Pendant ce temps là, signalons qu’une première prostaglandine non conservée vient d’être approuvée dans certains pays européens… et que l’European Glaucoma Society a dévoilé à l’occasion de son dernier congrès (début juin) la nouvelle édition des « Terminology and Guidelines for Glaucoma », disponible en téléchargement sur son site internet.
Source : Ophthalmology Times Europe (16 mai et 13 juin)
Il y a quelques jours, le laboratoire Allergan annonçait son souhait d’élargir les indications du bimatoprost à … la stimulation de la pousse des cils !
Ou comment transformer l’effet indésirable d’un médicament en produit cosmétique…
Contrairement à d’autres laboratoires en ce moment, cette stratégie permettra peut-être en outre à Allergan d’appréhender avec sérénité l’avenir et l’arrivée de médicaments génériques !
Cependant, des fabriquants de cosmétiques y avaient déjà pensé (voir par exemple : « Age Intervention Eyelash Conditioner » (Jan Marini Skin Research) ou « RevitaLash » (Athena Cosmetics Corporation), déjà sur le marché)… ce qui n’était justement pas du goût du laboratoire, si l’on en croit Ophthalmology Times Europe (janvier 2008)
Où l’on reparle de traitements que l’on aurait pu croire à l’abandon…
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 EyeGate® 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.
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
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 Avastin® 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 Lucentis® ranibizumab versus Lucentis alone.
Source : Healthcare Sales & Marketing Network
Pour ceux qui n’ont pas la chance d’être à la Nouvelle-Orleans pour le congrès de l’American Academy of Ophthalmology, Ophthalmology Times fait un compte-rendu quotidien des communications.
Voilà donc quelques informations intéressantes présentées pendant les « Subspecialty Days » :
Vivement que nos collègues soient de retour pour nous raconter plus en détails tout cela !
Alcon a publié il y a quelques jours un communiqué de presse (Source : OSN SuperSite), suite à un courrier de la FDA réclamant des données complémentaires pour approuver Retaane (acétate d’anécortave) en traitement de la DMLA exsudative :
HUENENBERG, Switzerland — 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 difficulté de recrutement, je me demande si le frein principal à poursuivre le développement n’est pas plutôt le fait qu’il n’ait malheureusement pas été possible de démontrer (statistiquement) la non-infériorité de Retaane par rapport à la photothérapie 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-être été intéressant 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 études sont en cours pour essayer de convertir ce traitement de la DMLA en anti-glaucomateux :
Retaane suspension remains commercially available in several countries outside of the United States.
Voilà ce que cela donne en Suisse d’après une publication récente… (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 résultats des anti-VEGF…
Basée sur les résultats des études OHTS (Ocular Hypertension Treatment Study) et EGPS (European Glaucoma Prevention Study), cette page internet permet de calculer le risque d’évoluer vers un glaucome à 5 ans en fonction de l’age, du cup/disc, de la PIO, de l’épaisseur cornéenne et des indices de champ visuel automatisé.
Il est également possible de faire les calculs hors ligne après enregistrement du document.
A quand une version pour PDA et/ou palm ?
Glaucome et dégénérescence maculaire liée à l’âge (DMLA) sont parmi les principales causes de cécité dans le monde (avec la cataracte et les complications du diabète). Hors, dépistés à temps, leurs conséquences pourraient être évitées, grâce notamment à l’arrivée récente de nouveaux traitements.
Trois structures itinérantes d’information et de dépistage sur le glaucome circulent simultanément depuis le 3 avril (jusqu’au 5 mai 2007) dans 25 villes de France, tandis qu’une structure d’information et dépistage de la DMLA prendra le relai du 11 mai au 25 juin (13 villes).
Pour plus de renseignements :
- Campagne de dépistage du glaucome : preservezvotrevue.fr
- Campagne de dépistage de la DMLA : association-dmla.com
Suite à la parution sur MedicalNewsToday d’un communiqué de presse concernant le résultat d’études précliniques d’un COLLYRE aux propriétés pour le moins étonnantes, j’ai enfin pris le temps d’aller voir le site internet de compagnie pharmaceutique responsable : Othera Pharmaceuticals…
Cette société fondée en 2002 développe en effet des traitements pour le moins … innovants !
Leur produit phare, OT-551, est un collyre indiqué en traitement de la DMLA, par sa capacité à limiter les dommages causées par les radicaux libres, et par ses propriétés antiangiogéniques, synergiques avec les traitements anti-VEGF actuels :
Dr. Mousa’s talk was presented at the Angiogenesis 2007 Conference in Key Biscayne, FL, hosted by the Bascom Palmer Eye Institute.
In his study, Dr. Mousa employed a well-known model of angiogenesis (the Chick Chorioallantoic Membrane or CAM model) wherein a blood vessel growth factor (i.e., vascular endothelial growth factor, or VEGF) is applied to a chick embryo to rapidly generate neovascularization, a hallmark of wet AMD. Dr. Mousa then studied the effect of either Lucentis or Avastin treatment alone, or in combination with Othera’s drug to inhibit the number of new blood vessels formed. The results from this model clearly demonstrate that when the Othera compound OT-551 is added to either Lucentis or Avastin treatment there is a synergistic effect versus either treatment alone.
Il n’en fallait pas plus pour lancer un essai clinique de phase II sur l’adjonction d’OT-551 au Lucentis en traitement de la DMLA exsudative, dont le recrutement devrait débuter dans quelques semaines ou mois aux USA. Le résultat escompté est d’augmenter le bénéfice en terme d’acuité visuelle, tout en permettant de diminuer le nombre d’injections intra-vitréennes (rien que ça !).
Une autre étude, concernant cette fois la DMLA atrophique, est déjà en cours de recrutement.
Mais ce n’est pas tout ! OT-551 permettrait également de ralentir l’opacification du cristallin ! Une étude de phase II est également en cours dans cette indication.
Je vous laisse imaginer le potentiel de ce traitement, topique rappelons-le, si les données précliniques se confirment en phase d’expérimentation clinique…
Non content de s’attaquer à deux causes majeures de malvoyance, Othera développe également un autre collyre, OT-730, nouveau béta-bloquant, qui serait dépourvu des effets indésirables systémiques bien connus de cette classe thérapeutique…
Trouvé sur le site de partage de vidéos Daily Motion, ce film simule ce que voit un conducteur dans différentes situation de malvoyance :
Les films sont également disponible séparément :
(Lire la suite…)
Ce site respecte les principes de la charte HONcode.
Vérifiez ici.
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