VISUDYNE - VISUDYNE - CT 8965 - Version anglaise
Description
Présentation VISUDYNE 15 mg, poudre pour solution pour perfusion 1 flacon(s) en verre de 15 mg - Code CIP : 3553076 Mis en ligne le 02 avr. 2013 Substance active (DCI) vertéporfine Code ATC S01LA01 Laboratoire / fabricant NOVARTIS PHARMA S.A.S. VISUDYNE 15 mg, poudre pour solution pour perfusion 1 flacon(s) en verre de 15 mg - Code CIP : 3553076 Mis en ligne le 02 avr. 2013
Informations
| Publié par | haute-autorite-sante-maladies-oeil |
| Publié le | 17 octobre 2012 |
| Nombre de lectures | 34 |
| Licence : |
En savoir + Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
|
| Langue | English |
Extrait
The legally binding text is the original French version
TRANSPARENCY COMMITTEE
OPINION 17 October 2012 Examination of the dossier for a medicinal product included for a 5-year period starting on 22 February 2007 (Official Gazette of 3 October 2007) VISUDYNE 15 mg, powder for solution for infusion Vial of 15 mg (CIP code: 355 307-6) Applicant: NOVARTIS PHARMA S.A.S. Verteporfin ATC code: S01LA01 List I Medicine requiring special monitoring during treatment. Prescription restricted to ophthalmology specialists. Exception drug status Date of European Marketing Authorisation: 27 July 2000 Date of main Marketing Authorisation amendments: 20 March 2001: Extension of indication: “treatment of adults with subfoveal choroidal neovascularisation secondary to pathological myopia 22 August 2002: Extension of indication: “treatment of patients with age-related macular degeneration with occult subfoveal choroidal neovascularisation with signs of recent progression or with active disease. 23 April 2008 : Rescindment of Marketing Authorisation for the indication : “treatment of patients with age-related macular degeneration with occult subfoveal choroidal neovascularisation with signs of recent progression or with active disease. Reason for request: Renewal of inclusion on the list of medicines refundable by National Health Insurance. Medical, Economic and Public Health Assessment Division
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CHARACTERISTICS OF THE MEDICINAL PRODUCT
1.1. Active ingredient Verteporfin
1.2. Indications “VISUDYNE is indicated for the treatment of - adults with exsudative (wet) age-related macular degeneration (AMD) with predominantly visible subfoveal choroidal neovascularisation (CNV) or - adults with subfoveal choroidal neovascularisation secondary to pathological myopia
1.3. Dosage “VISUDYNE should be administered only by ophthalmologists experienced in the management of patients with age-related macular degeneration or with pathological myopia. VISUDYNE photodynamic therapy (PDT) is a two-step process: The first step is a 10-minute intravenous infusion of VISUDYNE at a dose of 6 mg/m2body surface area, diluted in 30 ml infusion solution). The second step is the light activation of VISUDYNE at 15 minutes after the start of the infusion. Patients should be re-evaluated every 3 months. In the event of recurrence, VISUDYNE therapy may be given up to 4 times per year.
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REMINDER OF THE COMMITTEE’S OPINIONS AND CONDITIONS OF INCLUSION
Committee Opinion of 11 October 2000 Inclusion for the “Treatment of age-related macular degeneration in patients with predominantly visible subfoveal colloidal neovascularisation The actual benefit of VISUDYNE in this indication is substantial. The improvement in actual benefit is substantial (level 1). Committee Opinion of 20 November 2002 Inclusion for the extension to indication: “treatment of patients with subfoveal choroidal neovascularisation secondary to pathological myopia The actual benefit of VISUDYNE in the extension to the indication is substantial. The improvement in actual benefit is substantial (level 1).
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Committee Opinion of 23 July 2003 Registered for the indication: “treatment of patients with age-related macular degeneration with occult subfoveal choroidal neovascularisation with signs of recent progression or with active disease. The actual benefit is substantial. The level I IAB is confirmed in the extension of the indication for the treatment of patients with age-related macular degeneration and occult choroidal subfoveal neovascularisation with signs of recent progression or with active disease. In the absence of sufficient data the Committee cannot make a statement about the forms of disease associated with detachment of the pigment epithelium or retino-choroidal anastomoses. The investigations used to establish the diagnosis must include fluorescein angiography which must be supplemented by indocyanine green angiography. The ophthalmologist should keep the documentation of the assorted findings justifying starting treatment. Committee Opinion of 17 December 2003 (supplement to the opinion of 23 July 2003) New review of the indication: “treatment of patients with age-related macular degeneration with occult subfoveal choroidal neovascularisation with signs of recent progression or with active disease. The AB is substantial in occult subfoveal AMD with signs of recent progression or during disease (except in pigmented epithelial detachment and/or retino-choroidal anastomoses. The actual benefit is insufficient in patients with detachment of the pigment epithelium. The actual benefit is low in patients with early retino-choroidal anastomoses without detachment of the pigment epithelium. The actual benefit is insufficient in patients with non-incipient retino-choroidal anastomoses (with scaring fibrosis). VISUDYNE offers a modest improvement (level III) in terms of efficacy compared to the usual management in forms of disease associated with early anastomoses (no scarring fibrosis) without detachment of the pigment epithelium. Committee Opinion of 29 November 2006 Renewal of inclusion Treatment of patients suffering from age-related macular degeneration with predominantly visible subfoveal choroidal neovascularisation: Age-related macular degeneration (AMD) is the leading cause of blindness in France in patients over 50 years old. The severe forms of AMD which are responsible for the largest number of cases of severe reduction in visual acuity are the exsudative or neovascular forms. This proprietary medicinal product is a curative therapy for the consequences of the disease. The efficacy/adverse effects ratio is moderate. This medicinal product is a first-line therapy. There is an alternative medical treatment: pegaptanib (MACUGEN). The actual benefit of VISUDYNE is substantial. Treatment of patients with subfoveal choroidal neovascularisation secondary to pathological myopia: The neovascular complications of pathological myopia are amongst the most sudden to appear and can cause severe disability due to loss of central vision. This disability is particularly severe as it often occurs in patients of working age. This proprietary medicinal product is a curative therapy for the consequences of the disease.
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The efficacy/adverse effects ratio is modest. This medicinal product is a first-line therapy. There is no treatment alternative in this indication. The actual benefit of VISUDYNE is substantial. Committee Opinion of 12 September 200 7 Request for removal of the indication for “occult subfoveal CNV following rescindment of the MA in this indication The Committee approves removal from the list of medicines refundable by National Health Insurance and the list of medicines approved for use by hospitals and various public services in the indication: “treatment of patients with age-related macular degeneration with occult subfoveal choroidal neovascularisation with signs of recent progression or with active disease. The Committee notes the new wording of the indications retained within the Marketing Authorisation.
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3.1. S S01 S01L S01LA S01LA
SIMILAR MEDICINAL PRODUCTS
ATC Classification (2012) Sensory organs Ophthalmologicals Medicines for ocular vascular problems anti-neovascular medicines 01 Verteporfin
3.2. Medicines in the same therapeutic category Lack of medical or non-medical therapeutic alternative in the same pharmaco-therapeutic class.
3.3. Medicines with a similar therapeutic aim The medicines used to tread AMD are those in the anti-VEGF class: pegaptanib (MACUGEN) and ranibizumab (LUCENTIS).
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UPDATE ON THE DATA AVAILABLE SINCE THE PREVIOUS OPINION
4.1. Efficacy The company has submitted three new clinical studies which have assessed the efficacy of photodynamic therapy (PDT) with verteporfin combined with ranibizumab compared to ranibizumab alone or verteporfin alone in the treatment of neovascular AMD (FOCUS, DENALI, MONT-BLANC, and RADICAL). The FOCUS, MONT-BLANC and RADICAL studies are not described here as these are phase II studies. DENALI study1: verteporfin + ranibizumab compared to ranibizumab This was a double-blind, randomised phase IIIb study lasting 24 months (which was subsequently reduced to 12 months following the results of the phase II MONT-BLANC study which showed the combination of verteporfin + ranibizumab to be non-inferior to ranibizumab alone) in 321 patients with AMD and visible or occult subfoveal CNV. The primary objective of the study was to demonstrate the non-inferiority of at least one of the treatments in a combination of ranibizumab + PDT with verteporfin compared to ranibizumab monotherapy in terms of the mean change in MAVC at 12 months compared to the baseline value. The non-inferiority threshold was set at 7 letters (ETDRS). The patients were divided into three groups: - ranibizumab 0.5 mg + PDT with verteporfin therapy with standard fluency (50 J/cm2) (n = 104) - ranibizumab 0.5 mg + PDT with verteporfin therapy with reduced fluency (25 J/cm2) (n = 105) - ranibizumab 0.5 mg as monotherapy (n = 112) In the combination groups the patients were treated with verteporfin on D0 and with three monthly intravitreal injections of 0.5 mg of ranibizumab. The decision to re-treat with verteporfin or ranibizumab was taken from 3 months by the investigator in the monthly review visits depending on pre-specified criteria based on the OCT, ophthalmological examination, measurement of visual acuity and fluorescein angiography. Patients in the ranibizumab group were given monthly intravitreal injections throughout the study period and had simulated PDT. Results: Of the 321 patients randomised, 286 (89.1%) completed the study. The results were analysed on the ITT population. Mean corrected visual acuity was 54 letters (ETDRS) before treatment. Depending on the groups, 53 to 58% of patients had occult or minor visible lesions. Visual acuity improved by +8.1 letters at 12 months with ranibizumab, by +5.3 letters with the PDT with standard fluency combination and by +4.4 letters with the PDT with reduced fluency combination. Non-inferiority was not demonstrated.
4.2. Adverse effects The company submitted international pharmacovigilance data covering the period from 16 December 2004 to 31 December 2007 and French data covering the period from 1st April 2005 to 31 December 2010.
1Unpublished Novartis data (clinical study report).
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Following an analysis of these data, the "Adverse effects" section of the SPC was amended by adding the following adverse effects: - myocardial infarction, occasionally within 48 hours following the infusion, particularly in patients with a cardiovascular history; - retinal pigment epithelium tear; The section "Pregnancy and lactation" was amended as follows: "Lactation: verteporfin and its diacid metabolite are excreted in small amounts in human breast milk. As a result, VISUDYNE must not be given to women who are breastfeeding or alternatively breastfeeding must be stopped for 48 hours after administration. " The pharmacovigilance data for the period from 1st January 2008 to 31 December 2011 have not shown any new safety signal justifying a change in the SPC. However, a number of adverse events (pancreatic and hepatobiliary disorders, joint and labyrinth problems, cardiovascular events, chest pain, reduced visual acuity, macular and retinal oedema, increased intra-ocular pressure) occurring concomitantly with the use of VISUDYNE must be monitored.
4.3. Conclusion The new efficacy and safety data do not change the efficacy/adverse effects ratio for VISUDYNE.
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MEDICINAL PRODUCT USAGE DATA
Observational study in pathological myopia: VISEOM study
In 2002, the TC requested that a post-Inclusion study be carried out on VISUDYNE in pathological myopia. The request was worded as follows: "Patient follow up must be set up. This must include change in visual acuity, time to retreatment and number of re-treatments stratified by patient age (over and under 50 years old). " In order to respond to this request the company set up an observational study, the VISEOM study, which was carried out between June 2007 and November 2009. The objectives of this study were to describe the conditions of use of VISUDYNE and monitor clinical change (visual acuity) in patients treated at 24 months. Inclusion data ·
The 34 centres which agreed to take part in the study were mostly private clinics (35.3%) and self-employed medical consulting rooms (35.3%). More than half of these carried out over 200 PDT annually ("substantial activity"), compared to 34% on a national level. A total of 20 centres were active and included 682 patients,including 62 who met the inclusion criteria. 3 Average patient age was 55 years old (27.4% were under 50 years old) and 82.3% were women. The diagnosis of the CNV in the eye being studied had been made an average of 4.6 months previously. The disease was unilateral in 95.2% of cases (only three patients had bilateral disease). Fifty-seven (91.9%) of the patients included had visible CNV, four had occult CNV (6.5%) and one had CNV for which the type had not been established.
2 The protocol planned for 38 centres and 224 patients to be included, i.e. 112 patients per age band under and ver 50 ears old. 3ae lf-voxuatdaj ey hs thed acludxe erew stneitapx Si y ow nol satimit desuo ovbfl eaenvosaucalirasiton (the indicati CNV due to pathological myopia).
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There were no differences in sociodemographic features by age band (+/- 50 years old). Thirty-nine of the 62 patients included were receiving their first treatments (62.9%), i.e. they had never been treated for their CNV and 23 had previously been treated (37.1%: previous laser, anti-VEGF, corticosteroid or VISUDYNE treatment, etc.). Forty-two were VISUDYNE treatment naive (67.7%). Of the 20 patients already treated with VISUDYNE, 2/3 had been given a single injection. The mean number of VISUDYNE treatments was 1.7 per patient. The criteria for starting treatment were as follows: visual acuity≥2.5 and spot diameter < 5400 µm, and 57.1% of the treatment naive patients and 59.0% of the patients already treated had not responded. · retreatments VISUDYNE 34% of the patients in the study were re-treated with PDT using VISUDYNE at least once during the 12 month follow-up period: 11 patients were retreated once (20.8% of patients), 6 twice (11.3%) and 1 was retreated three times. A total of 22.2% of patients were treated with a period of less than 3 months between the VISUDYNE injections, 55.6% between 3 and 6 months, 16.7% between 6 and 9 months and 5.6% between 9 and 12 months. · Concomitant treatments During the follow-up period, 16 patients (30.2% of the 53 patients in the per protocol population) were treated with an anti-VEGF (of which 13 with ranibizumab, 2 with bevacizumab and 1 with pegaptanib): 10 patients were not treated with anti-VEGF alone and 6 were also treated with VISUDYNE. · Change in distance visual acuity (pure ETDRS and converted Monoyer ) The change in distant visual acuity measured by ETDRS or converted Monoyer scale was known for 53 patients at 12 months (84.1%). Mean distance visual acuity at inclusion in these 53 patients was 41.1 letters (± 22.2) with a median of 48 letters. The mean at 1 year was 51.7 (± 19.2). A mean statistically significant gain of 10.6 letters (+/- 22.3) (median gain 7 letters) was found between inclusion and the 12 month visit. However, mean distance visual acuity remained stable during this period in the 20 patients whose visual acuity was measured by the ETDRS scale, falling from 46.1 (+/- 17.4) to 44.8 (+/- 22.5) letters with a median falling from 51 letters at inclusion to 39 letters at 12 months. The opposite change was found in the 34 patients whose visual acuity was measured with the Monoyer scale. Average distance acuity increased from 0.147 (+/- 0.332) to 0.239 (+/- 0.424) with median values of 0.200 to 0.300 (mean gain of 2.114 +/- 3.618 and median gain of 1.717).
The results must be interpreted with caution in all of these cases as the confidence intervals were very broad because of the small number of subjects assessed. Results in terms of response to treatment at 1 year varied depending on the allocation method used for missing data:4 proportion of patients who responded to treatment ranged from 69.4% (patients the lost to follow-up and missing data points being treated as failures) to 81.1% (no allocation). There was no change in visual acuity by patient age (over or under 50 years old).
4 Different allocation methods for the patients lost to follow-up were used:4 using the median value, allocation allocation using the poorest value, deeming patients lost to follow-up as being treatment failures, depending on the wishes of the ISPEP group
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Conclusion the conditions of use: On o patients treated with VISUDYNE had all of the investigations required Overall, before starting treatment within the recommended time intervals; o On38.1% of the treatment-naive patients and 35.9% of the other hand, only patients previously treated met two of the criteria for starting treatment in the treatment information form (TIF):5visual acuity≥2.5/10 and spot diameter < 5400 µm; o dosage used and Theretreatment times were consistent with the TIF guidelines. On the change in visual acuity: o a statistically significant mean gain of 10.6 letters (+/- 22.3) (median gain 7 letters) was found between inclusion and the 12 month visit. Depending on the allocation method for patients lost to follow-up, the responder rate at 1 year ranged from 69.4% to 81%. These results are consistent with those from the pivotal study (71.6% responders in the VISUDYNE arm at 1 year). ovisual acuity, however, cannot be attributed to VISUDYNE The impact on treatment alone as 30% of patients were given concomitant treatment, particularly with an anti-VEGF. Further investigations were requested on this point although no conclusion could be drawn. oby patient age (+/- 50 years) showed no difference in terms of analysis The change in the visual acuity of patients who were treated (although a power problem because of the small numbers in the under 50 year old age band cannot be excluded). Observational study in AMD: OVP study The CEPS requested a post-Inclusion study on the proprietary medicinal product VISUDYNE in 2001 in AMD with predominantly visible or occult subfoveal CNV. In order to respond to this request the company set up an observational study, the OPV study which was carried out between 2004 and 2008 with ophthalmologists approved to perform PDT practising either in self-employed or public practice in mainland France. Patient follow-up was set at 2 years. The objective of the study was to describe the conditions of use of VISUDYNE and monitor the clinical outcome in patients who were treated. The primary efficacy endpoint was retreatment with VISUDYNE (defined as the number of retreatments, time before the first treatment and reasons for retreatment with VISUDYNE). The secondary endpoints were change in visual acuity (measurement of VA at 12 and 24 months), time before VA fell and before investigations, number of permanent treatment drop-outs, patients who were lost to follow up and safety parameters (adverse events (AE), including serious AE and deaths). Main results · Data at inclusion Thirty-nine ophthalmologists were active in this study and included 473 patients, 438 of whom were used in the analysis.6
5 The neovascular lesions in patients with a diagnosis of CNV due to pathological myopia had to be subfoveal, visible or occult, with a surface area of≥of the total lesion, the largest linear diameter of which had to be50% , and visual acuit had 2.5/10. 640 5µm0 < for 22 patien che T oper esasmrof try eotb ≥ts were never received, 1 patient was excluded as the patient had not received an injection of VISUDYNE at inclusion and 12 additional patients were excluded from the analyses (7 because their distance visual acuity had not been measured, 3 because the site of the neovascularisation was unknown, 1 because the patient had extra-foveal CNV and 1 because no visual acuity or site of the CNV were available).
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The diagnosis of AMD at inclusion had been made an average of 9 months previously (median 3 months) and almost all of the cases were the exsudative type of disease (98.2%). The contralateral eye was also affected by AMD in 58.3% of patients (n = 254). Before inclusion, 30.7% of the patients had been treated with VISUDYNE in the contralateral eye with an average of two injections. 22.0% had been treated with another medicinal product and an 11.0% with laser (some of these different treatment methods were used at the same time). A large proportion of patients (43.7%) had not received any treatment. 160 patients within the cohort had already been treated with VISUDYNE (36.5%) for the eye being studied and 278 (63.5%) were VISUDYNE treatment naive. VISUDYNE was prescribed for AMD with predominantly visible (n = 202, i.e. 46.1% of cases) or active occult (n = 139, i.e. 31.7% of cases) subfoveal choroidal neovascularisation. This is consistent with the Marketing Authorisation indications refundable by the National Insurance when the study was performed in 77.8% of cases, in 21.7% of cases for a mixed form of AMD and 0.5% for a stable occult form of AMD 91.1% of patients had subfoveal AMD (n = 399) and fewer had juxta-foveal disease (8.9%). The juxta-foveal form of the disease is not one of the indications in the Marketing Authorisation. Mean visual acuity at inclusion was 43 letters (± 18.7) in treatment-naive patients and 37 letters (± 18.2) in previously treated patients (p = 0.002). Visual acuity was > 5/10ths in 4.7% of treatment-naive patients which was in contrast to the TIF guidelines.7 Fluorescein angiography was performed in 97.7% of cases. In the occult forms of AMD, 76.9% of the patients who had never been treated with VISUDYNE had indocyanine green angiography. These results are consistent with the TIF guidelines which applied at the time. On fluorescein angiography, 245 patients (61.4%) had predominantly visible subfoveal neovascularisation and 38.6% had occult disease. The average volume injected at inclusion was 5.2 (± 0.58) mg/m2 surface area (the body dose stated in the TIF was 6 mg/m2). 321 of the 438 patients included in the analysis (73%) had a follow-up visit at 1 year and 287 (65.5%) had a follow-up visit at 2 years.
· VISUDYNE retreatments 287 patients (65.5%) were retreated after inclusion in the study, mostly once (52.3%) or twice (26.8%). The main reason for retreatment was diffusion of the lesions on angiography (76.4% of all visits with the retreatment regardless of date of onset), followed by extension of the lesion (33.9%) and a fall in visual acuity (28.9%). The average time between retreatments was approximately 5 months and in those patients who were retreated the time to treatment was at least 3 months in 79.4% of patients, consistent with the TIF guidelines. Multi-variate modelling was used to examine predictive factors for retreatment. The following factors were found to be related to retreatment with VISUDYNE: - type of lesion: suffering from a visible lesion compared to an occult lesion - past cardiovascular history - stable or improved VA compared to marked improvement or deterioration.
· Concomitant treatments 9.4% of patients (n=41) were treated at least once with corticosteroids or anti-VEGFs during the follow-up: these were mostly patients who had previously been treated as opposed to treatment-naive patients (13.8% compared to 6.8%, p = 0.017). 28% of patients had another concomitant treatment, mostly carotenoid-rich food supplements. 7in treatment-naive patients whose corrected visual acuity is betweenVISUDYNE treatment must only be started 1/10th and 5/10ths inclusive.
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· Change in distance visual acuity (pure ETDRS and converted Monoyer ) The change in distance visual acuity was known in 288 patients at 12 months (65.8%) and in 252 patients at 24 months (57.5%). To recall, mean distance visual acuity at inclusion was 43 letters (± 18.7) in treatment-naive patients and 37 letters (± 18.2) in previously treated patients (p = 0.002). Corresponding figures in treatment-naive patients were 39 (± 18.2) at 1 year and 36 (± 16.9) at 2 years, compared to 34 (± 17.4) at 1 year and 35 (± 17.1) at 2 years in previously treated patients. The fall in distance visual acuity was significant in the treatment-naive patients at 12 and 24 months compared to inclusion (p < 0.001) and was not significant in the previously treated patients. Considering four major categories8(without allocation of missing values): -In treatment-naive patients: 27.2% of patients (n = 46) failed treatment at 2 years (a loss of more than 15 letters), 33.1% (n = 56) were stable (a loss of between 0 and 15 letters) and 27.2% (n = 46) improved. -failed treatment at 2 years (a the previously treated patients: 16.0% of patients (n = 26) In loss of more than 15 letters), 46.9% (n = 76) were stable (a loss of between 0 and 15 letters) and 22.8% (n = 37) improved. The fall in visual acuity was more pronounced in patients with occult CNV. Results in terms of treatment response after follow-up of the total population for 2 years varied depending on the allocation method used for missing values:9 the patient responder rate ranged from 43.2% (treating patients lost to follow-up and missing data points as failures) to 71.1% (allocating using the median) and the percentage of patients who deteriorated ranged from 22.0% to 56.8%. · Adverse effects 46 of the 438 patients studied (10.5%) had at least 1 adverse event (AE), including 38 with at least 1 serious AE (8.7% of the cohort). The 41 serious AEs (SAE) reported, including 15 deaths, mostly involved visual disturbance (21.9% of SAEs); vascular problems (7.3%), including three pulmonary embolisms; fractures (12.1%) and 11 other SAEs including 3 cancers or worsening of cancer. A single case was declared as being related to VISUDYNE. This was a TIA with transient loss of vision in the treated eye for 48 hours after the VISUDYNE injection. The treatment was stopped permanently in this patient. Conclusion Marketing Authorisation for VISUDYNE in AMD was observed in this study. The The dosage was observed throughout as was the retreatment time, observing the period of 3 months between two injections in almost 80% of patients (as defined in the TIF). period. The fall was significant at 12 and visual acuity fell during the follow-up Distance 24 months compared to inclusion in treatment naive patients (p < 0.001) and was not significant in previously treated patients. In terms of responders, the responder rate at 2 years in the whole population was known for almost 60% of patients and varied depending on the allocation method for missing data points from 43.2% to 71.1%. These results are consistent with the results of the pivotal clinical study in which the responder rate at 2 years was 59% in patients treated with VISUDYNE compared to 31% in patients treated with placebo.
8Definitions used: - = a loss of more than 15 letters failure - = a loss of between 0 and 15 letters by the ETDRS scale. stable - = a gain of between 0 and 15 letters improvement -a gain of more than 15 letters. marked improvement = 9Different allocation methods for missing data points (MD) were used: allocating using the median value, allocating using the poorest value and treating MD as treatment failures, at the request of the ISPEP group.
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TRANSPARENCY COMMITTEE CONCLUSIONS
6.1. Re-assessment of actual benefit Treatment of patients suffering from age-related macular degeneration with predominantly visible subfoveal choroidal neovascularisation: Age-related macular degeneration (AMD) is the leading cause of blindness in France in patients over 50 years old. The severe forms of AMD which are responsible for the largest number of cases of severe reduction in visual acuity are the exsudative or neovascular forms. This proprietary medicinal product is a curative treatment for the consequences of the disease. The efficacy/adverse effects ratio is moderate. This medicinal product is a second-line therapy. Alternative medicinal products exist. The actual benefit of VISUDYNE in this indication is substantial. Treatment of patients with subfoveal choroidal neovascularisation due to pathological myopia: The neovascular complications of pathological myopia are amongst the most sudden to appear and can cause severe disability due to loss of central vision. This disability is particularly severe as it often occurs in patients of working age. This proprietary medicinal product is a curative treatment for the consequences of the disease. The efficacy/adverse effects ratio is modest. This medicinal product is a first-line therapy. There is no treatment alternative in this indication. The actual benefit of VISUDYNE in this indication is substantial.
6.2. Therapeutic use 6.2.1. Exsudative AM
D According to the latest HAS guidelines (June 2012) on the management of AMD,10 intravitreal anti-VEGF treatment should be started as early as possible (< 10 days) after the diagnosis of exsudative AMD with subfoveal choroidal neovascularisation is established, regardless of the initial level of visual acuity. PDT with verteporfin (VISUDYNE) is no longer the first-line treatment for exsudative AMD with predominantly visible subfoveal choroidal neovascularisation. It can be used in situations where anti-VEGF are contraindicated or a patient does not respond to anti-VEGF and in some clinical forms of AMD in combination with anti-VEGF (for example polypoidal vasculopathy). VISUDYNE is no longer indicated in exsudative AMD with occult choroidal neovascularisation. The two anti-VEGFs which have Marketing Authorisation in France for the indication "treatment of the neovascular form (wet, exsudative) of AMD" are pegaptanib (MACUGEN)
10 Age-related macular degeneration: diagnostic and therapeutic management. HAS (June 2012). http://www.has-sante.fr/portail/jcms/c_1311607/diagnostic-et-prise-en-charge-de-la-dmla
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