An Eye on Innovation!
TFOS Innovation Showcase
Thursday, September 8th, from 6:30 - 7:30 pm
All conference attendees are invited to join!
The below startups have been selected present at the TFOS i2 Innovation Showcase on Thursday, September 8th, in Montpellier, France.
Each startup will give a 3 minute presentation, followed by 3 minutes of questions.
David A. Sullivan, MS, PhD, FARVO
Senior Scientist, Schepens Eye Research Institute
Associate Professor, Department of Ophthalmology, Harvard Medical School
Head of Ophthalmology Business Development, Eye Care, Shire
Vice President, Neurostimulation, Allergan
Start-ups presenting at the TFOS Innovation Showcase:
Avizorex is a Venture Capital backed ophthalmology biotech founded in 2013 and headquartered in Barcelona, Spain. Avizorex is focused on developing novel therapies for Dry Eye Syndrome, based onthe research of Professor Carlos Belmonte at the Neurosciences Institute, in Alicante, Spain. Thisresearch group discovered the role of eye surface temperature-sensitive nerve fibers in tear filmregulation.
Avizorex lead product candidate is AVX-012, a First-in-Class small molecule with a new Mechanism of Action, based on the maintenance of a regular basal tear flow and blinking rate through theenhancement of nerve impulse activity of cold thermoreceptors through the selective activation ofTRPM8 ion channel.AVX-012, formulated as an ophthalmic solution, is entering a First-in-Human, Phase I/IIa Proof-of-Concept clinical study in Spain to confirm its safety, tolerability and efficacy in mild to moderateDry Eye Syndrome patients.
Chief Executive Officer/Founder
AVIZOREX PHARMA, S.L.
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Cambium has invented a novel way to process allogeneic (donor) vs. autologous (patient) platelets into an enriched platelet-rich-plasma (PRP) lysate biologic (Aurarix). Cambium's first application of this novel biologic will be Elate Ocular biologic eye drop for dry eye syndrome. Platelets are important reservoirs of key nutritive and regenerative components helping facilitate homeostasis, tissue regeneration, immune response and wound healing. Platelets contain over 30 known biologically active components such as growth factors, proteins, vitamins, lubricants ,anti-inflammatory agents, bacteriostats and electrolytes. These same components are found in healthy tear film where they help restore and maintain corneal homeostasis. Since 1983 in the U.S.autologous/PRP serum drops have been generally acknowledged in over 100 published articles as generally safe and effective for the temporary relief of dry eye symptoms. Additionally, serum dropshave been used for numerous additional corneal diseases and conditions such as corneal ulcers, persistent epithelial corneal defects, Sjogren's syndrome, graft-vs.-host disease, LASIK cornealerosions and others.
However cost (no reimbursement coverage in the U.S. due tonon-standardization), inconvenience and invasiveness of obtaining patient sourced serum, absence of industry standards/FDA guidelines, variability of serum components within patients, presence of certain "contaminants" such as trace systemic drugs from older diseased patients or fibrinogen (serum's clotting agent--counter-productive on the eye in a topical drop), short shelf life,freezer/refrigerator storage and finally risks of unintended bacterial contamination from non-preserved multi-use packaging--all have prevented serum drops from becoming a main stage therapy to date.
That is about to change with Cambium's Elate Ocular biologic eye drop for dry eye.
Elate Ocular will be a standardized, commercialized, GMP manufactured, FDA approved, allogeneic and not equivalent but an enriched version of today's serum drops. And unlike OTC or Rx dry eyedrops on the market or under development today, Elate Ocular will contain not one but over 30"active ingredients" targeting not one (e.g., inflammation) but multiple etiologies contributing to dry eye. A U.S. FDA Phase I/IIclinical trial for graft-vs.-host disease dry eye under orphan/fast trackreview is planned for latter 2016. A Phase I moderate/severe dry eye study is also planned in latter 2016/early 2017 in Taiwan via a strategic partner. Results from this second trial will be used insubsequent FDA, TFDA and CFDA submissions. A shelf stable formulation in novel single-use packaging is also contemplated for eventual commercialization. Finally, early investigations suggest Elate Ocular will obtain U.S. reimbursement coverage.
Terence A. (Terry) Walts
Cambium Medical Technologies
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EpiTech Mag, Israel
EpiTech LTD is ready to bring to the market a revolutionary treatment for Dry Eye Syndrome. Extensive studies in a rabbit dry eye model showed promising results in protecting the cornea from extreme desiccation conditions.
Dry eye syndrome affects 5-6% of the world population and as high as 34% of the elderly. It is expected that the number of cases will grow by 2.8% each year, from 196 million cases in 2012 to 250 million cases in 2022.
Many types of eye drops have been developed to lubricate dry eyes and help maintain moisture on the outer surface of the eye. However, their efficacy is limited; compliance rates are low, it may take months to relieve symptoms, and most of the products offer only short-term relief.
Recent devices have tried to improve either tear production or meibomian gland secretion. No current treatment directly targets the ocular surface disease.
Our non-invasive, non-contact solution presents a novel treatment for both aqueous-deficient and evaporative dry eye patients.
Using our proprietary magnetic stimulator device and treatment regimen, we apply to the cornea a sequence of time-varying magnetic field pulses that increase the durability of the corneal surface.
We have shown in a rabbit model that the magnetic treatment preserves the integrity of the corneal surface under extreme desiccation. Compared with untreated control eyes, treated eyes have shown a significant decrease in corneal fluorescein corneal staining following desiccation and significantly reduced fluorescein concentration in the anterior chamber. The therapeutic effect of a single, 10-minute session was maintained for at least 12 weeks. Enhanced tight junction contacts were demonstrated in treated eyes under desiccation conditions. Optical Coherence Tomography, electroretinogram, biomicroscopy and histopathology analysis revealed no pathological changes in treated eyes, clearly demonstrating the treatment’s safety. These studies suggest that the repetitive magnetic stimulation treatment developed by Epitech Mag presents a breakthrough in protecting the corneal surface in DES.
CEO & co-founder
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mu-Drop offers in collaboration with Sanquin BB - the Netherlands, technology to manufacture singleuse micro serum eye drops to others who are interested to manufacture serum eye drops efficientlyand safe. mu-Drop single use micro serum eye drops could contribute to a significant cost reduction to manufacture serum eye drops and better therapeutic outcome of dry eye syndrome treatment. mu-Drop developed a single use serum micro eye drop that are 10 smaller than currently available serum eye drops and are very efficient and safe to manufacture in a fully closed system. The benefit of the single use serum micro eye drop for the patient is that no donated serum is spilled and one donation allows for more than 2 years treatment. The mu-Drop single use serum micro eye drops are simple to use and very well tolerated. mu-Drop single use serum micro eye drops benefits are:
- Simple to use
- 10 times smaller than classic drops
- Comfortable and tolerable
- No spillage of donated serum
- 1 donation for up to 2-year treatment
- Less donations required
- Fully closed manufacturing technology
- Very efficient manufacturing
- Known technologies
- Short learning curve for technicians
Sanquin BB - the Netherlands, is preparing to supply mu-Drop single use serum micro eye drops in the Netherlands.
Chief Executive Officer
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Opia Technologies, France
Founded in January 2010 and based at the Vision Institute in Paris, OPIA Technologies is a company dedicated to the development of an innovative portfolio of medical devices for the diagnosis of ocular surface diseases.
Ocular surface components can be sampled with efficient and reliable sampling devices for the purposeof bio-molecular analysis.
OPIA is marketing EYEPRIM, a sterile device to perform nearly painless conjunctival sampling of the living eye, enabling further analysis of cells or biomarkers components. EYEPRIM greatly facilitates the conjunctival impression technique, thus making it available for allpractitioners. It is very appreciated for follow-up clinical studies thanks to its samplingre productibility, high yield and very little training requirements.OPIA is also developing TEARPRIM, a sterile medical device designed to sample the tear film. This new tear sampling device aims to replace the tedious, labor-intensive current sampling techniques.
TEARPRIM allows the automatic collection of high quantity of tears in a nearly painless andminimally-invasive way.
We have developed a mucoadhesive micelle designed for controlled drug delivery to the front of the eye. Briefly, we have synthesized a diblock copolymer (poly[L-lactide]-b-poly[methacrylic acid-co-3-acrylaminodophenylboronic acid]) which self assembles as a micelle presenting phenyboronic acid(PBA) on its shell. These nanoparticles are designed to adhere to muscin, thereby binding to themucus layer of the ocular surface and allowing prolonged, controlled release of drug. We wish to change the efficacy and frequency of traditional eye drops with our technology.
Heather Sheardon, PhD
Professor, Chemical engineering, McMaster University
Canada Research Chair, Ophthalmic Biomaterials & Drug Delivery Systems
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Signal Ophthalmic Consulting, US
Ocular Surface Disease affects more patients than any other eye disease. However, it is woefully under-diagnosed and often undertreated. Many practitioners do not know where to begin, what technology to invest in or how to incorporate dry eye care without sacrificing efficiency. The need for patient care is staggering and can only be tackled by physicians armed with the knowledge to provide appropriate care.
My team has developed a web-based educational platform designed to bring dry eye care into any practice. As an informational hub, the platform offers easily digestible information demonstrating clinical techniques, existing and emerging technology, research publications and meetingopportunities. Much of the educational information provided by the site will be in the form of short videos. The video content will feature diagnostic testing, examination techniques and treatment considerations. Depending on the practitioner's level of experience, he/she can select videos that bestserve his/her clinical needs.
While content will be weighted heavily towards clinical application, the platform will also feature practice management recommendations. One of the chief reasons that doctors do not treat ocularsurface disease more aggressively is because of their concern that it will hinder practice efficiency or not provide a good return on investment. It will offer suggestions for implementation in a "real world"setting. Staffing concerns, equipment vetting and diagnostic flow will be addressed.
This web-based platform will deliver unparalleled OSD education in a fashion that makes it accessible for foundational practitioners as well as the technically advanced. Ideally, it will reach eye care providers globally offering reliable education and innovative technology. Long-term goals include certified continuing continue education, web-based international roundtables and live social media events.
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Suricog is positioned as the French leader of the connected eye on two main axes.
The first one is for its EyeBrain products. These are medical devices using video-oculography, or eyetracking with the goal of analyzing the brain's functional structures and activity. It provides assistancein the diagnosis of neurological and psychiatric diseases. Based on oculomotricity (recordings ofocular movements), they provide early, objective and accurate markers of neurological diseases suchas Parkinson's syndrome, multiple sclerosis or Alzheimer's disease. By comparing the results obtained in an affected patient with the standards acquired in healthy subjects, EyeBrain Trackers are able toprovides the practitioner with an aid for early diagnosis. They are also tools that allow the analysis oftreatment effects or the monitoring of disease progression. At the same time, numerous clinical studies using an EyeBrain tracker are under way in major hospitals and research centers on a very great number of diseases.
Unlike the eye tracker dedicated to research, our system provides standardized oculo motor tests, which are analyzed automatically to provide healthcare professionals comparison.EyeBrain is based on videao-oculography to record both eyes in real-time. The acquisition of eyemovements controlled by a software which allows acquisition and analysis of several ocular parameters as well as an oculomotor review. This review is then compared to normative values inorder to guide the diagnosis.The second product developed by SuriCog is EyeDee. It provides embedded eye tracking hardware andsoftware solutions to address all features of human vision within the digital word. This mobile andreal time technology, integratable to any mount, offer unique possibilities for creating eye-environment interactions, behavioral analysis of the eye and the gaze, and for relating one's eye to the world ofconnected objects. Designed for natural usability, they add wellness and security to all visual processes, whether impaired or not, enabling endless opportunities of an 'augmented' control over the digital or real surrounding environment.
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Topical Lacripep TM is a breakthrough opportunity for all forms of dry eye that eliminates corneal staining and independently promotes basal tearing without irritation for hours by natural physiological processes. Lacripep TM is a synthetic peptide of lacritin, discovered by Gordon Laurie from an unbiased screen for novel factors capable of addressing dry eye. The biochemical characterization has led to a deep understanding of its mechanisms and specificity.
1. Lacritin is discovered as a novel basal tear regulatory factor present in normal human tears. Affects only basal, not reflex, tear protein release.
2. Lacritin dose response, receptor targeting and signaling mechanisms are established for human cells.
3. Lacritin's active domain is identified by truncation and point mutant analysis. The active domain is represented by Lacripep TM.
4. Lacritin is found to be the master protector of human tears. Normal tears immuno depleted oflacritin and tears from dry eye patients fail to restore INFG/TNF stressed and dying corneal epithelial cells. Dry eye tears spiked with lacritin or normal tears are restorative.
5. Inactivation of bioactive lacritin in dry eye is found to be due in part to cross-linking by tear tissue transglutaminase. Lacripep TM is completely resistant.
6. Topical lacritin is found to promote basal tearing in normal rabbits. Tearing from a single dose lasts for at least 4 hrs. Three times daily dosing for 2 wks promotes tearing and is well-tolerated. In dryeye mice, topical Lacripep TM (or lacritin) three times daily for 3 weeks: (i) eliminated cornealstaining, (ii) restored basal tearing, and (iii) reduced lacrimal gland inflammatory foci. New(unpublished) data reveals the mechanism.
7. Lacripep TM (19 amino acids long) is found to be equipotent to lacritin in relief of human corneal stress.
8. Manufacturing of cGMPLacripep TM is complete.
9. Experienced business team headed by CEO/President and Cofounder Mark Logan. Mark is the former Chairman and CEO of VISX, Inc (which invented, obtained FDA approval and commercialized the procedure for correcting refractive vision errors known as LASIK). He is former Senior VP, COO and member of the board of Directors of Bausch & Lomb, and is currently Chairman of the Board of STAAR Surgical Company, a publicly traded ophthalmic company.
10. TearSolutions recently closed its Series A fundraising at $3M.
CSO & Cofounder
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