We address significant unmet medical needs with a portfolio of products and product candidates, which are in various commercial and clinical stages, including:
- Eye-D, an in-office insertable platform that provides for controlled release of ophthalmic medications over time, thereby resolving poor compliance with eye-drop treatment regimens and permitting 100% patient compliance with drug therapy regimens. Our first product candidate utilizing the Eye-D platform, the VS-101, contains the most prescribed glaucoma medication, latanoprost. We believe that the Eye-D platform can be further developed to treat various other ocular conditions. The VS-101 concluded a Phase 1/2a clinical study in the United States as part of a new drug application under the FDA 505(b)(2) regulatory pathway process.
- IOPtiMate, a commercialized, novel surgical system that enables a non-penetrating, CO2 laser-assisted procedure known as CLASS (CO2 Laser-Assisted Sclerotomy Surgery) to reduce elevated IOP. CLASS is an, automated, easy-to-perform procedure which requires only a short learning curve and provides a safer and more precise alternative to the currently complex and risky glaucoma surgeries. As a result, we believe that IOPtiMate may also enable a wider range of ophthalmic surgeons to perform glaucoma surgeries, and has the potential to replace existing glaucoma medical procedures and drive an increase in the quantity and quality of glaucoma surgeries worldwide. In addition to initial sales primarily in Asia and Europe, we have entered into distribution agreements for sales of IOPtiMate in additional countries outside the United States.
We have concluded so far thousands of successful commercial procedures. In November 2017, we have entered a binding agreement for the investment in and the acquisition in stages of IOptima by Chengdu Kanghong Pharmaceutical Group. First stage of these deals was completed.
- TeaRx, a diagnostic solution that provides a multi-parameter, objective, rapid, simple, semi-quantitative analysis of tear film in order to identify one or more underlying causes of DES. We believe TeaRx has the potential to be both a clinically valuable point-of-care test as well as a companion diagnostic test that addresses the need for rapid testing and personalized medicine. We expect TeaRx to be a cost-effective, easy-to-use and objective solution that will allow eye-care professionals to diagnose and treat patients who suffer from symptoms of DES, including those who may otherwise be undiagnosed or unidentified. We have completed three TeaRx clinical trials in the United States and intend to initiate a 510(k) pivotal trial with the FDA in 2016, and, if cleared, we expect to begin global sales in 2019.
We also have two collaborations for companion diagnostics applications.
- OphRx, our joint venture which licensed a non-invasive topical drug delivery technology utilizing LLC, administered through eye drops as an alternative to the current delivery modalities, such as intravitreal injections, used to treat diseases at the back of the eye. This platform technology can also be used for front of the eye treatments. OphRx is currently in the pre-clinical stage of development of few product candidates.
- LIPITEAR™, a micro-emulsion consists of phospholipidis and triglycerides which forms a tear film-like elastic lipid shield, a class III medical device, certified with a CE. LIPITEAR™ is indicated for use for ocular surgery post-operative (e.g. refractive surgery, cataract surgery and corneal transplant), corneal erosions and Dry eye Syndrome. LIPITEAR™ is the only product in the eye drop market with a clinically proven indication of enhancement of corneal re-epithelization following mechanical, traumatic and surgical epithelial loss.
Being a micro-emulsion vehicle, the technology can be used as a drug delivery platform, which is in pre-clinical stages.
Its unique pharmaceutical advantages include:
- Longer contact time between the drug and the eye surface, increasing compliance.
- Dual treatment – dry eye treatment + treatment of other ocular diseases using one eye drop.
- Potential slow release capabilities with lipid solubility drugs.
Our goal is to become the leading ophthalmic company in the world by building a diverse and balanced portfolio of innovative products and product candidates, establishing a sales force to maximize the commercial potential of our products and maintain a global, diverse network of ophthalmic specialists to accelerate knowledge synergies and innovation. Our network of ophthalmic specialists has enabled us to develop our current products and product candidates in a relatively short time period and in a cost-effective manner. We plan to add products and product candidates to our pipeline by expanding our current technology platforms to additional indications and through in-licensing and investing in new platform technologies.