Alimera Sciences has received a "complete response" from FDA for its lead product candidate Iluvien and expects to resubmit its NDA for the drug/device combo in the first quarter.

Iluvien (formerly Medidur) is an intravitreal implant containing the corticosteroid fluocinolone acetonide, meant for the treatment of diabetic macular edema (DME). Australian drug maker pSivida developed the implant and licensed it to Alimera in 2005.

"The issues were fairly well-enumerated regarding the reasoning for seeing the 36[-month data] versus 24[-month data]," said Alimera President and CEO Dan Myers during a conference call Dec. 27. "Obviously, safety and efficacy and the risk-benefit is clearly the driving issue here, and I guess clarification on what the FDA is going to need to give them the clarity to adequately assess safety/efficacy [at] 24 months versus 36."

If approved, Iluvien would be the first drug/device combo available for a disease that affects about 19% of the diabetic population, which is expected to double over the 10 years. The current standard of care for the treatment of DME is laser photocoagulation, which can cause partial loss of peripheral and night vision. Although not as large as the overall diabetes market, the opportunity in DME is significant. Alimera estimates about 340,000 cases of DME arise annually in the U.S.

Alimera filed the NDA for Iluvien in June 2010 and received a priority review in August. The filing was based on 24 months of data from the FAME trial, a three-year study of 956 patients conducted across multiple sites in Europe, North America and India that was completed in October.

The agency said in its "complete response" that it found the 24-month data insufficient and asked for an analysis of the third year of data, as well as further information regarding the manufacturing, packaging and sterilization of the drug. FDA did not request further clinical trials - an expensive process that would have pushed approval back by several years.

Alimera has requested a Type A meeting with FDA in early February to further discuss the agency's recommendations for approval.

In regards to the manufacturing issues, Myers said "those don't appear to present any problem that would be a gating issue for us. I think all of those are really matters of communication and some small issues that we don't think are significant, and should be all accomplished within the submission period."

Alimera One Of 2010's Successful Biotech IPOs

While the ophthalmology field has been a hot area for venture investors over the last few years due to the high unmet medical need and potential market size, exits have not been easy to find ('Venture Eyes Ophthalmology - And Likes What It Sees,' 'Start-Up,' October 2009).

After a few failed earlier attempts to go public, Alimera opted to take its shot at the market in April. The ophthalmology company grossed $72.1 million in its April 21 initial public offering; the sixth biotech to debut in 2010. Yet, like many of its biotech brethren that have taken the plunge in recent years, Alimera was forced to slash its per-share price to $11, 31% below the $15 to $17 range it touted in early April.

The Alpharetta, Ga.-based biotech also bumped the number of shares from 6 million to 6.6 million, but 1.8 million of them were bought by existing venture backers, including Domain Associates, Intersouth Partners and Polaris Venture Partners, which have put about $94 million into Alimera since it was founded in 2003 ('Alimera Raises $72 Million In IPO; Clips Share Price To $11 From Initial $15-$17 Range,' 'The Pink Sheet' DAILY, April 22, 2010).

Most of the IPO proceeds were directed toward the Iluvien program. Alimera also used the proceeds to pay back $15 million of debt pSivida is holding, plus an additional $175,000 in accrued interest. If Iluvien is approved, pSivida will earn a $25 million milestone payment.

-Lisa LaMotta (l.lamotta@elsevier.com)

FDA Issues "Complete Response" On Alimera's Iluvien; Eyes More Data

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