical coherence tomography and microperimetry.

At the six-month follow-up, for the17 patients (28 eyes), the LogMar visual acuity had improved by two or more lines in 43% of eyes and between one and two lines in 28%. It remained unchanged in 15% of eyes, and deteriorated by two or more lines in 14%. Central macular thickness decreased by more than 5% from baseline in 46% of patients, remained stable in 39%, and had an increase of more than 5% in 15% of patients. The number of hard exudates decreased in 41% of eyes, stayed stable in 43%, and increased in 16%. Vascular leakage decreased in 55% of eyes, was unchanged in 31%, and increased in 14%. Slit-lamp ophthalmoscope microperimetry confirmed that photoreceptor function was not affected by the laser treatment. No adverse effects occurred during the study period.

The six-month results show that Ellex 2RT is clinically safe and effective in the treatment of macular edema secondary to diabetic retinopathy.

An example of the minimal damage to retinal cells is shown in the following illustration of 2RT treated Porcine RPE:

Research Program Update (April 2010)

Since the release of preliminary clinical results in 2007 and of the six-month results in 2008, Ellex has initiated a series of pilot clinical studies aimed at evaluating the clinical efficacy of Ellex 2RT for a number of indications, the most important of which is age-related macular degeneration (AMD). The studies are making good progress, with eight prototype systems currently in use throughout Australia and the United Kingdom in these studies. Patient recruitment is nearing completion in two of the key pilot studies, with follow-up planned over a 12-month period.

Studies focused on diabetic macula edema (DME) and proliferative diabetic retinopathy (PDR) are being undertaken in collaboration with the Royal Adelaide Hospital at three study sites. A major benefit of these studies is that they include control groups, allowing Ellex to more accurately benchmark the effect of Ellex 2RT treatment against conventional laser treatment.

A third study, focused on early AMD treatment, is being undertaken in collaboration with the Royal Victorian Eye and Ear Hospital, a major Australian teaching institution, under Professor R. Guymer.

Ellex will present preliminary results from these studies at the 2010 ARVO meeting in May. Once the results from this round of pilot studies have been fully analyzed, the company will evaluate the opportunity to undertake a multi-center randomized study, and look to expand their study sites beyond Australia and the UK.

In addition, as announced earlier this month, Ellex has sublicensed the SRT (selective retinal therapy) patent, U.S. 5,549, 596, from Massachusetts General Hospital, and can now enter the U.S. market with this technology.

(For more information on this development, please see my report: AMD Update 8: Breaking News – Ellex Sublicenses SRT Patent, linked at the end of this report.)

References:

Press Release: Ellex Announces Six-Month Results on Retina Regeneration Therapy, November 2008

Can Early Laser Therapy Delay Disease Progression?, John Marshall, Retinal Physician, September, 2009.

Links:

Ellex 2RT Retina Regeneration Therapy: A First Report (November 2007)

AMD Update 8: Breaking News -- Ellex Medical Sublicenses SRT Patent

(April 2010)

AMD Update 8: Breaking News -- Ellex Medical Sublicenses SRT Patent

Ellex Medical, the company behind the Ellex 2RT Retinal Regeneration Therapy for treating AMD, announced today that it had sublicensed Mark Latina’s SRT (selective retinal therapy) patent, to allow it to market its 2RT treatment in the United States.

This same patent by Dr. Latina, is the basis for his SLT (selective laser trabeculoplasty) and SRT therapies. The patent, Selective Laser Targeting of Pigmented Ocular Cells (U.S. Patent 5,549,596) was issued by the Patent Office on August 27, 1996 and assigned to Massachusetts General Hospital.

Under the terms of the agreement, Ellex has been granted non-exclusive rights to the retinal aspects of the SRT patent.

Lumenis also holds rights to this patent for the marketing of both its SLT and SRT lasers.

Previously, Ellex had been prevented from entering the US market with Ellex 2RT due to this patent; however, with the sublicense agreement now in place Ellex customers in the US will be able to use Ellex 2RT for the treatment of retinal disease.

The Intellectual Property (IP) pathway for Ellex 2RT is unencumbered outside of the US, and the Company has filed for four international patents related to the Ellex 2RT Program.

Ellex CEO, Mr. Simon Luscombe, said that the sublicense agreement was a major milestone, allowing the Company to proceed with a definitive plan to launch Ellex 2RT in the US market.

“The next phase of the Ellex 2RT Program will focus on undertaking further clinical trials, and on obtaining key regulatory approvals for the Ellex 2RT product range”, commented Mr. Luscombe.

For a comparison of the three selective tissue lasers marketed under this patent by Lumenis and Ellex, please see the following table:

Recommended Further Reading:

SLT

SLT: A New Treatment for Glaucoma Becomes Available

An Update on the Use of SLT for Treating Glaucoma


SRT



Ellex 2RT

Ellex 2RT Retina Regeneration Therapy: A First Report