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Venture capital community vital to advances in ophthalmology
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 Richard L. Lindstrom |
Under the leadership of three venture capitalists who are committed to supporting innovation in ophthalmology, Emmett T. Cunningham, MD, PhD, MPH, William J. Link, PhD, and Gil Kliman, MD, two Ophthalmology Innovation Summits have been orchestrated just prior to the American Academy of Ophthalmology meetings. Each of these all-day symposia highlighted the road map for negotiating the innovation cycle to bridge the translational gap between new ideas and bench research to commercial products that preserve, restore or enhance vision.
The pathway for devices that require U.S. Food and Drug Administration premarket approval now typically measures 8 to 12 years and $80 million to $120 million to navigate. For a novel new drug, the timeline is even longer, and cost can reach the almost unbelievable $500 million to $2 billion threshold. Many large strategic companies have found that the most economically viable pipeline for new product development is through venture capital-supported startup companies. In some cases, they have invested alongside the venture community in select new technologies.
With the IPO market closed to most startups, we are fortunate indeed that the venture capital community has found ophthalmology interesting. Companies that have successfully commercialized with venture capital support include IntraLase, eyeonics and LenSx. On the near horizon, among others, are Visiogen, LensAR, OptiMedica and Glaukos. Most of these companies are investing in age-related eye disease, including spectacle-, cornea- and lens-based solutions for presbyopia, minimally invasive glaucoma surgery, retinal disease, cataract, and ocular surface disease. With the global population aging, these areas promise strong returns for successful technologies.
I am very excited about a few of these opportunities. PixelOptics is launching an electronic spectacle for presbyopia called EmPower that promises to be disruptive in this huge and lucrative market. Three companies with intracorneal lenses for presbyopia, AcuFocus, ReVision Optics and Presbia, are working their way through regulatory barriers worldwide while launching in select countries. I just returned from Tokyo where I watched Minoru Tomita, MD, PhD, operate on two prominent ophthalmologists with the AcuFocus Kamra, with both patients achieving 20/16 distance vision, J2 near vision and high patient satisfaction within 1 week after surgery. Both were back in the OR in less than a week with full function. (This story will follow in an upcoming issue of Ocular Surgery News.)
Femtosecond laser-assisted refractive cataract surgery promises to be a $1 billion market in less than 5 years and may well affect refractive cataract surgery much as the transition from incisional to laser-based refractive corneal surgery did 2 decades ago. Various accommodating and electronic options for IOL implants are in development and are fortunately well-funded by combinations of venture capital and strategic company investment. These include Quest, PowerVision, NuLens, Adoptics, AkkoLens and Elenza. Together, nearly $500 million and an enormous commitment of human brain power are at work developing the next generation of lens-based treatments for presbyopia. The Calhoun light-adjustable IOL and intraoperative aberrometry pioneered by WaveTec and Clarity promise improved refractive outcomes. Glaukos, Transcend, AqueSys, iScience and others are investing heavily in minimally invasive glaucoma surgery, and I can imagine the day these technologies allow elective glaucoma surgery as an option to medical therapy for those suffering from glaucoma. The advance in treatment for AMD, diabetic retinopathy, vein occlusion and retinal blindness treatment with artificial sensors is breathtaking. Much effort is being expended to make drug delivery less invasive and more reliable. Finally, ocular surface disease, including dry eye, blepharitis and ocular allergy, which constitutes 30% to 40% of an ophthalmologist’s office practice, is experiencing multiple new drug and device launches.
While regulatory barriers in the U.S. remain a challenge, many new products can successfully launch in the much more reasonable CE mark environment enjoyed in Europe. Because 60% of the global market is now outside the U.S., it is possible to build successful companies without participation in the U.S. market. While not ideal for the American surgeon or patient, this new reality creates tremendous opportunity and competitive advantage to innovators outside of the United States. It is hoped that efforts to “harmonize” regulatory processes worldwide will lead the U.S. to emulate Europe rather than the alternative, as there is no evidence that the extremely more expensive and time-consuming regulatory barriers in the U.S. generate any benefit to patients, doctors or industry.
Those who are interested in innovation should consider participation in the next Ophthalmology Innovation Summit. We are fortunate indeed to have a healthy pipeline of new products in our field, as innovation is critical if the next generation is to enjoy better health than the current one.