Où l’on reparle de traitements que l’on aurait pu croire à l’abandon…
- En l’absence de résultats d’études cliniques depuis 2004, l’avenir de la iontophorèse, dont le principe consiste à faciliter la pénétration intrasclérale de molécules à l’aide d’un courant électrique, était incertain. Or, je l’ai déjà évoqué à plusieurs reprises (voir aussi une revue de la littérature en français sur le sujet dans le JFO de décembre 2007), un des défis pour les années à venir sera certainement d’améliorer les systèmes de délivrance de médicaments dans l’œil, afin par exemple de limiter le recours aux injections intra-vitréennes répétées : la iontophorèse pourrait constituer une des pistes.
EyeGate vient d’annoncer avoir finalisé un nouveau tour de financement, qui devrait donc permettre de débuter deux études de phase II (uvéite 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 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.
- Alors que l’Anecortave en traitement curatif de la DMLA exsudative ne trouvera probablement jamais sa place dans notre arsenal thérapeutique, Alcon a présenté au cours du dernier congrès annuel de l’American Glaucoma Society les résultats d’une étude du dépot juxta-scléral d’anecortave en traitement du glaucome chronique à angle ouvert : les deux doses testées (0.25ml ou 0.5ml soit 7.5 ou 15 mg), injectées au maximum tous les mois et demi, ont permis d’observer une réduction significative de la pression intra-oculaire à 3 mois, avec une bonne tolérance…
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 radiothérapie, abandonnée depuis longtemps en traitement de la DMLA, pourrait revenir au gout du jour, en complément d’injections initiales d’anti-VEGF, si l’on en croit un communiqué de presse rapportant une communication lors de la dernière Macula Society. Ces données seront bien sûr à confirmer lors de l’étude randomisée de phase III, dont le recrutement a déjà débuté (CABERNET), ce d’autant que le traitement ne semble pas dénué d’effets indésirables… :
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