OIS XIV PRESENTING COMPANIES
Carlos Quezada-Ruiz, MD, FASRS, Senior Vice President, Clinical Research and Development, and Therapeutic Area Head, Ophthalmology - 4DMT
4DMT is a clinical-stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine to treat large market diseases. We use our transformative vector discovery platform, termed Therapeutic Vector Evolution, to create customized and proprietary gene delivery vehicles (i.e., vectors) to deliver therapeutic payloads to specific tissue types associated with the underlying disease via the optimal route of administration. Our product design, development and manufacturing engine empowers us to efficiently create our valuable and diverse product pipeline. This combination of bold innovation and relentless execution gives 4DMT the capability to revolutionize genetic medicines and to strive for potential curative therapies.
Laurent Fischer, MD, President & CEO - Adverum Biotechnologies
Adverum is pioneering the use of gene therapy as a new standard of care for highly prevalent ocular diseases. Adverum’s lead program, Ixoberogene soroparvovec (Ixo-vec), is designed to be administered as a one-time IVT injection in the physician’s office, deliver long-term efficacy, reduce the burden of frequent anti-VEGF injections, optimize patient compliance, and improve vision outcomes for patients with wet AMD.
Adam Griese, Director - AesculaTech
AesculaTech is a technology startup cultivating a new class of materials that respond to environmental stimuli for use in medical and consumer products. The company is working towards FDA clearance of a medical device that treats dry eye disease using the world's smallest, single-use, prefilled autoinjector and a never-before-marketed, smart hydrogel.
Diane Tang-Liu, PhD, FAAPS, FCP, President & CEO - AiViva BioPharma
AiViva is a clinical stage biotech company founded in 2015 by four pharmaceutical industry veterans with more than 160 years of combined industry experience. AiViva's founders have demonstrated a successful track record across the full spectrum of drug development and commercialization, in addition to successful fundraises and IPOs on the NYSE and NASDAQ.
AiViva was formed with the mission of developing novel, innovative pharmaceutical products through an efficient, risk-mitigated development strategy to address major unmet medical needs.
We are developing drug products with the potential to transform treatment paradigms or significantly reduce the treatment burden for patients and physicians. Our approach leverages our proprietary JEL™ Technology to prolong the therapeutic effects of drugs and enhance their benefit-risk profiles. AiViva has a diverse pipeline of multiple novel drug candidates in development areas of dermatology, ophthalmology, oncology, and urology with the potential to expand to other areas of interest.
Dan Rosan, Chief Business & Financial Officer - Ascidian Therapeutics
Ascidian’s first-of-its kind RNA exon editing platform is designed to expand the therapeutic possibilities of RNA medicine and treat diseases not addressed by today’s gene editing technologies. By rewriting RNA, Ascidian’s exon editing technology provides the durability of gene therapy without the risks of direct DNA editing or gene replacement, while maintaining endogenous gene expression patterns and levels. Disease-causing genetic mutations are often located at different sites on the gene in different patients. Ascidian’s technological platform can replace multiple contiguous exons — not just single bases — providing a more powerful and versatile RNA therapeutic approach. Ascidian is a 2024 Fierce 15 winner.
Jill Hopkins, MD, Chief Medical Officer & President of Research & Development - Aura
At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies.
Greg Kunst, CEO - Aurion Biotech
Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. It received the prestigious Prix Galien award for best start-up in biotech. Its first candidate, AURN001, is for the treatment of corneal edema secondary to corneal endothelial disease, and the first clinically validated cell therapy for corneal care, having received regulatory approval in Japan. The Company has completed enrollment for its Phase 1/2 clinical trial in the U.S. and Canada. Privately held, Aurion Biotech is backed by Deerfield, Alcon, Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary Ventures.
Rushi D. Trivedi, Senior Executive - BioJiva
BioJiva is a clinical stage company with an oral once daily therapy for Dry AMD with Geographic Atrophy. Our technology is based on deuterated fatty acids which prevent ferroptosis and work upstream of complement inhibitors like Izervay and Syfovre
Tom Williamson, Chief Commercial Officer - BioTissue
BioTissue is the proven industry leader for regenerative therapies in ophthalmology. BioTissue manufactures the only cryopreserved amniotic membrane, Prokera®, and AmnioGraft®, that is FDA designated for anti-inflammation, anti-scarring, and anti-angiogenesis. BioTissue also manufacturers AmnioGuard®, which is derived from umbilical cord and is commonly used by oculoplastic and glaucoma surgeons to provide strong tectonic support for treating corneal, scleral, socket, fornix, and eyelid problems. BioTissue has recently launched CAM360 AmnioGraft targeted for mild to moderate Dry Eye Disease and stage 1 Neurotrophic Keratitis. It is a ring-less cryopreserved amniotic membrane that is shelf stable and 12mm in diameter.
Nathan Fisher, Director of Medical Affairs - Clearside Biomedical
Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®). Clearside’s SCS injection platform, utilizing the Company’s proprietary SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector. The Company’s lead program, CLS-AX (axitinib injectable suspension), for the treatment of neovascular age-related macular degeneration (wet AMD), is in Phase 2 clinical testing. Clearside developed and gained approval for its first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which is available in the U.S. through a commercial partner. Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations.
Jeffrey Goldberg, MD, PhD, Co-founder & Director of the Board of Managers - Emmecell
Emmetrope Ophthalmics LLC, (aka “Emmecell”) is a privately-held biotechnology company developing cell-based therapies for the treatment of eye diseases. Emmecell’s platform technology leverages magnetic nanoparticles to effectively localize and integrate cell therapies to the appropriate target tissue. Emmecell’s lead product EO2002 is a treatment for corneal edema, the most common indication for corneal transplantation. Emmecell’s Magnetic Cell Delivery™ addresses the limitations of the current surgical options for corneal edema with a safe, effective, non-surgical approach. Emmecell’s intellectual property covers not just corneal edema, but also other ophthalmic indications such as geographic atrophy and glaucoma.
Moshe Weinstein, Executive Chair & CEO - Everads Therapy
Everads is an emerging startup with novel delivery technology to treat retinal diseases via suprachoroidal administration and is developing an early-stage pipeline that leverages our technology.
Our technology enables delivery of therapy to the choroid and retina via the suprachoroidal space (SCS), an emerging route of administration in ophthalmology due it its potential to increase drug efficacy and durability, thereby lowering patient burden. The potential benefits of SCS delivery are driving many pharmaceutical companies to explore this route, however, there are very few delivery technologies.
Everads’ technology offers an easy and safe injection of therapy to the back of the eye, overcoming some of the limitations of other SCS technologies with regards to particle size, volume, invasiveness and safety. Our technology has been validated in over 60 non-human-primates using various modalities including AAV vectors, anti-VEGF antibodies, nanoparticles, and other materials.
Everads was founded in 2017 within the RAD Biomed Accelerator in Tel Aviv. Its underlying technologies have been licensed from the Sheba Medical Center at Tel Hashomer.
Jay Cormier, Founder & CEO - Eyedaptic
Eyedaptic, is a software technology company addressing the large unmet need in the eye care field of AMD (Age Related Macular Degeneration) and other Diseases of the Retina. Our visually assistive solutions use Augmented Reality (AR) smart glasses, which contains Eyedaptic’s embedded proprietary simulated natural vision software as well as Multimodal Generative AI. This enables Eyedaptic to be adaptive to the user’s vision limitation, as well as their habits and environment, thereby giving them the Freedom to Live their Life!
Prasad Sunkara, President & CEO - Eyegenex
Eyegenex,Inc is a US based biotech company focusing on the development of gene and peptide therapies for Glaucoma and diabetic retinopathy. Glaucoma is a progressive eye disease that do not have a treatment except for prevention by lowering intra ocular pressure (IOP) that causes apoptosis of retinal ganglion cells resulting in glaucoma. The incidence of glaucoma in US is around 3 Million and 80 Million worldwide.
Eyegenex’s gene therapy product will be initially evaluated for the treatment of patients with normal tension glaucoma (NTG) that are refractive to IOP lowering drugs and surgery. About 400,000 patients in US and 12 Million around the world (with high incidence in Asia in particular Japan, China and India) suffer from NTG. The company has licensed patents from University of Colorado based on extensive animal work conducted by Prof. Ram Nagaraj. His extensive studies over a period of 10 years have resulted in significant prevention of retinal ganglion cell apoptosis as a result of inducing increased IOP in animal models.
Our recent data suggests after one year post IOP increase and treatment, a near complete protection of vision after a single intravitreal injection of gene therapy was observed. While the vehicle control animals were all most blind. These data strongly suggest the potential of this therapy for the treatment of glaucoma patients. Our recent studies in Non-human primates suggest a significant expression of the protein in retinal ganglion cells of the monkey eyes after intravitreal injection of the gene therapy product indicating the potential of the product for the treatment of glaucoma in humans. We are also developing a second product, a peptide therapy for the treatment of Acute angle glaucoma (AAG), a disease that needs immediate intervention by surgery or IOP lowering agents reduce the eye pressure. The incidence of this disease is about 200,000 in US and >3 Million worldwide. The peptide would be administered by intravitreal injection after lowering the eye pressure to prevent any further damage to the retinal ganglion cells and optic nerve that could lead to glaucoma.
Currently, Eyegenex is evaluating the gene therapy and peptide products in an African green monkey model of glaucoma. Based on successful completion, the company plans to file for an IND. After IND approval the company will conduct phase 1 and phase2 studies. We believe a positive phase 1 outcome should result in a strategic investment followed by an exit.
Henrik Nagel, CEO - EYE-GO A/S
EYE-GO is a Danish MedTech company that aims to improve the quality of life for people dependent on eye medication by offering a high-precision micro-dosing ocular delivery system mitigating the imperfections with current eye drop bottles: MistGo®.
The way people take eye drops has hardly changed in the last century. Eyedropper bottles are difficult to use and overmedicate the eye simply due to the drop size. MistGo® is an innovative alternative to the conventional eye drop bottle, designed to help patients administer their eye medication in a more precise and user-friendly way – in any head position. A better user experience translates into higher patient compliance, healthier eyes, and higher quality of life for patients.
Kenchiro Kuninobu, PhD, Co-founder & CEO - FELIQS
FELIQS is a cross-border clinical-stage company focused on retinal diseases. We adopted a de-risk approach to obtain clinical POC based on our proprietary discovery platform, existing clinical evidence, and the extensive engagement of experienced industry experts.
Our two programs are as follows:
Age-related macular degeneration (AMD): FLQ-104, a proprietary innovative ferroptosis inhibitor for earlier intervention to treat Intermediate Dry AMD, targeting FIH in 2025, is currently under IND-enabling studies.
Retinopathy of prematurity (ROP): FLQ-101, a disease-modifying metabolic modulator/lipid peroxidation inhibitor, is ready to enroll patients in its US Phase 1b/2a study. The FDA has granted FELIQS orphan drug designation, resulting in 7-year exclusivity and fast-tracking the program to a commercial launch currently planned for 2027. FLQ-101 could represent a first-in-class oral treatment for ROP, which reduces neonatal hospital stay by 50%, hence addressing approximately a $1.0 billion market potential.
We secured lead investors and are currently raising an additional $10M to complete Series A. We are actively looking for investors to participate in this round.
Veysel Ozkapici, CEO & Co-founder - GlaucoT
GlaucoT digital platform offers a unique innovation, providing ground-breaking advantages with the potential to revolutionize glaucoma management. GlaucoT platform for gamma waves entrainment is comprised of the treatment device and the connected mobile application for the comprehensive digital home-based treatment. Multiple studies demonstrated that neuroprotection by sensory stimuli provides significant neuroprotection . We take advantage of an emerging gamma wave entrainment therapy that has demonstrated positive results in Alzheimer’s Disease (AD) patients and in aging mice retina. AD and glaucoma share common pathogenic neurodegenerative pathways in the eye and the brain; and aging is also a risk factor for glaucoma. Our device, GlaucoT, applies the flickering light for visual stimulation to provide neuroprotection in the retina and other tissues of the visual pathway. Therefore, the progression to a later stage of glaucoma and blindness could be delayed or completely prevented. Additionally, our mobile application tracks the drug use by the patients and reminds them when to take them, which will increase the compliance to the existing treatment methods. And our wearable device will be providing a novel method for intraocular pressure (IOP) measurement, enabling monitoring diurnal IOP data. This will lead to enhanced personalized treatment features such as getting the neuroprotective GlaucoT treatment & IOP treatment exactly at the time patients need it the most. In conclusion, GlaucoT platform aims to provide solutions for all needs of glaucoma patients including: i) Novel neuroprotective treatment ii) monitoring intraocular pressure iii) reminding the IOP drug use.
Jean-Pierre Hubschman, MD, Founder & CEO - Horizon Surgical Systems
At Horizon, we are revolutionizing microsurgery through advancements in robotics, medical imaging, and artificial intelligence. Our mission is to enable surgeons to extend beyond the limits of human precision.
Bos Gilles, Co-Founder & Investor - Kejako
Kejako, is a french MedTech company developing a personalized, non-invasive, laser treatment which reverses the cause of presbyopia for midlifers.
Eric Daniels, MD, Chief Development Officer - Kiora Pharmaceuticals
Kiora Pharmaceuticals is a clinical-stage biotechnology company developing and commercializing products for the treatment of orphan retinal diseases. KIO-301 is being developed for the treatment of retinitis pigmentosa, choroideremia, and Stargardt disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration.
KIO-104 is being developed for the treatment of conditions associated with retinal inflammation and is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase.
Marc Odrich, MD, Chief Medical Officer - Lenz Therapeutics
LENZ Therapeutics is a late-stage clinical company developing innovative ophthalmic pharmaceutical products that improve vision, proudly based in San Diego. Our lead program is an aceclidine based eye drop designed to restore the loss of near vision associated with presbyopia.
Alan Hibbitts, PhD, CEO & Founder - LEP Biomedical Ltd
Founded in 2023, LEP Biomedical has developed "HyaGuard™", an easy to use, biodegradable, proprietary companion product to glaucoma drainage surgeries. Through its unique drug release technology, HyaGuard™ offers a solution to the uncontrolled inflammation and scar tissue formation that currently drives failure rates as high as 40% in year 1 post-surgery in moderate-severe glaucoma surgeries.
Initial pre-clinical studies in post-trabeculectomy rabbits found that use of HyaGuard™ resulted in significantly better tolerability and safety scores compared to traditional MMC+drops post-op care. In parallel, use of HyaGuard™ did not require co-application of MMC to maintain statistically significant >20% decreases in starting IOP up to the 4-week study end point.
LEP Biomedical have now completed a pre-seed raise of €110,000 ($120,000) for a 12-month runway in which to close a €4 million seed raise. Seed round objectives include GMP manufacture, full GLP pre-clinical validation and clinical trials application filing.
Edward R Truitt. III, CEO - Lubris BioPharma
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Lubris BioPharma is a clinical stage biotech developing recombinant human lubricin (rhPRG4) for the treatment of ocular surface disease including oGvHD, Sjogren's Syndrome & Dry Eye.
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Clark E. Tedford, PhD, President & CEO - LumiThera
LumiThera, Inc. is a medical device company commercializing a multi-wavelength instrument for the ophthalmologist’s office that improves vision and slows the progression of vision loss in patients with degenerative eye disease. The Company’s focus to date has been on the treatment of patients with dry agerelated macular degeneration (AMD). The Company has significant expertise in the use of Photobiomodulation (PBM), which is the use of light therapy to stimulate cells using light emitting diodes (LEDs) of selected wavelengths. The Company has recently expanded their product lines to include two approved diagnostic devices for early detection and monitoring of eye disease.
The company has completed its US pivotal clinical trial and showed sustained vision improvements and slowing of disease. It markets their Valeda Light Delivery System in the EU and Latin America and is anticipating US approval in 2024.
Sanjeev Ganatra, Advisor, Corporate & Clinical - MediPrint Ophthalmics
MediPrint is an emerging San Diego-based clinical and regulatory stage eye care company that has developed a platform technology to treat ocular diseases, with a focus on improvement of contact lens comfort, treatment of glaucoma, dry eye, myopia, & other ocular conditions. MediPrint addresses ocular drug delivery with potential global market reach of $11b.
Leveraging its globally patented technology Mediprint has developed, clinically validated, and plans to commercialize its preservative-free, drug-eluting, sustained-delivery, comfort-enhancing contact lenses.
With more than 2.6m patients ($895m) who drop out annually due to contact lens related discomfort & dryness, Mediprint plans to offer a next generation of comfort contact lens & breakthrough options to improve patient comfort, convenience, and adherence with preservative-free sustained drug delivery. FDA approval of the comfort-enhancing lens with Hyaluronic Acid is expected in 2025.
Additionally, our technology platform has achieved the targeted endpoints in Phase II clinical trials for the effective & safe delivery of bimatoprost for the treatment of glaucoma patients with plans to expand to a Phase III. Mediprint's technology is a versatile platform opportunity for pharmaceutical companies, medical device companies, and optical companies to deliver drug in a novel way, to improve patient convenience, adherence, and improve ocular comfort.
Mediprint aims to develop and commercialize a deep product pipeline, supported by strong intellectual property, with a highly experienced and successful execution team.
Mackenzie Andrews, Chief Commercial Officer - Nanodropper
Nanodropper is a commercial-stage medical device company offering high-value solutions to adherence barriers in chronic eye disease management. The flagship product is a micro-volume delivery adaptor that reduces droplet volume and cost by more than 60% to increase access to vision-saving medications, elevate the user experience, and improve visual outcomes for older adults. It has been clinically validated through four clinical trials and has been demonstrated to be superior to the standard of care in IOP management, with an 80% reduction in early bottle exhaustion rates, and a 67% reduction in side effects. It can now be found through more than 2500 eye care clinics with customers including Mayo Clinic, Johns Hopkins, the VA system, and NASA.
David Almeida, MD, MBA, PhD - Near-Real Surgical Specimens
Near-Real Surgical Specimens (NRSS) is developed by the Centers for Advanced Surgical Exploration (CASEx) via the Knowledge-driven Engineered Precision for Healthcare Advancement of Lifesaving Operative Systems (KEPHALOS) project. KEPHALOS provides biologically-engineered specimens that respond dynamically to surgical manipulation. The objective is to introduce the discovery of Near-Real Surgical Specimens (NRSS), the first surgically-responsive ophthalmological biological specimens. This novel technology promises to revolutionize ophthalmic research and development and standardize surgical training by providing unparalleled realism and surgical feedback
Christian Roesky, PhD, CEO - Novaliq
Novaliq is a private biopharmaceutical company focusing on the development of first- and best-in-class ocular therapeutics. Novaliq developed EyeSol®, a novel drug category of water-free topical eye medicines. Two FDA-approved EyeSol medicinal products for dry eye disease - Miebo™ and Vevye™ - have recently been launched in clinical practices of eyecare professionals in the US and are beginning to revolutionize patient care. The EyeSol®-based products for dry eye disease are successfully partnered in major markets and are under regulatory review in several further countries and regions.
The Novaliq R&D pipeline provides multiple opportunities for development in ophthalmology and retina therapies.
Novaliq’s vision is to accelerate the company growth and pipeline expansion to build a leading eyecare biopharma company and is thus inviting Partners and Investors to join the success story and bring Novaliq to the next level.
Ran Yam, CEO & Co-Founder - NovaSight
Established in 2016, NovaSight is a growing medical device company with a mission to prevent vision impairments among pediatric patients using eye tracking based technology in novel diagnostic, therapeutic and preventive solutions, especially designed for the unique needs of children.
NovaSight focuses on three major verticals: vision treatment, vision diagnostics, and prevention and monitoring of visual health conditions.
Available in the US, Italy, Israel and China, the CureSight™ is an amblyopia treatment system, designed to replace the traditional eye patching. The treatment is carried out while the patient watches his favorite streamed content from the comfort of home.
The company raised to date $26M and following the FDA approval is now seeking $10M to $20M as its round B.
Jeff Franco, CEO - OcuDyne
We have developed reperfusion therapy for the eye. Ophthalmic artery stenosis is present in all AMD patients and we have demonstrated improved visual acuity in dry AMD patients treated with Ocudyne's therapy. We are able to dramatically improve the amount of blood getting to the eye.
Sanjay Nayak, MBBS, PhD, Chief Strategy Officer - Ocular Therapeutix
Ocular Therapeutix, Inc. is a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions. AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI), Ocular’s lead product candidate for retinal disease, is based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD).
Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis, and in its product candidate PAXTRAVA™ (travoprost intracameral implant or OTX-TIC), which has completed a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension.
Riad Sherif, MD, CEO - Oculis
Oculis is a global biopharmaceutical company purposefully driven to save sight and improve eye care. Oculis’ highly differentiated clinical-stage pipeline includes: OCS-01, a topical candidate in Phase 3 for diabetic macular edema and inflammation and pain following ocular surgery; OCS-02, a topical biologic candidate in Phase 2b for dry eye disease and uveitis; and OCS-05, a disease modifying candidate for acute optic neuritis and other neuro-ophthalmic disorders. Headquartered in Switzerland and with operations in the US, Oculis’ goal is to deliver life-changing eye treatments to patients worldwide. The company is led by an experienced management team and supported by leading international healthcare investors.
Connie Chang, MBA, Chief Operating Officer - ONL Therapeutics
ONL Therapeutics (ONL) is a clinical-stage biopharmaceutical company committed to developing first-in-class therapeutics to protect and improve the vision of patients with retinal disease. By advancing a breakthrough technology designed to protect key retinal cells from Fas-mediated cell death, ONL is pioneering a new approach to preserving vision. ONL is developing a platform of products for use in a wide range of blinding diseases, including retinal detachment, glaucoma, AMD and IRD.
Frederic Guerard, PharmD, CEO - Opthea, Limited
Opthea (ASX/NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
Opthea’s lead product candidate, sozinibercept, is being evaluated in two fully enrolled pivotal Phase 3 clinical trials (COAST, NCT04757636, and ShORe, NCT04757610) for use in combination with standard-of-care anti-VEGF-A monotherapies to improve overall efficacy and deliver superior vision gains compared to standard-of-care anti-VEGF-A agents.
James Rynerson, MD, CEO - Optivize
Established by an MD in 2012, BlephEx is a leader in new thinking regarding the care of dry eye and blepharitis. We discovered the biofilm etiology of lid margin disease and introduced BlephEx to the market in 2013 for lid debridement. BlephEx is now in 8,000 offices worldwide and 39 different countries. We then created LashCamiR to allow doctors to quickly and easily show patients their eyelid margins and meibomian glands in real time, helping to explain the need to eyelid debridement. Now comes OptiVize, a brand new way of attacking biofilm within the meibomian glands. Stemming from the work at Montana State University Center for Biofilm Engineering, Optimize uses a low voltage DC current to safely vaporize intraglandular biofilm, the true source of inflammatory lid disease.
Russell Trenary III, President & CEO - Outlook Therapeutics
Outlook Therapeutics is a biopharmaceutical company working to develop and launch ONS-5010/ LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan and other markets. Outlook Therapeutics expects to submit ONS-5010 ophthalmic bevacizumab to the U.S. FDA as a BLA under the PHSA 351(a) regulatory pathway.
Peter Francis, MD, Chief Medical & Scientific Officer - Ray Therapeutics
Ray Therapeutics Inc (RayTx) is a late-stage preclinical Bay Area biotechnology company pioneering the first-to-market precision optogenetic therapy for vision restoration that is highly active in ambient lighting (and will not require light-enhancing goggles). Our studies have shown for the first time that our proprietary ChRown optogenetic protein can restore high levels of visual acuity, contrast sensitivity and visual field.
RayTx lead asset, RTx-015, is expected to address the huge unmet medical in people suffering from many forms of retinal blindness (independent of the underlying genetic cause), including those with advanced age-related macular degeneration. RayTx has partnered with a world-leading AAV gene therapy manufacturer is utilizing their proprietary commercial manufacturing process and analytics to maximally de-risk clinical development. RayTx anticipates clinical trials will begin by the end of 2023 in our initial indication, retinitis pigmentosa.
Ram Palanki, PharmD, Executive Vice President, Commercial Strategy & Operations - REGENXBIO
REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy.
Our gene therapy product candidates are designed to deliver genes to cells to address genetic defects or to enable cells in the body to produce therapeutic proteins that are intended to impact disease. Through a single administration, our product candidates are designed to provide long-lasting effects, potentially significantly altering the course of disease and delivering improved patient outcomes.
We are currently developing gene therapy product candidates for the treatment of retinal, metabolic, and neurodegenerative diseases. Our product candidates all utilize AAV viral vectors from our proprietary gene delivery platform, which we call our NAV® Technology Platform. In addition to our internal product candidate programs, we also selectively license our NAV® Vectors to other leading biotechnology companies.
Jing-Feng Huang, Founder & CEO - Seinda Pharmaceutical Corporation
Seinda Pharmaceutical Corp. is a science-driven ophthalmic company dedicated to developing new therapeutics that address key underlying mechanisms of dry eye disease (DED) and other ocular diseases with significant unmet needs. We leverage our expertise in immunology, tear biomarker research and systems biology to identify the molecular mechanisms critical in DED and other target diseases. Seinda’s most advanced asset: SY-201 is a small peptide with multiple novel MOAs in restoring ocular surface integrity and homeostasis, recently completed phase 2 trial in US and achieved proof-of-concept. Seinda is preparing to advance SY-201 ophthalmic solution for DED into phase 3 in US and China in parallel.
Eric Schlumpf, President & CEO - Stuart Therapeutics
Stuart Therapeutics (Stuart) is a clinical stage pharmaceutical company focused on the development of a unique synthetic protein designed to target a previously undruggable target in the human body: helical collagen. The company’s platform technology, called PolyColTM (PolyCol), is a series of synthesized amino acid sequences designed to specifically bind to and repair disease-damaged helical collagen in the extracellular matrix and in membranes. These helical collagen structures play an important role in healthy tissues, including the regulation of inflammation, cell growth and proliferation, among many other processes.
Stuart was founded in 2018 to champion a new approach to the treatment of chronic diseases. Each of our founders has been affected directly or indirectly by chronic eye disease, and we have a passion for the pursuit of new and effective solutions for these indications.
Stuart’s areas of interest are Dry Eye Disease, Glaucoma, Dry Age-Related Macular Degeneration and Myopia.
Vincente Diaz, MD, Managing Member - Sustained Drug Delivery
Sustained Drug Delivery has developed a breakthrough platform technology that can release medicine as quickly as over two minutes and as long as over six months. We have had a successful Pre-IND meeting with the FDA to discuss an application of our technology to treat glaucoma. This will be a natural introduction to Ophthalmic applications such as dry eye, macular degeneration and diabetes. The technology has broad systemic indications as well.
Company's Website
Patricia Zilliox, Advisor - Theialife
Theialife is a virtual late-clinical stage novel ophthalmology drug company founded on an unyielding commitment to developing innovative breakthrough drug therapies for ophthalmological applications. Theialife's vision is to build a multi-asset clinical stage ophthalmology biotech. These therapies have unmatched potential to advance the existing standard of care to prevent sight deterioration, restore patient vision and enrich lives. Over the past 15 years, Theialife has advanced its lead candidate, ND10, through a Danish named-patient program that has shown promising efficacy in treating pediatric myopia. In addition to Neo Vascular AMD, UV-B Cataract Prevention, Dry Eye Disease, Pterygium, Corneal Blindness and Keratoconus, the company has expanded its research pipeline to address unmet ophthalmology needs. Theialife continues to challenge the status-quo in ophthalmology drug discovery and transform eye care worldwide.
Jeroen Wissink a.o., CEO - Uneedle
Uneedle, based in the Netherlands, specializes in designing and manufacturing advanced silicon microneedles for intradermal and suprachoroidal injections. Their proprietary technology, CE marked and FDA approved, enables precise and easy-to-use solutions for medical applications such as cancer vaccines and ophthalmic therapies. Uneedle's device platform facilitates efficient drug delivery with improved patient compliance. The company operates a GMP-compliant manufacturing site and is ISO13485 certified, partnering with pharmaceutical companies to enhance drug administration methods.
Wesley M. Jackson, President & CSO - Valitor
Valitor is overcoming limitations of existing drugs with established therapeutic targets by leveraging its multivalent polymer (MVP) technology. Using the MVP platform, multiple copies of bioactive molecules can be combined with individual biopolymer chains to create novel macromolecular entities that are engineered to overcome a multitude of specific challenges, including optimized pharmacokinetic/pharmacodynamic properties, tissue localization, therapeutic durability, and safety. Accordingly, the company’s lead program, a novel anti-VEGF antibody treatment for wet AMD, is positioned to overcome long-standing drug development challenges with the potential of enabling reliable twice-yearly treatment for most if not all patients. Valitor has designed its MVP platform with interchangeable bioactive molecules and biopolymers, which enables Valitor to leverage validated clinical mechanisms to generate new compounds optimized to treat additional indications in ophthalmology as a part of its internal pipeline or with our partners.
Juan Pablo Robles, CEO & founder - VIAN Therapeutics
VIAN Therapeutics is an emerging biotech developing VIAN-c4551, a first-in-class cyclic peptide with exceptional potency and ocular penetration, administered via daily eyedrops for treating microvascular retinal diseases such as DME and wet AMD. VIAN-c4551 targets endothelial cells in the microvasculature at the back of the eye to inhibit VEGF and Ang-2 signaling pathways with picomolar concentrations. This technology, based on decades of vascular biology research and natural angiogenesis inhibitors, is backed by strong preclinical data, with clinical trials on the horizon. Positioned to disrupt a $15B market, VIAN aims to replace invasive ocular injections with a simple, non-invasive solution.
Thomas Ciulla, MD, MBA, Chief Medical Officer - Viridian Therapeutics
Viridian Therapeutics is developing potential best-in-class medicines for people living with autoimmune and rare diseases, including multiple clinical candidates for the treatment of thyroid eye disease (TED). Viridian aims to advance VRDN-001 as a differentiated intravenous therapy and VRDN-003 as a potential best-in-class subcutaneous therapy for the treatment of TED.