Month: April 2014

The AOP and FODO have announced the formation of new joint committees and are inviting other optical partners to join in.

Following the calls for more joined up working at the FODO and AOP AGMs earlier in the year, the aim of the new committees will be to provide a clearer focus and more united voice especially for the commercial, manufacturing and retail parts of the eye health sector.

The new committees are:

– Policy and Strategy – chaired by Brian Carroll and Michael George
– Education – chaired by Ed Bickerstaffe and Glenn Tomison
– Primary Care – chaired by Kevin Thompson
– Communication & Public Affairs – chaired by Jayne Rawlinson
plus a new Working Group on information and IT (Chair to be announced).

The first meetings of most of the new committees will be held on 11 November.

Commenting on the announcement Michael Charlton, Chairman of the AOP, said: “FODO and the AOP already had similar and overlapping committees with cross memberships. The time is now right to streamline these arrangements and also to open them up to our optical partners more widely.”

Paul Carroll, Chairman of FODO said: “This is the first step of what we hope will be a productive process which will improve our effectiveness as a sector. With a united voice – standing and speaking together – we will have far more impact for our sector and our patients.”

Welcoming the announcement, ABDO President Barry Duncan said: “ABDO will be delighted to play its full part in these new arrangements. There is a new confidence within dispensing optics and we have seen what can be achieved by working closely with our partners through the new UK Vision Strategy and negotiations on the GOS contracts in all four UK countries.”

Andrew Actman Chairman of the FMO said: “From the manufacturing and import of equipment and product through to the testing of sight and the delivery of better eye health, we all play important roles in the patient journey. Working and speaking together on issues of mutual interest can only be good for the nation and for our members.”

Clive Sutton, Chairman of Association of Lens Manufacturers, said: “As we said following our AGM in October we too are delighted to join in these new arrangements. Often issues are raised by our members which directly concern members in other organisations and their patients and there was no ready forum in which to discuss them. Now we have that and, speaking with a united voice, ought to be able to ensure that the eye health sector really punches its weight for the first time.”

The College of Optometrists, which is the professional, scientific and examining body for optometry, will both have observer status on relevant committees. Dr Rob Hogan, President of the College said: “This is a welcome development. The College’s own experience of joint working through our membership and standards committee and working groups has been very positive. Collaborating more widely can only strengthen the sector and we look forward to playing our full part in the new arrangements”.

The BMA will also be involved, representing the OMPs. Professor Suryanarayanan Nagasubramanian said; “The BMA has jointly worked with the optical bodies on GOS fees for many years and we have also been closely involved in negotiating the new GOS contract. Ophthalmic medical practitioners, optometrists, dispensing opticians and other stakeholders can only benefit from a more collaborative approach and we look forward to our participation.”

Tony Garrett, David Hewlett and Bob Hughes, on behalf of the Chief Executives said: “We already keep in regular touch and often meet together as a group to plan collectively when that is appropriate. It is helpful that our committees and members will also now be working in a more joined up way so that we can make best use of the talent that there is in optics for the benefit of the people we all serve.”

In the wake of the announcement:

The AOP will abolish its Negotiation and Legislation Committee, and Education Committee, and its Public Affairs Committee will become the new Primary Care Committee . FODO will abolish its Negotiation and Europe Committee and its Education and Professional Standards Committees . the joint Domiciliary Eyecare Committee will continue as now with Thurka Sivapalan replacing Jayne Rawlinson as Chair. Jayne leaves after 5 successful years to become Chair of the new Communication & Public Affairs Committee and Chair of FODO next May.

Source
Laura Beaumont
vision2020uk

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today confirmed that its partner, R-Tech Ueno, Ltd. (“RTU”) (Osaka Securities Exchange Hercules code: 4573), reported the results of its recently completed phase 2 clinical trial of UF-021 in retinitis pigmentosa patients. The results showed improvement in visual function dose-dependently in both visual field test and subjective findings. Furthermore, although there was an irritation upon instillation, there were no severe adverse effects.

This was a multi-center, randomized, double blind, three parallel group, placebo controlled study conducted according to current Good Clinical Practice (cGCP). This phase 2 clinical study of UF-021 was conducted in 112 mid-stage to late-stage retinitis pigmentosa patients.

In April 2009, Sucampo licensed from RTU the development and commercialization rights to UF-021 for the United States and Canada, including all associated patents, improvements and other intellectual property owned, controlled and developed by RTU.

The data from this trial is undergoing further analysis and will be submitted to an appropriate scientific conference for presentation.

Retinitis pigmentosa is a genetic disease characterized by progressive, irreversible vision loss and decreasing visual acuity. As RP progresses, daily life becomes increasingly more difficult. Blindness from all causes is among the most significant injuries to a patient’s quality of life and is a major driver of patient-based cost of care and life-style maintenance. There are no drugs or therapeutic procedures currently approved for the treatment of RP today.

About R-Tech Ueno, Ltd.

R-Tech Ueno is a bio venture company established in September 1989 for the purpose of marketing and R&D of drugs. Under leadership of the CEO, also a medical doctor, the company is developing new drugs on the theme of “Physician-Oriented New Drug Innovation”, targeting ophthalmologic and dermatologic diseases that previously had no effective therapeutic agent. We aim at becoming a “global pharmaceutical company specializing in specific fields (ophthalmology and dermatology) and selling and developing pharmaceutical products through the eyes of doctors.” We are promoting development of new drugs for unmet medical needs (medical needs that are not fulfilled yet) which the Japanese government recommends and assists, orphan drugs and the drugs in the field of anti-aging (lifestyle drugs).

Source
Sucampo Pharmaceuticals, Inc.

Although it is already one of medicine’s most successful transplant procedures, doctors continue to seek ways to improve corneal transplants. A new report by German and British researchers shows that transplanted corneas are more likely to fail or be rejected in patients whose eyes exhibit abnormal vessel growth, called corneal neovascularization, before surgery. The team’s meta-analysis of recent studies appears in July Ophthalmology, the journal of the American Academy of Ophthalmology. Their findings also suggest a new treatment that could improve transplant success rates.

Claus Cursiefen, MD, and colleagues reviewed 19 studies involving nearly 24,500 corneal transplants (called “grafts”). The cornea is the eye’s clear outer surface that provides much of the visual power.

“The presence of corneal neovascularization before surgery makes it about 30 percent more likely that the transplant will fail, and more than doubles the risk of graft rejection,” said Dr. Cursiefen. “We also found that the risks of failure and rejection rise with the extent of vascularization – the more extensive it is, the higher the risks.”

This implies that patients who have corneal neovascularization might benefit from treatment before transplant surgery with growth-inhibiting drugs (antiangiogenics) such as bevacizumab or ranibizumab, or with another type of drug that works at the level of gene transcription to discourage vessel growth; one such drug, GS101, is now in clinical trials. This “preconditioning” approach is worthy of thorough testing and assessment, the researchers say.

“Preconditioning may prove to be a useful strategy to promote survival of the graft,” Dr. Cursiefen said.

More than 40,000 transplant surgeries are performed annually in the United States to restore vision in people whose corneas have been damaged by injury or illness-it is the most common type of tissue transplant. Patients with nonvascular corneas have a high chance of success: up to 81 percent of such transplants remain healthy at five-year follow up.

Ophthalmologists (Eye M.D.s) use several pre-surgery measures to enhance success rates, such as matching cornea donor and recipient tissues as closely as possible and suppressing the immune response in the person receiving the graft. After transplants doctors monitor patients closely for signs of failure and treat early and aggressively if warning signs appear.

Dr. Cursiefen’s review found that increasing age and male gender appear to be additional, independent risk factors for graft failure, but not for graft rejection; he says further study is needed to confirm these findings. In June 2009 (Ophthalmology) the Cornea Donor Study reported lower rates of corneal transplant success in patients who had corneal edema (swelling) after surgery for cataract removal and intraocular lens implantation, and in glaucoma patients.

Source:
American Academy of Ophthalmology

QLT Inc. (NASDAQ: QLTI; TSX:
QLT) announced that it has initiated a Phase I safety study in
healthy adults of QLT091001, an orally administered synthetic retinoid
replacement therapy for 11-cis-retinal, which is a key biochemical
component of the visual retinoid cycle. The drug is being developed for the
potential treatment of Leber’s Congenital Amourosis (LCA), an inherited
progressive retinal degenerative disease that leads to retinal dysfunction
and visual impairment beginning at birth.

The Phase I study is an open-label, single center, ascending dose trial
that will determine the safety and tolerance of multiple administrations of
the synthetic retinoid drug in approximately 18 healthy adult volunteers.
Participants will be enrolled in up to 6 cohorts of increasing doses.

“We believe our retinoid synthetic drug program is a very interesting
opportunity as there are no currently available treatments for patients
with LCA, which affects one in one-hundred thousand newborns world-wide,”
said Bob Butchofsky, President and Chief Executive Officer of QLT. “This
program also supports the Company’s new ocular focus and we look forward to
reporting the Phase I data in the first half of 2009. We hope that our
findings will support further clinical studies in this orphan indication.”

About Synthetic Retinoid Drugs

Genetic diseases in the eye such as Leber’s Congenital Amaurosis (LCA)
and Retinitis Pigmentosa (RP) arise from gene mutations of enzymes or
proteins required in the biochemistry of vision. QLT091001 is a replacement
for 11-cis-retinal which is an essential component of the
retinoid-rhodopsin cycle and visual function. Two different gene mutations
(Retinal pigment epithelium protein 65 (RPE65) and lecithin-retinol
acyltransferase (LRAT)) result in an inadequate production of
11-cis-retinal and occur in approximately 10% of patients with LCA and to a
lesser extent in RP.

The basis for using synthetic retinoids as replacement therapy for
conditions where genetic defects result in deficiency of 11-cis-retinal is
founded on experiments in mouse genetic models. These experiments used mice
that have mutations in either the RPE65 or LRAT genes, the same as those
associated with LCA in humans. Both mouse models have clinical features of
the human disease. The biological activity of the synthetic retinoid was
monitored by measuring the level of pigment-related compounds in the eye.
Retinal function was also assessed by detecting electroretinograms (ERGs),
electrical nerve signals from the retina. Oral administration of QLT091001
showed evidence of having corrected the biochemical defect in the retinoid
cycle in light-sensing cells (rods) and appeared to restore ERG responses
to light in both models of LCA.

About Leber’s Congenital Amaurosis

Leber Congenital Amaurosis (LCA) is an inherited degenerative retinal
disease characterized by abnormalities such as roving eye movements and
sensitivity to light, and manifesting in severe vision loss from birth. Eye
examinations of infants with LCA reveal normal appearing retinas. However,
low level of retinal activity, measured by electroretinography (ERG),
indicates very little visual function.

About QLT

QLT Inc. is a global biopharmaceutical company dedicated to the
discovery, development and commercialization of innovative therapies. Our
research and development efforts are focused on pharmaceutical products in
the fields of ophthalmology and dermatology. In addition, we utilize three
unique technology platforms, photodynamic therapy, Atrigel(R) and punctal
plugs with drugs, to create products such as Visudyne(R) and Eligard(R) and
future product opportunities. For more information, visit our web site at
qltinc.

In April of 2006, QLT entered into an exclusive worldwide
co-development and licensing agreement with Retinagenix, LLC, to develop
active synthetic retinoid products for the treatment of degenerative
retinal diseases. Pre-clinical studies have demonstrated that orally
administered synthetic retinoid drugs cause long-lasting restoration of
retinal function. Under the terms of the agreement, QLT is responsible to
develop and commercialize the products for use in ocular and all other
human diseases. Retinagenix has participated in research in support of the
co-development collaboration and is eligible to receive payments upon
achievement of certain development, approval and sales milestones as well
as a single digit royalty on net sales.

QLT Plug Delivery, Inc. is a wholly-owned subsidiary of QLT Inc.

Atrigel is a registered trademark of QLT USA, Inc.

Visudyne is a registered trademark of Novartis AG.

Eligard is a registered trademark of Sanofi-aventis.

QLT Inc. is listed on The NASDAQ Stock Market under the trading symbol
“QLTI” and on The Toronto Stock Exchange under the trading symbol “QLT.”

Certain statements contained in this press release, which are not
historical facts, are “forward-looking statements,” of QLT within the
meaning of the Private Securities Litigation Reform Act of 1995 and
constitute “forward-looking information” within the meaning of applicable
Canadian securities laws. Such statements include, but are not limited to:
our beliefs regarding the potential benefits, targets, market opportunity
and commercial success of our synthetic retinoid drug; our expectations
regarding our clinical development plans and strategy for the technology
and timelines associated with these; and statements which contain language
such as “expects,” “will”, “plans,” “estimates,” “intends,” “believes” and
similar expressions that do not relate to historical matters.
Forward-looking statements are predictions only which involve known and
unknown risks, uncertainties and other factors that may cause our actual
results to be materially different from the results expressed or implied by
such statements. Many such risks, uncertainties and other factors are taken
into account as part of our assumptions underlying these forward-looking
statements and include, among others, the following: risks and
uncertainties associated with the timing, expense and outcome of research
and development programs and commercialization of products (including the
difficulty of predicting the timing and outcome of the synthetic retinoid
drug development efforts, clinical testing and regulatory approvals or
actions); uncertainties regarding the impact of competitive products and
pricing; risks and uncertainties associated with the safety and
effectiveness of our technology; risks and uncertainties related to the
scope, validity, and enforceability of our intellectual property rights and
the impact of patents and other intellectual property of third parties; and
other factors as described in detail in QLT’s Annual Report on Form 10-K,
Quarterly Reports on Form 10-Q and other filings with the U.S. Securities
and Exchange Commission and Canadian securities regulatory authorities.
Forward-looking statements are based on the current expectations of QLT and
QLT does not assume any obligation to update such information to reflect
later events or developments except as required by law.

Batten ML, Imanishi Y, Tu DC, et al. Pharmacological and rAAV gene
therapy rescue of visual functions in a blind mouse model of Leber
congenital amaurosis. PLoS Medicine. 2005;2(11):1177-1189.

Van Hooser JP, Liang Y, Maeda T, et al. Recovery of visual functions in a
mouse model of Leber congenital amaurosis. J Biol Chem.
2002;277(21):19173-19182.

Van Hooser JP, Aleman TS, He Y-G, et al. Rapid restoration of visual
pigment and function with oral retinoid in a mouse model of childhood
blindness. Proc Natl Acad Sci USA. 2000;97(15):8623-8628.

Travis GH, Golczak M, Moise AR, and Palczewski K. Diseases caused by
defects in the Visual Cycle: Retinoids as Potential Therapeutic Agents.
Annu. Rev. Pharmocol. Toxicol. 2007;47: 469-512

QLT Inc.
qltinc

View drug information on Photodynamic Therapy.

Becoming the market leader in the neurostimulation sector, by initially helping blind patients regain their sight, is the
vision of Bonn-based start-up company IIP-Technologies.

IIP has made considerable progress in developing the first ‘intelligent’ retina implant in the world. Thanks to this implant
it is possible to restore limited eyesight to people who have lost their sight following retina degeneration.

In Germany alone, about 60,000 people suffer from retinitis pigmentosa, a hereditary visual defect that can lead to complete
blindness. Currently, there are no therapies available to treat the condition.

The patent-protected implant developed by IIP combines medicinal and information technology with micro-systems technology. A
blind patient has a unique microchip implanted in their eye, wears special glasses with an integrated camera and carries a
microcomputer on a belt around their waist. Visual information received by the glasses is converted into electrical pulses by
the microcomputer and the pulses then used to stimulate the patient’s optic nerve. The implant helps restore limited eyesight
to people affected with specific hereditary blindness.

IIP obtained encouraging results for their retina implant during an initial clinical research study conducted at four leading
university hospitals in Germany and Austria in 2003 and 2004. Of the 20 patients suffering from retinitis pigmentosa who
participated in the study, 19 reported that their visual perception had been triggered thanks to electrical stimulations from
IIP’s retina implant.

Following the promising results of their first clinical trial, IIP has launched a new trial this year, in cooperation with
University Hospital Hamburg, involving patients with macular degeneration. Additionally, IIP has initiated procedures to
obtain approval for their technology from the US Food and Drug Administration.

IIP was co-founded in 2002 by Steffen Suchert, the firm’s chairman, and now employs around 30 people. In March last year, IIP
successfully concluded a 4.5m euro initial financing round involving PolyTechnos Venture-Partners Funds and Valtronic, a
Swiss electronics manufacturer.

“IIP plan to raise up to 10m euro in venture capital funding in the fourth quarter of 2005,” announce IIP management. “These
funds will be mainly used to finance the clinical trials necessary for the CE Mark and FDA approval processes, to produce the
devices necessary for those clinical trials, to continue with research and development and for marketing in connection with
the product launch.”

Looking to the next five years, IIP management announce: “Our intention is to have improved versions of the first product
(retina implant) on the market and a platform for new applications in the area of neurostimulation.”

IIP-Technologies GmbH
Niebuhrstra???e 1a
D-53113 Bonn
Germany
Tel: +49-228-969550
Fax: +49-228-9695522
Email: infoiip-tec.de
www.iip-tec

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SOURCE: alphagalileo

TargeGen, Inc. today announced that
the Company has initiated a multi-center Phase II clinical trial of
topically applied TG100801 in patients with age-related macular
degeneration (AMD).

AMD is the leading cause of blindness in adults with more than 3.5
million estimated patients worldwide. Currently approved treatments for
macular degeneration require repeated injection into the eye and act
primarily by reducing VEGF mediated retinal leakage. TG100801 is
administered non-invasively as an eye drop and is designed to suppress VEGF
mediated leakage and additional kinase targets associated with
inflammation, edema, and angiogenesis which are the pathological hallmarks
of AMD and other back of the eye diseases including diabetic macular edema
and proliferative diabetic retinopathy.

“The initiation of this trial is a significant milestone for TargeGen,”
stated Peter G. Ulrich, President, CEO and Co-Founder of TargeGen.
“TG100801 is an important drug candidate that potentially addresses the
leading causes of debilitating vision loss in adults in a more
comprehensive way and may eliminate or reduce the requirement for repeated
injections into the eye.”

In addition to TG100801, TargeGen is developing TG101348, an oral Jak2
inhibitor for the potential treatment of myeloproliferative diseases and
TG100115, a PI3K inhibitor for the potential treatment of certain
inflammatory disorders. A second topically applied compound for eye
disease, TG100948, is in early development.

About TargeGen, Inc.

TargeGen, Inc. is a privately held vascular biology-focused
biopharmaceutical company based in San Diego, CA. TargeGen primarily
develops small molecule kinase inhibitors that target vascular leakage
(edema), vascular proliferation (angiogenesis) and inflammation. Edema,
angiogenesis and inflammation are involved in the pathology of many major
human diseases.

TargeGen initiated operations in 2002 and has raised capital from top
tier venture capital sources. Current investors include VantagePoint
Venture Partners, Forward Ventures, Enterprise Partners, Chicago Growth
Partners, BB BIOTECH, Innovis Investments, H&Q Capital Management, Pappa s
Ventures and other investors.

TargeGen, Inc.
targegen

“Ver es Poder” – Seeing is Empowerment – is the theme for a Latino Glaucoma Awareness Day and Screening to be held Saturday, May 10, 9 am to 5 pm at the Delhi Center, 505 East Central Avenue, Santa Ana, presented by the Glaucoma Research Foundation (GRF) announced GRF President and CEO Thomas M. Brunner today at the formation meeting of the initiative’s Leadership Group. Jose Molina, Spanish-language broadcasting pioneer in the Southwestern states and chair of the Leadership Group, convened the formation meeting at the Irvine headquarters of the project sponsor, Allergan.

“The community partnership that makes this pilot project possible is comprehensive and inspiring,” reported Brunner, “especially with the ongoing support from Allergan, the leadership of Members of the California Latino Legislative Caucus, the expert guidance of Rohit Varma, MD and his colleagues in the definitive Los Angeles Latino Eye Study (LALES) from USC’s Doheny Eye Institute, the City of Santa Ana and Mayor Miguel Pulido, the Delhi Center, and of course the many members of our Leadership Council.”

“We are all committed to raising our communities’ awareness of this silent thief of sight, and to providing a variety of ways for our families, friends and neighbors at risk for glaucoma to protect their vision,” Molina said. The centerpiece of the formation meeting was a summary presentation by Dr. Varma on the LALES findings: that Latinos are among the highest groups at risk for glaucoma, and that as many as 75% of those with glaucoma are unaware of their condition.

A disease that in many cases has no symptoms at its onset, glaucoma can bring irreparable damage to the optic nerve, potentially leading to blindness. However, vision can be preserved with early detection and treatment. Also participating with Dr. Varma was his associate on the study, Carlos Lastra Gonzalez, MD, and the Project Manager, Mina Torres.

The plan for the Awareness and Screening Day itself is to offer free screenings for glaucoma and diabetic retinopathy from 9 am to 5 pm. Spanish-speaking physicians will be available to talk about any potential findings in the screenings, and information booths will be set up and staffed, ready with referrals on health access and resources. Everyone, from youngsters to seniors, is urged to attend.

The Day begins with a Kick-Off led by Mayor Pulido, members of the Latino Caucus, and members of the Leadership Council – including the famed “voice” of Ver es Poder, Fernando Escandon, who will also be passing out free copies of his CD reading the poem El Brindis del Bohemios. “At noon,” beamed Molina, “we are delighted we can showcase the wonderful new singing talent, 14-year old Jessica Flores. Everyone in the family will be captivated by her performance!”

Members of the Leadership Council, in formation, include: Senator Gil Cedillo, Vice Chair of the Latino Caucus; Senator Lou Correa; Robert Drabkin, noted philanthropist committed to advancing vision research; Fernando Escandon; legendary radio producer and advertising pioneer Teddy Fregoso; Scott Garmon of The Scott Garmon Company; Assemblyman Jose Solorio; Sergio Velazquez, Publisher of Miniondas and Ferandula, and additional representatives of the Latino Eye Study, Allergan, Santa Ana and the Delhi Center.

About The Glaucoma Research Foundation

Glaucoma Research Foundation, founded in 1978 and based in San Francisco, is the nation’s most experienced foundation dedicated solely to glaucoma research and education. Research programs include its precedent-setting Catalyst For a Cure consortia bringing together neuroscience and genetics laboratories from Johns Hopkins University, University of Utah, University of Washington, and Vanderbilt, to work in real time collaboration to speed the pace of discovery for a cure.

Education and outreach programs, besides the Latino Glaucoma Awareness Day, include the website glaucoma, the number one internet search choice for “glaucoma” and a national model of internet accessibility for the vision impaired, publications like Como Entender y vivir Con Glaucoma (also funded by Allergan), and its newsletter Gleams distributed at no cost three times yearly to more than 60,000 households nationally. For information on GRF, visit the website.

The Glaucoma Research Foundation

First Minister Rhodri Morgan has visited an important service that is leading the way in Europe in the eyecare of people with diabetes.

The Diabetic Retinopathy Screening Service, based in Treforest, is a successful part of the Welsh Assembly Government’s Eye Care Initiative, and provides a Wales-wide screening service that detects retinopathy in people with diabetes at an early stage. People with diabetes are at risk of developing this disease, which affects the blood vessels supplying the retina, and if left undetected could lead to blindness.

Since its establishment and roll out in the last five years, people with diabetes have been invited to attend a special screening at locations across Wales, where digital images of the patient’s eye are taken. The images are then sent to the Screening Centre in Upper Boat to be assessed. Patients are sent the results and can be referred to GPs and optometrists if necessary and even to hospital if there is urgency.

First Minister Rhodri Morgan said: “This service is invaluable to people with diabetes, who can be at risk of losing their sight if this disease goes undetected. By offering this service, there is a much improved chance of preserving people’s sight through the early detection of eye disease.

“What has impressed me on my visit today is that this service is way ahead of what is provided in other parts of the UK and even in Europe. The only other European country which offers a similar service is Iceland so this is yet another example of how Wales is setting the pace once again.”

Notes

The Wales Eye Care Initiative sets out to preserve sight through the early detection of eye disease and to help those with Low Vision whose sight will not improve. Details can be found at eyecarewales.nhs

The First Minister will visit the Diabetic Retinopathy Screening Service at 13.30 on Friday 12 September. The Diabetic Retinopathy Screening Service is based at 1 Fairway Court, Upper Boat, Treforest CF37 5UA

Wales Eye Care Initiative

Lux Biosciences, Inc., a privately held biotechnology company specialized in the field of ophthalmic diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LX201, a silicone matrix ocular (episcleral) implant that steadily releases therapeutic doses of cyclosporine A locally to the eye to prevent corneal transplant rejection. LX201 is currently being tested in the one-year pivotal LUCIDA clinical trial program, comprising two controlled studies investigating the use of LX201 in patients at elevated immune-mediated risk of rejection or graft loss subsequent to cornea transplantation.

“With this Fast Track designation, we can more rapidly work to provide a much needed therapy to patients,” commented Ulrich Grau, PhD, president and chief executive officer of Lux. “If successful, LX201 would become the first treatment available for the prevention of corneal transplant rejection.”

The fast track drug development program is designed to promote the development of drugs to treat life-threatening or very serious conditions and requires that the drug demonstrate the potential to address unmet medical needs. Sponsors of products in fast track drug development programs may be considered for one or more of the following procedures regarding marketing applications:

– Priority review of NDAs and BLAs
– Submitting of portions of an application, and
– Accelerated Approval

About LX201

LX201 is a silicone matrix ocular implant that steadily releases therapeutic doses of cyclosporine A locally to the eye for one year. Cyclosporine A is used widely as systemic therapy for the prevention of rejection following kidney and other solid organ transplantation. LX201 is implanted under the eyelid into the episcleral space (the area beneath the transparent tissue covering the white of the eye) in a minimally invasive procedure. Lux Biosciences is evaluating clinically the implant for the prevention of rejection in corneal transplantation. LX201 has received Orphan Drug status in both the United States and Europe.

About Lux Biosciences

Lux Biosciences, Inc. is a privately held biotechnology company focused on ophthalmic diseases. The company has a staged product portfolio of potentially first-in-class therapies distinguished by their short-term path to commercialization and potential to generate high revenue growth. The portfolio includes:

– Two Phase III clinical-stage projects including: i) LX211, the oral formulation of a next-generation calcineurin inhibitor developed as steroid sparing therapy for the treatment of non-infectious uveitis, and ii) LX201, a silicone matrix ocular (episcleral) implant that steadily releases therapeutic doses of cyclosporine A locally to the eye for the prevention of rejection cornea transplant recipients. Both the LUMINATE pivotal clinical program for LX211 for the treatment of uveitis, as well as the LUCIDA pivotal clinical program with LX201 for the prevention of corneal transplant rejection were initiated in early 2007 and include sites in North America and Europe.

– LX214, a novel topical eye drop formulation currently in IND-enabling studies with a target date for entry into the clinic in mid 2008. LX214 is based on Lux’s proprietary next-generation calcineurin inhibitor and is targeted towards other chronic inflammatory diseases of the eye, most notably dry eye syndrome, blepharitis and atopic keratoconjunctivitis.

– Several earlier stage projects based on proprietary product-enabling bio-erodible polymer technologies that facilitate targeted and sustained delivery of molecules to the eye.

For more information on Lux Biosciences, please visit the company’s website at luxbio.

Two major eye diseases and leading causes of blindness age-related macular degeneration and diabetic retinopathy can be reversed or even prevented by drugs that activate a protein found in blood vessel cells, researchers at the University of Utah School of Medicine and several other institutions have announced in a new study.

Damage from both diseases was prevented and even reversed when the protein, Robo4, was activated in mice models that simulate age-related macular degeneration (AMD) and diabetic retinopathy, according to Dean Y. Li, M.D., Ph.D., senior author of the study published March 16 in Nature Medicine online.

Robo4 treated and prevented the diseases by inhibiting abnormal blood vessel growth and by stabilizing blood vessels to prevent leakage. Abnormal blood vessel growth and leakage are two primary factors in both age-related macular degeneration (AMD) and diabetic retinopathy. But the study’s ramifications go beyond eye diseases.

Serious infections such as SARS (Severe Acute Respiratory Syndrome), for example, kill people when an infection destabilizes blood vessels, allowing fluids to leak into the lungs. Tumors hijack blood vessel growth to feed on nutrients and grow. Although this study did not prove Robo4 would treat those diseases, Li believes it merits investigation.

“Many diseases are caused by injury or inflammation destabilizing blood vessels and causing them to leak fluid into adjacent tissues as well,” said Li, professor of internal medicine and an investigator with the University’s Program in Human Molecular Biology and Genetics. “We found a natural pathway the Robo4 pathway that counterattacks this by stabilizing blood vessels.”

“This discovery has significant implications for developing drugs that activate Robo4 to treat AMD and diabetic retinopathy,” said Kang Zhang, M.D., Ph.D., associate professor of ophthalmology and visual sciences at the University of Utah’s John A. Moran Eye Center and an investigator with the University’s Program in Human Molecular Biology and Genetics. Li and Zhang’s laboratories closely collaborated on the research, using the same animal models of AMD and diabetic retinopathy that are required for drug development. The collaboration means the time required to test the approach in people could be shortened, perhaps by years. Nonetheless, both Zhang and Li caution that getting new drugs to market still would take a number of years.

Randall J. Olson, M.D., director of the University’s John A. Moran Eye Center and professor and chair of ophthalmology and visual sciences, called Li’s finding historic.

“This is a major breakthrough in an area where the advances have been minimal,” Olson said. “We are excited about taking this opening and moving the frontier forward with real hope for patients who have but few, often disappointing, options.”

The discovery is a prime example of basic science research yielding a discovery with direct clinical applications, according to Hemin Chin, Ph.D., director of ocular genetics program at the National Eye Institute. “Given that vascular eye diseases, such as age related macular degeneration and diabetic retinopathy, are the number one cause of vision loss in the United States, the identification of new signaling pathways that prevent abnormal vessel growth and leakage in the eye represents a major scientific advancement,” said Chin.

Blood vessel growth (angiogenesis) is critical in human development and as a response to injury or disease. In earlier research, Li had shown that a family of proteins, netrins, induce blood vessel and nerve growth in mice, a discovery with important ramifications for potential therapies to help people with too few blood vessels. But when the body grows new blood vessels at the wrong time or place, these blood vessels are often unstable and weak, which causes them to leak and potentially lead to diseases such as macular degeneration and diabetic retinopathy.

In 2003, Li’s laboratory cloned Robo4 and showed it served the opposite function of netrins by inhibiting blood vessel growth and the destabilization that causes leakage. Robo4 is found only in cells in the interior surface of blood vessels and is activated by a protein called Slit. After being activated, Robo4 initiates a chain of biochemical events to stabilize blood vessels and prevent uncontrolled growth.

“Everything in biology has a yin (negative) and a yang (positive), and in the previous paper on netrins we brought attention to a new signaling pathway that induces vessels and nerves to grow,” Li said. “Robo4 is the yin to that process, preventing new vessel growth by stabilizing the integrity of mature blood vessels.”

Age-related macular degeneration is the most common cause of legal blindness in people age 65 or older and is expected to become an increasingly common and costly health issue as the number of older people in United States increases. Diabetic retinopathy is the most common cause of legal blindness in working-age Americans. Currently, there are an estimated 21 million people with diabetes.

Li’s collaborators on the study from the University of Utah include co-first authors graduate student Christopher A. Jones and Nyall London, an M.D./Ph.D. candidate in the Department of Oncological Sciences and the Program in Human Molecular Biology and Genetics. Several other researchers from Li’s lab also contributed to the project. In addition, researchers from the University of California, San Diego, the National Heart, Lung, and Blood Institute, and Harvard Medical School were part of the study.

The study was funded largely by the National Heart, Lung, and Blood Institute and the National Eye Institute, both are part of the National Institutes of Health.

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