Ocular Therapuetix Fast Facts
Eye Incision Sealant
- Ocular’s eye incision sealant awaits FDA Approval
- Estimated U.S. cataract surgery procedures, 4 million annually
Eye Drug Delivery
- Novel eye drug delivery device nears Phase 3 trials
- First product testing in glaucoma, a $5 billion market opportunity
By Sony Salzman
Masters in Science Candidate
Boston University Science Writing Program
At innovative eye-care company Ocular Therapeutix, the company awaits perhaps its most important milestone, namely FDA approval of its first product—a potential new standard of care therapy to seal incisions following eye surgery.
Product approval, anticipated before the end of 2013, would allow Ocular to muscle into the ophthalmology world and join an estimated $10 billion market traditionally dominated by giants Alcon (owned by Novartis), Allergan and Pfizer. It would also support the rapid development of a second novel product in Phase 2 testing that could radically change the way drugs are delivered for glaucoma and other ophthalmic diseases.
Guiding these programs is repeat entrepreneur Amar Sawhney, Ocular’s founder and CEO, who has a proven track record of developing game-changing therapies. At Confluent Surgical, for example, Sawhney used synthetic polymer technology to create hydrogel sealants for both cranial and spinal surgery. These surgical sealants became standards of care and are widely used today. At another start-up biotech, Focal, Inc., Sawhney created the first lung sealant to be approved by the FDA. These clinical advancements led to the acquisitions of Confluent Surgical by Covidien and Focal, Inc. by Genzyme.
“Amar is a force of nature,” said Ocular board member Alan Crane, a general partner at Polaris Partners and co-founder and former CEO of Momenta Pharmaceuticals. “He’s a successful repeat entrepreneur that continuously goes after big challenges rather than incremental advances. That’s really what society is looking for, and what we as his venture partners seek as well.”
Using his experience with hydrogel polymer technology at Ocular, Sawhney and his team are taking on some of the biggest challenges in eye care. “We see significant opportunity to apply hydrogel technology to ocular surgery and to deliver drugs to the eye,” said Sawhney. “This is the sweet-spot for this technology.”
Solving the Incision Dilemma
Cataracts are the most common cause of blindness worldwide and are conventionally treated with surgery. In the United States, there are well over 4 million surgical procedures annually to remove the natural lens of the eye that has developed an opacification, or cataract.
Closing incisions associated with cataract surgery poses a dilemma for ophthalmologists. They can use a technique known as stromal hydration, where the physician injects a saline-like product to inflate tissue and close the wound. Alternatively, physicians can use sutures, which add to patient discomfort and leak nearly 25 percent of the time. Both procedures can lead to post-operative complications that may ultimately impair vision.
Ocular’s ReSure Sealant addresses the healing dilemma for cataract surgery and other procedures involving corneal incisions. The hydrogel sealant works by coating eye incisions after surgery, which prevents ocular leaks. Over time, the hydrogel-based sealant sloughs off and is cleared by tears.
Sawhney says that developing sealant technology for the eye has been very challenging. “For brain surgery, you seal the dura with five milliliters. For the eye, you can use only five microliters, so a 1,000 fold reduction in the amount of material,” said Sawhney. “The eye is also very sensitive, and the patient can directly experience it. So the compatibility takes on a whole new meaning in the eye because the patient can actually feel it.”
Ocular has conducted a large Phase 3 trial going head-to-head against suture procedures. While the results were included in the company’s FDA submission, to avoid pre-product approval publicity complications, the company has chosen to wait until after FDA approval to publicly announce it. Sawhney, however, calls the data “promising.”
Overcoming the Rx Patient Compliance Challenge
But perhaps the larger market opportunity for Ocular may be its eye drug delivery device, known in the industry as a “punctum plug.” These devices are created with the same hydrogel technology, formed in a spiral shape that is inserted into the tear duct to slowly disperse drugs into the eye. This product has the potential to replace the current practice of patients administering drugs with eye drops at home. The plug may help solve a crisis in treating chronic eye disease, namely patient compliance.
According to Eliot Lazar, ophthalmologist and President of elCON Enterprises, patient compliance for glaucoma treatments drops to 50 percent after three months. “Because of that number and that number alone, when someone comes along with a therapy like [Ocular’s plug], it’s going to be very promising,” said Lazar. “[Their plug] program is furthest along and has what many consider the best data.”
Many companies have previously tried and failed to develop tear-duct plugs that slowly disperse drugs into the eye. Earlier failures didn’t deliver enough drug, or the plugs where misshaped, irritating the eye or falling out of the tear duct too easily.
To develop plugs that were comfortable and stayed put, the company’s researchers spent a great deal of time working with patients of all body types. They also worked through many thousands of hydrogel casting iterations to get the optimum composition to allow the release of a drug’s active compound.
“We don’t take a one size fits all type of approach,” Sawhney said. “We fundamentally analyze what is needed and then use our technology’s flexibility to design the appropriate product.”
Ocular’s first plugs are currently being tested to treat glaucoma, but the plug could also be used to treat allergies, dry eye or inflammation. The company is completing a series of Phase 2 trials to establish effective dosing and to show that the plugs can hold for three months—the typical ophthalmologist patient visit cycle. Data from the Phase 2 trials will inform the development of a pivotal Phase 3 trial.
While Sawhney has developed therapies for other clinical areas, he finds the eye care field the most rewarding. “I really enjoy tackling this new field of eye disease because of all of the five senses, patients value vision the most,” said Sawhney. “If we can make an impact in either of the areas we are working in, it will be fantastic.”
Ocular Therapuetix CEO Amar Sawhney awarded the Outstanding American by Choice Award