Our ophthalmic portfolio is held by XLVision, a fully owned subsidiary of BioLight.
We plan to address these significant unmet medical needs with a pipeline 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 is currently in 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, the results of which are expected to be obtained by the third quarter of 2016.
- 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 intend to seek FDA review of the IOPtiMate system [through a 510(k) de novo regulatory pathway process] in 2016, and, if approved, we expect to begin sales in the United States in 2019.
- 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 two TeaRx clinical trials in the United States and intend to initiate a 510(k) regulatory pathway process with the FDA in 2016, and, if cleared, we expect to begin sales in the United States in 2017.
- 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 two product candidates: OPH-101, an alternative topical treatment to intravitreal injections for wet AMD, and OPH-100, a treatment for DES.
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.