Alcon a publiÃ© il y a quelques jours un communiquÃ© de presse (Source : OSN SuperSite), suite Ã un courrier de la FDA rÃ©clamant des donnÃ©es complÃ©mentaires pour approuver Retaane (acÃ©tate d’anÃ©cortave) en traitement de la DMLA exsudative :
HUENENBERG, Switzerland â€” Alcon has received an approvable letter from the U.S. Food and Drug Administration for Retaane, its anecortave acetate treatment for wet age-related macular degeneration. However, the FDA will require an additional clinical trial before it grants final approval, according to an Alcon press release.
Alcon has no immediate plans to conduct a new study due to the difficulty of recruiting patients in light of other treatments currently available for wet AMD, the release said.
Plus que la difficultÃ© de recrutement, je me demande si le frein principal Ã poursuivre le dÃ©veloppement n’est pas plutÃ´t le fait qu’il n’ait malheureusement pas Ã©tÃ© possible de dÃ©montrer (statistiquement) la non-infÃ©rioritÃ© de Retaane par rapport Ã la photothÃ©rapie dynamique avec Visudyne (Slakter JS & al. Anecortave acetate (15 milligrams) versus photodynamic therapy for treatment of subfoveal neovascularization in age-related macular degeneration. Ophthalmology. 2006 Jan;113(1):3-13) : difficile dans ces conditions de concurrencer maintenant les anti-VEGF !
Par contre, il aurait peut-Ãªtre Ã©tÃ© intÃ©ressant de le tester en relai des traitements anti-VEGF ?
However, the company continues to believe that Retaane (15 mg anecortave acetate suspension) could play a role in the treatment of wet AMD. Alcon plans to continue supporting the Anecortave Acetate Risk-Reduction Trial, which is studying the ability of Retaane to reduce the risk of the progression from the dry form of AMD to the wet form. This trial, which is fully enrolled with more than 2,500 patients, is expected to be completed within 3 years, according to the release.
In addition, Alcon is conducting clinical studies of anecortave acetate, the active ingredient in Retaane, for the treatment of glaucoma.
Effectivement, deux Ã©tudes sont en cours pour essayer de convertir ce traitement de la DMLA en anti-glaucomateux :
- Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation
- Safety and Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
Retaane suspension remains commercially available in several countries outside of the United States.
VoilÃ ce que cela donne en Suisse d’aprÃ¨s une publication rÃ©cente… (Hayek S & al. First clinical experience with anecortave acetate (Retaane). Klin Monatsbl Augenheilkd. 2007 Apr;224(4):279-81) :
BACKGROUND: Anecortave acetate is an angiostatic cortisene which is injected as a posterior juxtascleral depot and has been shown to be effective in the treatment of exudative age-related macular degeneration (AMD). The compound is not yet approved in Switzerland but can be used as « compassionate use » in individual cases.
PATIENTS AND METHODS: An uncontrolled case series with standardised documentation of ETDRS visual acuity, near acuity, need for magnification and fluorescein angiography was performed.
RESULTS: 22 eyes of 19 patients (8 male, 11 female, average age 78.8 years) were treated with a posterior juxtascleral depot injection (PJD) of 15 mg anecortave acetate. The mean change in visual acuity after 3 months in eyes treated with anecortave acetate was -2.6 ETDRS letters corresponding to 0.52 Snellen lines. 3/20 eyes gained more than 1 line. 11/20 eyes showed stable visual acuity (+/- 1 Snellen line, +/- 5 ETDRS letters). 5/20 eyes developed moderate vision loss (one to two Snellen lines, 6-10 ETDRS letters). 1/20 lost 18 ETDRS letters (> 3 Snellen lines). There were no moderate or severe adverse events.
CONCLUSIONS: A PJD of 15 mg anecortave acetate is safe and well tolerated. In eyes with occult CNV without recent progression or with residual neovascular activity after photodynamic therapy anecortave acetate may be an alternative therapeutic option before considering intravitreal anti-VEGF agents due to the much less invasive character and lower risk profile.
On semble effectivement bien loin des rÃ©sultats des anti-VEGF…