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allowing patients to drop out of the trial prematurely. The company also started measuring the response to the drug 12 weeks into the 24-week trial, rather than waiting until patients have been on it for 16 weeks. “We improved the study design to give us a greater probability of being successful,” Mitchell says.
Lux is testing voclosporin in conjunction with oral steroids, which are commonly prescribed to patients with uveitis. Because high doses of steroids are dangerous—they can cause adverse events ranging from diabetes to osteoporosis—ophthalmologists who treat the disease try to keep patients on the tiniest doses possible. “Our idea is by adding voclosporin, you can taper the steroids down,” Mitchell says.
Upon its founding, Lux raised $36 million from HBM Partners, Novo, Prospect Venture Partners, and SV Life Sciences. It raised a $50 million Series B round led by those investors in 2009. Mitchell says Lux’s investors recently put an undisclosed amount of funding into the company that would take it through FDA approval. After the new trial is completed, the company will weigh its options, which could range from inking commercialization partnerships to getting acquired outright, he says.
Investors, both private and corporate, have taken notice of ophthalmology of late—a trend that could help Lux as Mitchell’s team goes on the hunt for more funding. Last fall, New York-based biotech startup Imagen, which is developing a drug to treat age-related macular degeneration, raised $40 million in a Series A financing led by SV Life Sciences, Fidelity Biosciences, and Novo. Seattle-based Acucela has also raised $40 million and is gearing up for a late-stage trial in macular degeneration. Several Big Pharma companies, including Sanofi and GlaxoSmithKline, have been investing in eye products, too.
Mitchell saw firsthand how hot ophthalmology drug development can be, when, earlier this year, Bausch & Lomb agreed to buy cataract drugmaker Ista Pharmaceuticals for $500 million. Mitchell was a member of Ista’s board of directors. “It’s very clear there’s been quite a lot of consolidation of small ophthalmology companies,” Mitchell says. “I think if we choose to go in that direction, there will be some interest.”
Mitchell believes hunkering down for two years to complete the new trial was the best possible path Lux could have taken. “The company had a pretty high profile. There were expectations of approvals and discussions with other companies about potential partnerships,” he says. “I felt we needed to pull back from all that and get our act together.”