ALIMERA SCIENCES FACT SHEET

Transcription

1 ALIMERA SCIENCES FACT SHEET VERVIEW Alimer Sciences, Inc. (NASDAQ: ALIM), sed in Alphrett, GA, is phrmceuticl compny tht specilizes in the reserch, development nd commerciliztion of prescription ophthlmic phrmceuticls. Alimer Sciences Limited, susidiry of Alimer, is sed in the United Kingdom nd is the hedqurters of Alimer's Europen opertions. The compny lso opertes susidiries in Germny nd Portugl. Presently, the compny is focused on diseses ffecting the ck of the eye, or retin. (fluocinolone cetonide intrvitrel implnt).19 mg is the compny s led product. is multiyer intrvitrel (in the vitreous of the ck of the eye) nonioerodle implnt, which is sustined drug delivery system tht provides continuous, dily sumicrogrm level of fluocinolone cetonide lsting for 3 months. is pproved in the United Sttes to tret dietic mculr edem in ptients who hve een previously treted with course of corticosteroids nd did not hve cliniclly significnt rise in introculr pressure. is lso pproved in Austri, Belgium, Denmrk, Finlnd, Frnce, Germny, Irelnd, Itly, Luxemourg, Netherlnds, Norwy, Portugl, Spin, Sweden nd the United Kingdom where it is indicted for the tretment of vision impirment ssocited with chronic dietic mculr edem, considered insufficiently responsive to ville therpies. is in the ntionl licensing phse in two dditionl Europen countries, the Czech Repulic nd Polnd. It is ville commercilly in the U.S., Germny, Portugl nd the United Kingdom. MANAGEMENT TEAM Dn Myers, President nd Chief Executive fficer Rick Eiswirth, Chief perting fficer nd Chief Finncil fficer Philip Ashmn, Ph.D., Senior Vice President, Europen Mnging Director Ken Green, Ph.D., Chief Scientific fficer, Glol Hed, Reserch & Development Dve Hollnd, Senior Vice President, Sles nd Mrketing EU MANAGEMENT TEAM Philip Ashmn, Ph.D., Senior Vice President, Europen Mnging Director John Hll, MD, Senior Vice President, Medicl Director Europe Philip Hldr, Vice President, Europen Mrketing LEAD PRDUCT is long-term, sustined-relese intrvitrel implnt. A single, tiny implnt is designed to deliver sumicrogrm levels of the corticosteroid, fluocinolone cetonide (FAc), for 3 months. Corticosteroids hve history of effective use in treting inflmmtion. is injected into the ck of the eye with n pplictor tht employs 5-guge needle, which llows for self-seling wound. In the two phse 3 clinicl trils, known s the FAME Studies, the most frequently reported dverse drug rections included ctrct development nd incresed oculr pressure. Lst updted Ferury 3, 15.

2 IMPRTANT SAFETY INFRMATIN CNTRAINDICATINS is contrindicted in ptients with ctive or suspected oculr or perioculr infections including most virl diseses of the corne nd conjunctiv including ctive epithelil herpes simplex kertitis (dendritic kertitis), vccini, vricell, mycocteril infections nd fungl diseses. is contrindicted in ptients with glucom, who hve cup to disc rtios of greter thn.. is contrindicted in ptients with known hypersensitivity to ny components of this product. WARNINGS AND PRECAUTINS Intrvitrel injections hve een ssocited with endophthlmitis, eye inflmmtion, incresed introculr pressure, nd retinl detchments. Ptients should e monitored following the intrvitrel injection. Use of corticosteroids my produce posterior sucpsulr ctrcts, incresed introculr pressure, glucom, nd my enhnce the estlishment of secondry oculr infections due to cteri, fungi, or viruses. Corticosteroids re not recommended to e used in ptients with history of oculr herpes simplex ecuse of the potentil for rectivtion of the virl infection. Ptients in whom the posterior cpsule of the lens is sent or hs ter re t risk of implnt migrtion into the nterior chmer. ADVERSE REACTINS In controlled studies, the most common dverse rections reported were ctrct development ( %; shm 5%) nd introculr pressure elevtion of >1 mmhg ( 3%; shm 1%). Ptients re dvised to hve follow-up eye exmintions t pproprite intervls following tretment with. For full prescriing informtion, log onto You re encourged to report negtive side effects of prescription drugs to the FDA. Visit or cll 1--FDA-1. Plese see Full Prescriing Informtion elow. CRPRATE TIMELINE 3: Alimer Sciences is founded y severl former Novrtis phthlmics executives. : Soothe, n TC product tht provides relief to sufferers of dry eye, is lunched. 5: The FAME Study for for the tretment of dietic mculr edem is initited. : Alimer gins FDA New Drug Appliction (NDA) pprovl for n Rx-to-TC switch of n nti-llergy eye product clled Alwy ketotifen fumrte ophthlmic solution. Alwy is sold to Busch nd Lom. 7: Soothe is sold to Busch nd Lom. 1: Alimer Sciences goes pulic, trding under the NASDAQ symol ALIM. 1: receives positive opinion for pprovl of its Mrketing Authoriztion Appliction (MAA) from seven Europen countries vi the Decentrlized Procedure (DCP). 13: is commercilly lunched in Germny nd the United Kingdom. 13: The United Kingdom's Ntionl Institute for Helth nd Cre Excellence (NICE) pulished finl guidnce for, clering the pth to ptient vilility through the Ntionl Helth Service (NHS). 1: Through the Repet Use Process in Europe, Alimer receives positive opinion to pprove in 1 dditionl Europen countries nd receives ntionl mrketing licenses in eight. 1: pproved in the United Sttes y the Food nd Drug Administrtion (FDA). 15: commercilly lunched in the U.S. in lte Ferury. Lst updted Ferury 3, 15.

3 FINANCIAL INFRMATIN (s reported in the 1-Q dted Novemer 1, 1) Alimer Sciences, Inc. is pulicly trded on NASDAQ under the symol ALIM. Net revenue for the three months ended Septemer 3, 1 incresed y pproximtely $1. million, or 11%, to pproximtely $. million compred to pproximtely $7, for the three months ended Septemer 3, 13. The increse ws ttriutle to incresed doption of in Germny nd the United Kingdom. As of Septemer 3, 1, Alimer hd csh nd csh equivlents of $1. million, compred to $1. million s of Septemer 3, 13. LCATINS Alimer Sciences, Inc. 1 Windwrd Prkwy, Suite 9 Alphrett, GA 35 Alimer Sciences Limited Royl Pvilion Wellesley Rod Aldershot Hmpshire GU11 1PZ United Kingdom T: +1 (7) F: +1 (7) T: + ()15 35 F: + () CNTACTS For press inquiries: Audr Friis, Pscle Communictions udr@psclecommunictions.com For investor inquiries: Dvid Burke, The Ruth Group durke@theruthgroup.com For more informtion, visit Lst updted Ferury 3, 15.

4 HIGHLIGHTS F PRESCRIBING INFRMATIN These highlights do not include ll the informtion needed to use sfely nd effectively. See full prescriing informtion for. (fluocinolone cetonide intrvitrel implnt).19 mg For Intrvitrel Injection Initil U.S. Approvl: 193 INDICATINS AND USAGE contins corticosteroid nd is indicted for the tretment of dietic mculr edem in ptients who hve een previously treted with course of corticosteroids nd did not hve cliniclly significnt rise in introculr pressure. (1) DSAGE AND ADMINISTRATIN For ophthlmic intrvitrel injection. (.1) The intrvitrel injection procedure should e crried out under septic conditions. (.) Following the intrvitrel injection, ptients should e monitored for elevtion in introculr pressure nd for endophthlmitis. (.) DSAGE FRMS AND STRENGTHS Non-ioerodle intrvitrel implnt contining.19 mg fluocinolone cetonide in drug delivery system. (3) culr or perioculr infections (.1) Glucom (.) Hypersensitivity (.3) CNTRAINDICATINS WARNINGS AND PRECAUTINS Intrvitrel injections hve een ssocited with endophthlmitis, eye inflmmtion, incresed introculr pressure, nd retinl detchments. Ptients should e monitored following the injection. (5.1) Use of corticosteroids my produce posterior sucpsulr ctrcts, incresed introculr pressure, glucom, nd my enhnce the estlishment of secondry oculr infections due to cteri, fungi, or viruses. (5.) The implnt my migrte into the nterior chmer if the posterior lens cpsule is not intct. (5.3) ADVERSE REACTINS In controlled studies, the most common dverse rections reported were ctrct development nd increses in introculr pressure. (.1) To report SUSPECTED ADVERSE REACTINS, contct Alimer Sciences, Inc. t or FDA t 1 -FDA-1 or See 17 for PATIENT CUNSELING INFRMATIN Revised: 1/1 1 INDICATINS AND USAGE FULL PRESCRIBING INFRMATIN: CNTENTS* DSAGE AND ADMINISTRATIN.1 Generl Dosing Informtion. Administrtion 3 DSAGE FRMS AND STRENGTHS CNTRAINDICATINS.1 culr or Perioculr Infections. Glucom.3 Hypersensitivity 5 WARNINGS AND PRECAUTINS 5.1 Intrvitrel Injection-relted Effects 5. Steroid-relted Effects 5.3 Risk of Implnt Migrtion ADVERSE REACTINS.1 Clinicl Studies Experience. Postmrketing Experience FULL PRESCRIBING INFRMATIN 1 INDICATINS AND USAGE USE IN SPECIFIC PPULATINS.1 Pregnncy.3 Nursing Mothers. Peditric Use.5 Geritric Use 11 DESCRIPTIN 1 CLINICAL PHARMACLGY 1.1 Mechnism of Action 1.3 Phrmcokinetics 13 NNCLINICAL TXICLGY 13.1 Crcinogenesis, Mutgenesis, Impirment of Fertility 1 CLINICAL STUDIES 1 HW SUPPLIED/STRAGE AND HANDLING 17 PATIENT CUNSELING INFRMATIN * Sections or susections omitted from the full prescriing informtion re not listed. (fluocinolone cetonide intrvitrel implnt).19 mg is indicted for the tretment of dietic mculr edem in ptients who hve een previously treted with course of corticosteroids nd did not hve cliniclly significnt rise in introculr pressure. DSAGE AND ADMINISTRATIN.1 Generl Dosing Informtion For ophthlmic intrvitrel injection.. Administrtion The intrvitrel injection procedure should e crried out under septic conditions, which include use of sterile gloves, sterile drpe, sterile cliper, nd sterile eyelid speculum (or equivlent). Adequte nesthesi nd rod-spectrum microicide should e given prior to the injection. The injection procedure for is s follows: 1. The exterior of the try should not e considered sterile. An ssistnt (nonsterile) should remove the try from the crton nd exmine the try nd lid for dmge. If dmged, do not use unit. If cceptle, the ssistnt should peel the lid from the try without touching the interior surfce.. Visully check through the viewing window of the preloded pplictor to ensure tht there is drug implnt inside. 3. Remove the pplictor from the try with sterile gloved hnds touching only the sterile interior try surfce nd pplictor. The protective cp on the needle should not e removed until the ptient is redy to e injected. Prior to injection, the pplictor tip must e kept ove the horizontl plne to ensure tht the implnt is properly positioned within the pplictor.. To reduce the mount of ir dministered with the implnt, the dministrtion procedure requires two steps. Before inserting the needle into the eye, push the pplictor utton down nd slide it to the first stop (t the curved lck mrks longside the utton trck). At the first stop, relese the utton nd it should move to the UP position. If the utton does not rise to the UP position, do not proceed with this unit. 5. ptiml plcement of the implnt is inferior to the optic disc nd posterior to the equtor of the eye. Mesure millimeters inferotemporl from the limus with the id of clipers for point of entry into the scler.. Crefully remove the protective cp from the needle nd inspect the tip to ensure it is not ent. 7. Gently displce the conjunctiv so tht fter withdrwing the needle, the conjunctivl nd sclerl needle entry sites will not lign. Cre should e tken to void contct etween the needle nd the lid mrgin or lshes. Insert the needle through the conjunctiv nd scler. To relese the implnt, while the utton is in the UP position, dvnce the utton y sliding it forwrd to the end of the utton trck nd remove the needle. Note: Ensure tht the utton reches the end of the trck efore removing the needle.. Remove the lid speculum nd perform indirect ophthlmoscopy to verify plcement of the implnt, dequte centrl retinl rtery perfusion nd sence of ny other complictions. Following the injection, ptients should e monitored for elevtion in introculr pressure nd for endophthlmitis. Monitoring my consist of check for perfusion of the optic nerve hed immeditely fter the injection, tonometry within 3 minutes following the injection, nd iomicroscopy etween two nd seven dys following the injection. Ptients should e instructed to report without dely ny symptoms suggestive of endophthlmitis. 3 DSAGE FRMS AND STRENGTHS is non-ioerodle intrvitrel implnt in drug delivery system contining.19 mg fluocinolone cetonide, designed to relese fluocinolone cetonide t n initil rte of.5 μg/dy nd lsting 3 months. CNTRAINDICATINS.1 culr or Perioculr Infections is contrindicted in ptients with ctive or suspected oculr or perioculr infections including most virl disese of the corne nd conjunctiv including ctive epithelil herpes simplex kertitis (dendritic kertitis), vccini, vricell, mycocteril infections nd fungl diseses.. Glucom is contrindicted in ptients with glucom, who hve cup to disc rtios of greter thn...3 Hypersensitivity is contrindicted in ptients with known hypersensitivity to ny components of this product. 5 WARNINGS AND PRECAUTINS 5.1 Intrvitrel Injection-relted Effects Intrvitrel injections, including those with, hve een ssocited with endophthlmitis, eye inflmmtion, incresed introculr pressure, nd retinl detchments. Ptients should e monitored following the intrvitrel injection [see Ptient Counseling Informtion (17)]. 5. Steroid-relted Effects Use of corticosteroids including my produce posterior sucpsulr ctrcts, incresed introculr pressure nd glucom. Use of corticosteroids my enhnce the estlishment of secondry oculr infections due to cteri, fungi, or viruses. Corticosteroids re not recommended to e used in ptients with history of oculr herpes simplex ecuse of the potentil for rectivtion of the virl infection. 5.3 Risk of Implnt Migrtion Ptients in whom the posterior cpsule of the lens is sent or hs ter re t risk of implnt migrtion into the nterior chmer. ADVERSE REACTINS.1 Clinicl Studies Experience Becuse clinicl trils re conducted under widely vrying conditions, dverse rection rtes oserved in the clinicl trils of drug cnnot e directly compred to rtes in the clinicl trils of nother drug nd my not reflect the rtes oserved in prctice. Adverse rections ssocited with ophthlmic steroids including include ctrct formtion nd susequent ctrct surgery, elevted introculr pressure, which my e ssocited with optic nerve dmge, visul cuity nd field defects, secondry oculr infection from pthogens including herpes simplex, nd perfortion of the gloe where there is thinning of the corne or scler. ws studied in two multicenter, rndomized, shm-controlled, msked trils in which ptients with dietic mculr edem were treted with either (n=375) or shm (n=15). Tle 1 summrizes sfety dt ville when the lst suject completed the lst 3 month follow up visit for the two primry trils. In these trils, sujects were eligile for retretment no erlier thn 1 months fter study entry. ver the three yer follow up period, pproximtely 75% of the treted sujects received only one implnt. The most common oculr (study eye) nd non-oculr dverse rections re shown in Tles 1 nd : Tle 1: culr Adverse Rections Reported y 1% of Ptients nd Non-oculr Adverse Rections Reported y 5% of Ptients Adverse Rections (N=375) (N=15) culr Ctrct 1 19/35 (%) 1/11 (5%) Myodesopsi (1%) 17 (9%) Eye pin 57 (15%) 5 (1%) Conjunctivl hemorrhge 5 (13%) 1 (11%) Posterior cpsule opcifiction 35 (9%) (3%) Eye irrittion 3 (%) 11 (%) Vitreous detchment (7%) 1 (7%) Conjunctivitis 1 (%) 5 (3%) Cornel oedem 13 (%) 3 (%) Foreign ody senstion in eyes 1 (3%) (%) Eye pruritus 1 (3%) 3 (%) culr hyperemi 1 (3%) 3 (%) ptic trophy 9 (%) (1%) culr discomfort (%) 1 (1%) Photophoi 7 (%) (1%) Retinl exudtes 7 (%) (%) Anterior chmer cell (%) 1 (1%) Eye dischrge (%) 1 (1%) Non-oculr Anemi (11%) 1 (5%) Hedche 33 (9%) 11 (%) Renl Filure 3 (9%) 1 (5%) Pneumoni (7%) (%) 1 Includes ctrct, ctrct nucler, ctrct sucpsulr, ctrct corticl nd ctrct dietic in ptients who were phkic t seline. Among these ptients, % of sujects vs. 7% of shm-controlled sujects underwent ctrct surgery. 35 of the 375 sujects were phkic t seline; 11 of 15 shmcontrolled sujects were phkic t seline. Incresed introculr Pressure Tle : Summry of Elevted IP Relted Adverse Rections Event (N=375) (N=15) IP elevtion 1 mmhg from Bseline 17 (3%) 1 (1%) IP elevtion 3 mmhg 75 (%) (%) Any IP-lowering mediction 1 (3%) (1%) Any surgicl intervention for elevted introculr pressure 1 (5%) 1 (1%) Men Introculr Pressure (mm Hg) Figure 1: Men IP during the study Ctrcts nd Ctrct Surgery (N=375) (N=15) At seline, 35 of the 375 sujects were phkic; 11 of 15 shmcontrolled sujects were phkic. The incidence of ctrct development in ptients who hd phkic study eye ws higher in the group (%) compred with (5%). The medin time of ctrct eing reported s n dverse event ws pproximtely 1 months in the group nd 19 months in the group. Among these ptients, % of sujects vs. 7% of shm-controlled sujects underwent ctrct surgery, generlly within the first 1 months (Medin 15 for oth group nd for ) of the studies.. Postmrketing Experience The following rections hve een identified during post-mrketing use of in clinicl prctice. Becuse they re reported voluntrily estimtes of frequency cnnot e mde. The rections, which hve een chosen for inclusion due to either their seriousness, frequency of reporting, possile cusl connection to, or comintion of these fctors, include reports of drug dministrtion error nd reports of the drug eing ineffective. USE IN SPECIFIC PPULATINS.1 Pregnncy Pregnncy Ctegory C There re no dequte nd well-controlled studies of in pregnnt women. Animl reproduction studies hve not een conducted with fluocinolone cetonide. Corticosteroids hve een shown to e tertogenic in lortory nimls when dministered systemiclly t reltively low dosge levels. should e used during pregnncy only if the potentil enefit justifies the potentil risk to the fetus..3 Nursing Mothers Systemiclly dministered corticosteroids re present in humn milk nd could suppress growth nd interfere with endogenous corticosteroid production. The systemic concentrtion of fluocinolone cetonide following intrvitrel tretment with is low [see Clinicl Phrmcology (1.3)]. It is not known whether intrvitrel tretment with could result in sufficient systemic sorption to produce detectle quntities in humn milk. Exercise cution when is dministered to nursing womn.. Peditric Use Sfety nd effectiveness of in peditric ptients hve not een estlished..5 Geritric Use No overll differences in sfety or effectiveness hve een oserved etween elderly nd younger ptients. 11 DESCRIPTIN is sterile non-ioerodle intrvitrel implnt contining.19 mg (19 mcg) fluocinolone cetonide in 3-month sustined-relese drug delivery system. is designed to relese fluocinolone cetonide t n initil rte of.5 μg/ dy. is preloded into single-use pplictor to fcilitte injection of the implnt directly into the vitreous. The drug sustnce is synthetic corticosteroid, fluocinolone cetonide. The chemicl nme for fluocinolone cetonide is (α,11β, 1α)-,9-difluoro-11,1- dihydroxy-1,17-[(1-methylethylidene)is-(oxy)]-pregn-1,-diene-3,-dione. Its chemicl structure is: H MW 5.5; moleculr formul C H 3 F F F H

5 Fluocinolone cetonide is white or lmost white, microcrystlline powder, prcticlly insolule in wter, solule in methnol, ethnol, chloroform nd cetone, nd springly solule in ether. Ech consists of light rown 3.5mm x.37mm implnt contining.19 mg of the ctive ingredient fluocinolone cetonide nd the following inctive ingredients: polyimide tue, polyvinyl lcohol, silicone dhesive nd wter for injection. 1 CLINICAL PHARMACLGY 1.1 Mechnism of Action Corticosteroids inhiit inflmmtory responses to vriety of inciting gents. They inhiit edem, firin deposition, cpillry diltion, leukocyte migrtion, cpillry prolifertion, firolst prolifertion, deposition of collgen, nd scr formtion ssocited with inflmmtion. Corticosteroids re thought to ct y inhiition of phospholipse A vi induction of inhiitory proteins collectively clled lipocortins. It is postulted tht these proteins control iosynthesis of potent meditors of inflmmtion such s prostglndins nd leukotrienes y inhiiting relese of the common precursor, rchidonic cid. Archidonic cid is relesed from memrne phospholipids y phospholipse A. 1.3 Phrmcokinetics In humn phrmcokinetic study of, fluocinolone cetonide concentrtions in plsm were elow the lower limit of quntittion of the ssy (1 pg/ml) t ll post-dministrtion time points from Dy 7 through 3 following intrvitrel dministrtion of. mcg/dy or.5 mcg/dy fluocinolone cetonide insert. 13 NNCLINICAL TXICLGY 13.1 Crcinogenesis, Mutgenesis, Impirment of Fertility Long-term niml studies hve not een conducted to determine the crcinogenic potentil or the effect on fertility of. Fluocinolone cetonide ws not genotoxic in vitro in the Ames test (S. typhimurium nd E. coli) nd the mouse lymphom TK ssy, or in vivo in the mouse one mrrow micronucleus ssy. 1 CLINICAL STUDIES The efficcy of ws ssessed in two three-yer, rndomized (:1, ctive: shm), multicenter, doule-msked, prllel-groups studies tht enrolled ptients with dietic mculr edem tht hd previously een treted with lser photocogultion. The primry efficcy endpoint in oth trils ws the proportion of sujects in whom vision hd improved y 15 letters or more from seline fter months of follow-up. Tle 3: Bseline BCVA (Letters) (N=19) Study 1 Study (N=95) (N=1) (N=9) Men (SD) 53 (13) 55 (11) 53 (1) 55 (11) Medin (Rnge) 57 (19-75) 5 (5-9) 5 (-7) 5 (1-) Tle : Visul Acuity outcomes t (All rndomized sujects with LCF) Study utcomes 1 Gin of 15 letters in BCVA Loss of 15 letters in BCVA Men chnge from seline in BCVA (SD) Gin of 15 letters in BCVA Loss of 15 letters in BCVA Men chnge from seline in BCVA (SD) Study 1:, N=19;, N=95 Study :, N=1;, N=9 51 (7%) 1 (15%) (1%) 5 (5%) Estimted Difference (95% CI) 1.1% (.%, 1.%).% (1.%, 15.1%) 3.7 (1.7) 3. (13.1) 1. (-.,.3) 57 (31%) 1 (1%) 13.% (.7%, 3.%) (1%) 9 (1%) 1.% (-5.9%, 9.%) 5. (1.). (15.).1 (1., 1.) Visul cuity outcomes y lens sttus (Phkic or Pseudophkic) t different visits re presented in Figure nd Figure 3. The occurrence of ctrcts impcted visul cuity during the study. Ptients who were pseudophkic t seline chieved greter men BCVA chnge from seline t the study visit. 3 1 Figure : Proportion of sujects with > =15 Letters Improvement from Bseline BCVA in the Study Eye Study 1: Phkic Sujects (N=1) 9.% 1.% (N=1) 9.% 19.7% Study : Phkic Sujects (N=11).% 1.3% (N=) Study 1: Phkic Sujects.%.% (N=1) 3. (1.9). (.9) (N=1) Study : Phkic Sujects Figure 3: Men BCVA Chnge from Bseline 5. (.) 3. (13.7) (N=11) 3. (19.3). (1.1) (N=).9 (17.5) 1. (15.1) Study 1: Pseudophkic Sujects (N=) 1.%.% (N=3) 5.% 17.% Study : Pseudophkic Sujects (N=7) 33.% 1.7% (N=3) Study 1: Pseudophkic Sujects 3.% 1.7% (N=).1 (13.5).9 (1.5) (N=3) Study : Pseudophkic Sujects. (17.) 3.5 (1.1) (N=7). (15.3) -. (1.) (N=3). (19.5) -. (19.1) The BCVA outcomes for the Pseudophkic nd Phkic sugroups from Studies 1 nd t re presented in Tle 5. Tle 5: Visul Acuity outcomes t (Sugroup for pooled dt with LCF) Lens Sttus utcomes Pseudophkic Phkic Gin of 15 Loss of 15 Men chnge from seline in BCVA (SD) Gin of 15 Loss of 15 Men chnge from seline in BCVA (SD) 39 (%) (13%) 7 (5%) 7 (11%) Estimted Difference (95% CI) 15.% (.%,.3%) -5.9% (-1.%,.5%) 7.1 (1.5) 1.5 (17.) 5. (.7, 1.) 9 (9%) (1%) 1 (17%) 7 (%). (.1) Pseudophkic:, N=1;, N= Phkic:, N=3;, N=11 1 HW SUPPLIED/STRAGE AND HANDLING 11.1% (.1%,.1%) 11.% (5.%, 1%) 1. (1.) 1 (-.5,.) (fluocinolone cetonide intrvitrel implnt).19 mg is supplied in sterile single use preloded pplictor with 5-guge needle, pckged in try seled with lid inside crton. NDC Storge: Store t 15-3 C (59 - F). 17 PATIENT CUNSELING INFRMATIN Steroid-relted Effects Advise ptients tht ctrct my occur fter tretment with. If this occurs, dvise ptients tht their vision will decrese, nd they will need n opertion to remove the ctrct nd restore their vision. Advise ptients tht they my develop incresed introculr pressure with tretment, nd the incresed IP my need to e mnged with eye drops, or surgery. Intrvitrel Injection-relted Effects Advise ptients tht in the dys following intrvitrel injection of, ptients re t risk for potentil complictions including in prticulr, ut not limited to, the development of endophthlmitis or elevted introculr pressure. When to Seek Physicin Advice Advise ptients tht if the eye ecomes red, sensitive to light, pinful, or develops chnge in vision, they should seek immedite cre from n ophthlmologist. Driving nd Using Mchines Inform ptients tht they my experience temporry visul lurring fter receiving n intrvitrel injection. Advise ptients not to drive or use mchines until this hs een resolved. Mnufctured for: Alimer Sciences, Inc. 1 Windwrd Prkwy Alphrett, GA 35 Ptented. See: US-ILV-MMM-115