Pendant ce temps lÃ , signalons qu’une premiÃ¨re prostaglandine non conservÃ©e vient d’Ãªtre approuvÃ©e dans certains pays europÃ©ens… et que l’European Glaucoma Society a dÃ©voilÃ© Ã l’occasion de son dernier congrÃ¨s (dÃ©but juin) la nouvelle Ã©dition des « Terminology and Guidelines for Glaucoma », disponible en tÃ©lÃ©chargement sur son site internet.
Il y a quelques jours, le laboratoire Allergan annonÃ§ait son souhait d’Ã©largir les indications du bimatoprost Ã … la stimulation de la pousse des cils !
Ou comment transformer l’effet indÃ©sirable d’un mÃ©dicament en produit cosmÃ©tique…
Contrairement Ã d’autres laboratoires en ce moment, cette stratÃ©gie permettra peut-Ãªtre en outre Ã Allergan d’apprÃ©hender avec sÃ©rÃ©nitÃ© l’avenir et l’arrivÃ©e de mÃ©dicaments gÃ©nÃ©riques !
Cependant, des fabriquants de cosmÃ©tiques y avaient dÃ©jÃ pensÃ© (voir par exemple : « Age Intervention Eyelash Conditioner » (Jan Marini Skin Research) ou « RevitaLash » (Athena Cosmetics Corporation), dÃ©jÃ sur le marchÃ©)… ce qui n’Ã©tait justement pas du goÃ»t du laboratoire, si l’on en croit Ophthalmology Times Europe (janvier 2008)
OÃ¹ l’on reparle de traitements que l’on aurait pu croire Ã l’abandon…
- En l’absence de rÃ©sultats d’Ã©tudes cliniques depuis 2004, l’avenir de la iontophorÃ¨se, dont le principe consiste Ã faciliter la pÃ©nÃ©tration intrasclÃ©rale de molÃ©cules Ã l’aide d’un courant Ã©lectrique, Ã©tait incertain. Or, je l’ai dÃ©jÃ Ã©voquÃ© Ã plusieurs reprises (voir aussi une revue de la littÃ©rature en franÃ§ais sur le sujet dans le JFO de dÃ©cembre 2007), un des dÃ©fis pour les annÃ©es Ã venir sera certainement d’amÃ©liorer les systÃ¨mes de dÃ©livrance de mÃ©dicaments dans l’Å“il, afin par exemple de limiter le recours aux injections intra-vitrÃ©ennes rÃ©pÃ©tÃ©es : la iontophorÃ¨se pourrait constituer une des pistes.
EyeGate vient d’annoncer avoir finalisÃ© un nouveau tour de financement, qui devrait donc permettre de dÃ©buter deux Ã©tudes de phase II (uvÃ©ite et oeil sec) courant 2008… A suivre !
EyeGate Pharma Secures $15M in Series C Venture Funding
WALTHAM, MA–(HSMN NewsFeed)–Mar 12, 2008 — EyeGate Pharma, a privately held, specialty pharmaceutical company using iontophoresis technology to safely and non-invasively deliver therapeutics into the front and back of the eye for treating serious ocular diseases, today announced that the company has secured $15 million in a Series C venture financing round. […]
With this venture financing, EyeGate will enter into two Phase II clinical studies utilizing the EyeGate II Delivery System and a proprietary formulation of a corticosteroid. In the first half of 2008 we will initiate a Phase II trial in severe uveitis, and in the second half of the year we will initiate a Phase II trial in dry eye.[…]
About EyeGate Pharma
EyeGate Pharma was founded in 1999 with technology licensed from Bascom Palmer Eye Institute at the University of Miami. EyeGate’s transscleral (across the sclera, or white protective outer membrane of the eye) iontophoresis delivery platform, the EyeGateÂ® II Delivery System, was developed to safely deliver a wide range of therapeutics to both the anterior (front) and posterior (back) chambers of the eye. An 89-patient clinical study, using the company’s first-generation delivery device, demonstrated significant decreases in inflammatory markers and concurrent increases in visual acuity. A typical application takes less than five minutes and has been shown to be extremely well tolerated in patients suffering from severe uveitis and other inflammatory ocular diseases.
- Alors que l’Anecortave en traitement curatif de la DMLA exsudative ne trouvera probablement jamais sa place dans notre arsenal thÃ©rapeutique, Alcon a prÃ©sentÃ© au cours du dernier congrÃ¨s annuel de l’American Glaucoma Society les rÃ©sultats d’une Ã©tude du dÃ©pot juxta-sclÃ©ral d’anecortave en traitement du glaucome chronique Ã angle ouvert : les deux doses testÃ©es (0.25ml ou 0.5ml soit 7.5 ou 15 mg), injectÃ©es au maximum tous les mois et demi, ont permis d’observer une rÃ©duction significative de la pression intra-oculaire Ã 3 mois, avec une bonne tolÃ©rance…
Alcon Presents Clinical Trial Data On Anecortave Acetate For Glaucoma
Article Date: 10 Mar 2008 – 1:00 PDT
Alcon, Inc. (NYSE: ACL) released the primary efficacy and safety results of the second controlled proof of concept clinical study of anecortave acetate administered as an anterior juxtascleral depot in the sub-Tenon’s space to reduce intraocular pressure in patients with open-angle glaucoma. These initial data were presented at a clinical investigator’s meeting held in association with the annual meeting of the American Glaucoma Society in Washington, DC.
In this safety and efficacy study, 89 patients were randomly assigned to one of three arms: 7.5mg of anecortave acetate dosed with 0.25 mL of 30 mg/mL suspension, 15mg of anecortave acetate dosed with 0.5 mL of 30mg/mL suspension or 0.5 mL of vehicle. Prior to enrolling in the study, all patients had been diagnosed with open-angle glaucoma, had confirmed visual field changes and had off-therapy intraocular pressures (IOP) between 24 mmHg and 36 mmHg. One injection of drug or vehicle was administered to each patient and intraocular pressures were assessed at two weeks, six weeks and at month three, with month three predefined as the visit for primary efficacy. The study design also allowed for a patient to be retreated if more than 42 days had passed since the last administration of anecortave acetate and the patient’s intraocular pressure exceeded 18 mmHg in two consecutive visits scheduled one week apart. The study will continue with clinical assessments at six-week intervals, potentially through month twenty four. The presented results are based on the intent to treat data set of all 89 patients.
As explained during the presentation, the primary conclusion was that both the 7.5 mg and 15 mg doses of anecortave acetate demonstrated statistically significant lower mean IOP than vehicle at the month three primary efficacy end-point (ANOVA p < 0.05). Additional data in the presentation supported the activity of anecortave acetate in lowering IOP. [...] In terms of safety, the most frequently reported adverse events were related to the procedure and included eye pain, foreign body sensation, hyperemia and blurred vision, which were reported at an incidence of 5 percent to 15 percent. The most frequently reported events related to test article were conjunctival deposits and eye pain which were reported at an incidence of less than 5 percent
Source : Medical News Today
- La radiothÃ©rapie, abandonnÃ©e depuis longtemps en traitement de la DMLA, pourrait revenir au gout du jour, en complÃ©ment d’injections initiales d’anti-VEGF, si l’on en croit un communiquÃ© de presse rapportant une communication lors de la derniÃ¨re Macula Society. Ces donnÃ©es seront bien sÃ»r Ã confirmer lors de l’Ã©tude randomisÃ©e de phase III, dont le recrutement a dÃ©jÃ dÃ©butÃ© (CABERNET), ce d’autant que le traitement ne semble pas dÃ©nuÃ© d’effets indÃ©sirables… :
NeoVista Presents One Year Data on Novel Wet AMD Therapy at Macula Society
PALM BEACH, Fla., March 28 HSMN NewsFeed — NeoVista, Inc. released today to the eye community updated results from a one-year feasibility study of the companys novel epiretinal brachytherapy for the wet form of age-related macular degeneration AMD at the 31st Annual Macula Society Meeting in Palm Beach, Florida. The promising data from the study, which was initiated by NeoVista to test the efficacy and safety of their novel therapy when used in conjunction with AvastinÂ® bevacizumab, showed a marked improvement in mean visual acuity.
In the ongoing nonrandomized, multicenter feasibility study, 34 subjects with predominantly classic, minimally classic, or occult with no classic choroidal neovascularization CNV received a single 24 Gy treatment of NeoVistas epiretinal brachytherapy in combination with two injections of Avastin, one dose prior to or at the time of radiation delivery and another one month later, depending on which arm of the trial the patient was enrolled in.
After 12 months of follow-up on 33 of the trial participants, subjects had experienced a mean improvement in visual acuity of 10 letters using the Early Treatment Diabetic Retinopathy Study ETDRS test; 94 percent of patients lost fewer than 15 letters, 39 percent gained 15 or more letters, and 12 percent gained 30 or more letters. 76 percent of the patients in the study did not require additional injections of Avastin throughout the year.
Most adverse events were related to the vitrectomy procedure retinal tear, retinal detachment, subretinal hemorrhage, and vitreous hemorrhage. No events related to radiation toxicity have been reported to date.
Jeffrey S. Heier, MD, a retinal specialist, partner at Ophthalmic Consultants of Boston and a consultant for NeoVista, presented the one-year data obtained from trial participants mean age, 72 years who enrolled from June 2006 to April 2007 at two centers in Brazil and one in Mexico.
« As more data are collected and analyzed surrounding this one-time surgical procedure, were continuing to see the potential of the concomitant approach to treat wet AMD, » said Dr. Heier. « Unlike previous attempts with radiation therapy, NeoVista has developed a means of delivering targeted beta radiation to choroidal neovascular membranes with minimal penetration, resulting in little effect on the surrounding healthy tissue. »
In contrast to other forms of radiation therapy for wet AMD, NeoVistas approach delivers the peak dose of energy directly to the lesion without irreparably damaging the normal retinal vasculature. Utilizing strontium 90, the focused energy is delivered to a target area up to 3 mm in depth and up to 5.4 mm in diameter. Importantly for patients, the systemic exposure to radiation is minimal, as the effective dose to the entire body from NeoVistas epiretinal device is less than that from a typical chest x-ray.[…]
The CABERNET CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy trial is a multicenter, randomized, controlled study that will enroll 450 subjects at clinical centers worldwide. The study will evaluate the safety and efficacy of NeoVistas epiretinal beta radiation therapy delivered concomitantly with the FDA-approved antiangiogenic therapy LucentisÂ® ranibizumab versus Lucentis alone.
Source : Healthcare Sales & Marketing Network
VoilÃ donc quelques informations intÃ©ressantes prÃ©sentÃ©es pendant les « Subspecialty Days » :
- Un score afin de dÃ©terminer les cornÃ©es Ã risque d’ectasie aprÃ¨s chirurgie rÃ©fractive
- Association du laser femto-seconde et du « cross-linking » en traitement du kÃ©ratocÃ´ne
- Nouvelles mÃ©thodes diagnostiques du glaucome et Ã©tat des lieux des traitements en cours d’investigation :
Advances have been made recently in both structural and functional technologies for evaluating glaucoma. While many of these tools appear to perform better than earlier technologies, well-designed studies of their diagnostic abilities are still lacking, said Felipe A. Medeiros, MD, assistant professor of ophthalmology, University of California, San Diego.
- Les nouveaux OCT :
Spectral domain optical coherence tomography (SD-OCT), the latest generation of the technology, is a breakthrough because it has dramatically cut the time required to obtain images by eliminating the moving mirror that was a component of standard OCT, according to Cynthia Toth, MD.
In addition to being 50 times faster than conventional OCT, SD-OCT has improved resolution because of improved processing. Another benefit is decreased patient movement artifact, especially in pediatric patients.
- RÃ©sultats dÃ©cevants d’un implant sous-rÃ©tinien :
The visual acuity improvements from implantation of the Artificial Silicon Retina (ASR device, Optobionics Corp.) for treatment of vision loss associated with retinitis pigmentosa were « underwhelming, » with the 2-year data showing that only 8% of implanted eyes gained 10 letters or more, according to John Pollack, MD.
- DerniÃ¨res innovations pour la dÃ©livrance de mÃ©dicaments :
- Traitement de la rÃ©tinopathie des prÃ©maturÃ©s par anti-VEGF :
Anti-angiogenic therapy for aggressive posterior retinopathy of prematurity (ROP) may be a feasible therapy for these children with this form of ROP, which develops in profoundly immature neonates. The BLOCK-ROP study, which is slated to begin soon, will add to the limited knowledge of the safety and efficacy of an anti-vascular endothelial growth factor (VEGF) drug in treating posterior ROP, Anthony Capone Jr., MD, reported during Retina Subspecialty Day at the annual meeting of the American Academy of Ophthalmology.
- IntÃ©rÃªt du dorzolamide (topique) en traitement de l’oedÃ¨me maculaire :
- Confirmation de la supÃ©rioritÃ© de Lucentis sur la PDT Ã 2 ans (Ã©tude ANCHOR), de l’intÃ©rÃªt de l’OCT pour les dÃ©cisions de retraitement (Ã©tude PrONTO)… et le souhait de Genentech de travailler en coopÃ©ration aec les ophtalmologistes (!) :
Visual acuity endpoints in the ANCHOR Study showed that ranibizumab (Lucentis, Genentech) surpassed photodynamic therapy (PDT) with verteporfin, (Visudyne, Novartis Ophthalmics/QLT) for treating predominantly classic choroidal neovascularization lesions in age-related macular degeneration, reported Jeffrey Heier, MD, reported during Retina Subspecialty Day.
The results of the PrONTO Study, an exploratory open-label trial, indicated that intravitreal injection of ranibizumab (Lucentis, Genentech) produces rapid improvements in visual acuity and findings on optical coherence tomography (OCT) in patients treated for neovascular age-related macular degeneration, said Philip Rosenfeld, MD, PhD, during Retina Subspecialty Day.
In a special session held immediately after the close of the American Academy of Ophthalmology (AAO) Retina Subspecialty Day program, Susan Desmond-Hellmann, MD, MPH, president, product development, Genentech, implored the ophthalmology community to work in collaboration the company in the interest of achieving the common goal of better patient care.
- ActualitÃ©s sur les futurs traitement de la DMLA (VEGF-Trap et collyres) en dÃ©veloppement :
VEGF Trap (Regeneron Pharmaceuticals) has been seen in two studies (CLEAR-IT AMD 1 and CLEAR-IT AMD 2) to be safe, bioefficacious, and tolerated in the eyes of patients with neovascular age-related macular degeneration. The 2- and 4-mg doses demonstrated more bioactivity than lower doses evaluated, according to Quan Dong Nguyen, MD.
Topical therapy to treat posterior segment disease is possible despite the limitations of the blood-retinal barrier. The effective route of drug penetrance of topical therapy is either by the transcorneal route or by the transscleral/conjunctival route, said Baruch Kuppermann, MD, PhD, at Retina Subspecialty Day. He is chief of the Retina Service, Department of Ophthalmology, University of California, Irvine.
Vivement que nos collÃ¨gues soient de retour pour nous raconter plus en dÃ©tails tout cela !
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…