Iluvien Clinical Development Program and certain risk factors relating to the Iluvien Clinical Development program from Form S-1/A of Alimera, Registration No. 333-162782, filed

Iluvien Clinical Development Program and certain risk factors

relating to the Iluvien Clinical Development program from

Form S-1/A of Alimera, Registration No. 333-162782,

filed December 23, 2009

Clinical Development Program

The following table summarizes current and planned clinical

Program for the Treatment of DME

We are currently conducting two Phase 3 pivotal clinical trials

(individually referred to as Trial A and Trial B, and

collectively as our FAME Study) for Iluvien involving

956 patients in sites across the United States, Canada,

Europe and India to assess the efficacy and safety of Iluvien in

the treatment of DME. Combined enrollment was completed in

October 2007, and the month 24 clinical readout from our FAME

Study was received in December 2009. We believe that the month

24 data supports approval of the low dose of Iluvien for the

treatment of DME. Therefore, we plan to proceed with the

preparation of a registration dossier and to submit an NDA in

the United States for the low dose of Iluvien to the FDA in

the second quarter of 2010 with the month 24 clinical data,

followed by registration filings in certain European countries

Consistent with the FDA requirement for registration and

approval of drugs being developed for diabetic retinopathy,

including DME, the primary efficacy endpoint for our FAME Study

is the difference in the percentage of patients whose best

corrected visual acuity (BCVA) improved from baseline by 15 or

more letters on the Early Treatment Diabetic Retinopathy Study

(ETDRS) eye chart between the treatment and control groups at

month 24. The ETDRS eye chart is the standard used in clinical

trials for measuring sharpness of sight as established by the

National Eye Institute s Early Treatment Diabetic

Retinopathy Study. In addition, the FDA requires a numerical

comparison of the percentage of patients with BCVA improvement

of 15 or more letters between the month 24 and month 18 data to

determine if the month 24 results are equal to or greater than

the month 18 results. Patients enrolled in our FAME Study will

be followed for 36 months. Although we will submit the

additional 12 months of clinical data to applicable regulatory

authorities, the approval of Iluvien by regulatory authorities,

including the FDA, will be based on the month 24 clinical data

from our FAME Study.

We believe that Iluvien meets the requirements for Priority

Review in the United States and we intend to make a formal

request for this review classification when we file our NDA with

the FDA. Upon receipt, the FDA will notify us within

60 days of Iluvien s final review classification. In

the European Union, we will be utilizing the

decentralized registration procedure. The Iluvien insertion

system will not require a separate device application, but it

must meet the safety and regulatory requirements of the

applicable regulatory authorities when evaluated as part of the

drug product marketing application.

We initiated our FAME Study in September 2005. Trial A and Trial

B have identical protocols and completed enrollment in October

2007 with a total of 956 patients across 101 academic and

private practice centers. Trial A drew patients from sites

located in the northern regions of the United States, Europe and

India and all sites in Canada, while sites in the southern

regions of the United States, India and Europe comprise Trial B.

Our FAME Study was designed to assess the safety and efficacy of

Iluvien in patients with DME involving the center of the macula,

and who had at least one prior macular laser treatment

12 weeks or more before study entry. The inclusion criteria

for our FAME Study were designed to select DME patients with

BCVA between 20/50 (68 letters on the ETDRS eye chart) and

20/400 (19 letters on the ETDRS eye chart) in the study eye

and no worse than 20/400 in the non-study eye. Patients who had

received steroid drug treatments for DME within three months of

screening or anti-VEGF injections within two months of

screening, and patients with glaucoma, ocular hypertension, IOP

greater than 21mmHg or concurrent therapy with IOP-lowering

agents in the study eye at screening were not eligible to

participate in this trial.

The following table describes the baseline characteristics of

the patients randomized into our FAME Study.

Patient characteristics, such as age, gender and baseline BCVA,

were balanced across the treatment and control groups. As part

of randomization, the patients were divided into two separate

groups, those with a baseline BCVA score greater than or equal

to 49 letters on the ETDRS eye chart and those with a baseline

BCVA score of less than 49 letters on the ETDRS eye chart.

We randomly assigned patients participating in our FAME Study to

one of three groups at a ratio of 2:2:1. The first two of these

groups were assigned to an active drug formulation and the third

group serves as the control group, undergoing a sham insertion

procedure designed to mimic an intravitreal insertion. The

treatment groups consist of one group receiving a low dose of

Iluvien and another group receiving a high dose of Iluvien. To

reduce potential bias, these trials use a randomized,

double-masked study design so that neither the patient nor the

investigational staff involved with assessing the patient knows

to which group the patient belongs. In order to simulate an

insertion and help to maintain proper patient masking, the sham

insertion procedure includes all steps involved in the insertion

procedure, except that a blunt inserter without a needle is used

to apply pressure to the anesthetized eye.

As part of our FAME Study, investigators were able to re-treat

each patient with Iluvien following their month 12 follow up