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Shire, which built its experience in biotech agents, is taking a biotech approach to meeting unmet needs in both the anterior and poster segments of ophthalmology.
Dry eye has a new class of treatment, lifitegrast (Xiidra, Shire). Approved in 2016, it is the first, and the only, lymphocyte function-associated antigen-1, or LFA1 antagonist, on the U.S. market.
“We received approval of July 11 and went to market on August 29,” said Robert J. Dempsey, MBA, vice president and U.S. franchise head, Ophthalmics, Shire. “As we closed 2016, we had generated over 200,000 prescriptions and attained a market share of 20%. If you look at new-to-brand prescriptions, new patients put on the drug, we obtained over 50% market share. Since approval and going to market, we have seen the market for dry eye disease increase by over 45%.”
Dempsey focused on the success of lifitegrast in an Industry Spotlight session during the New Horizons Forum, held in conjunction with the 2017 Glaucoma 360 meeting.
There is a significant unmet need in dry eye as well as in glaucoma, age-related macular degeneration, and other ocular disease associated with aging,” Dempsey pointed out. Relatively few companies are targeting these conditions and none bring Shire’s experience in finding solutions in rare diseases and specialty.
Shire, which built its experience in biotech agents, is taking a biotech approach to meeting unmet needs in both the anterior and poster segments, Dempsey added.
Lifitegrast is a twice daily ophthalmic topical drug indicated for both the signs and the symptoms of dry eye. It is marketed in single-use containers, 60 per foil pouch, for a 30-day supply.
Like other ophthalmic agents, lifitegrast has side effects. The most common adverse events are dysguesia, slight burning or stinging upon installation, or blurred vision.
The safety profile was based on 5 clinical trials with about 1,400 patients, Dempsey noted. Most of the patients, about 84%, had 3 months of exposure. The remaining 16% had longer exposure, including 170 patients who underwent 12 months of treatment.
Early and clear communication with patients is the important step in managing these side effects.
“When physicians have these discussions with patients upfront, these significant adverse events seem to be well-tolerated by patients,” Dempsey said. “To set patients up for success, we highly recommend having the discussions in advance and avoiding surprises.”
Four clinical trials
Lifitegrast was evaluated over 4 clinical trials in over 2,200 patients, including 3 phase III trials with about 2,000 patients. Trials evaluated safety and efficacy, including the safety of the vehicle. Signs of dry eye were evaluated using corneal staining and symptoms using the standard dryness score.
The average baseline dryness score at baseline was between 40 and 70 on a 100-point scale. A statistically significant reduction in dryness score favoring lifitegrast was seen in all 4 studies at week 6 and week 12.
Symptom improvement was noted in as little as 2 weeks in 2 studies. There was a statistically significant reduction in corneal staining at 12 weeks in 3 of the 4 studies.
Shire has already filed for lifitegrast marketing approval in Canada and plans filings in multiple global markets by the end of 2017. The company is also developing new products for other ophthalmic indications.
“We have a high level of commitment from our CEO and board of directors to become a major player in the ophthalmic space,” Dempsey said. “Our core focus is the new chemical entities that will address those significant unmet needs in the ophthalmic space.”