- QLT SHARES POSITIVE PRELIMINARY RESULTS FROM PHASE 1b TRIAL OF QLT091001 IN RP. QLT Inc. recently
announced positive preliminary results from its international multi-center Phase 1b proof-of-concept clinical trial of QLT091001 for the treatment of retinitis pigmentosa (RP) due to inherited genetic mutations in retinal pigment epithelium protein 65 (RPE65) or lecithin:retinol acyltransferase (LRAT, also known as early-onset RP). In the open-label, multi-center Phase 1b clinical study, 17 subjects (ranging in age from 6 to 55 years, mean 29 years) with either RPE65 (12 subjects) or LRAT (5 subjects) mutations received a 40 mg/m²/day dose of QLT091001 once daily for seven days with post-treatment follow-up at 7, 14 and 30 days. The study showed rapid, statistically significant and clinically meaningful changes in visual fields from baseline values, as well as improvements in visual acuity. After a single 7-day course of treatment with QLT091001, the average retinal areas from baseline showed statistically significant improvement of 23% at day 30 (p=0.07) in the evaluable subjects meeting Goldmann Visual Fields test criteria (n=14 subset).
- PHASE III STUDY OF EGP-437 FOR ANTERIOR UVEITIS INITIATED. EyeGate Pharma has enrolled the first patient in a milestone Phase III pivotal study of its lead product EGP-437 (a late-stage asset with multiple indications for inflammatory ocular indications), for the treatment of anterior uveitis. EyeGate says the randomized double-masked positive-controlled non-inferiority study will enroll up to 200 subjects at more than 20 U.S. sites to assess the effectiveness of EGP-437 in comparison to topically applied prednisolone acetate eye drops. The drug will be administered using the company's non-invasive iontophoretic drug delivery technology, the EyeGate II Drug Delivery System. The Phase II study results, published in the January 2012 issue of
Ophthalmology, revealed that roughly two-thirds of the patients reached an anterior chamber cell score of zero within 28 days, after only receiving on iontophoresis treatment. No changes in IOP or signs of cataract formation were detected. Click
here for additional information.
- ACUVUE 1-DAY MOIST BRAND CONTACT LENSES FOR ASTIGMATISM LAUNCHED. At this year's Southeastern Council of Optometry (SECO) International Congress, Vistakon Division of Johnson & Johnson Vision Care, Inc. announced the U.S. launch of 1-Day Acuvue Moist Brand Contact Lenses for Astigmatism, a new daily disposable soft toric contact lens for individuals with astigmatism. In addition to the health and convenience benefits of wearing a fresh contact lens every day, 1-Day Acuvue Moist for Astigmatism features a proprietary Blink Stabilized Design that helps keep the lens in place and quickly realign it if it rotates out of position, providing wearers with consistent, all-day vision. According to Vistakon, 1-Day Acuvue Moist for Astigmatism are made using Lacreon Technology, a unique process that permanently embeds a water holding ingredient, similar to that found in natural tears, into the proven etafilcon A material of the 1-Day Acuvue Brand. Visit
www.jnjvisioncare.com for additional information.
- ADDITIONAL RANGE OF POWERS ADDED TO B+L'S PUREVISION 2 HD FOR ASTIGMATISM LINE OF CLS. Bausch + Lomb is expanding the range of powers to its PureVision2 for Astigmatism line of contact lenses. The line is currently available in plano to –6.00D (.25D steps) sphere power, and –0.75, –1.25D, –1.75 cylinder powers and the expanded range will be launched in two waves. According to Bausch + Lomb, the first wave, launched on March 1, 2012, extends the sphere powers offered to plano to –9.00D (.50D steps above –6.00D), and cylinder powers of –0.75D, –1.25D, –1.75D and –2.25D in 10° increments around the clock. The second wave, planned for May 1, will add plus powers up to +6.00D (.25D steps) to the range. The entire range will be available in the same four cylinder powers, –0.75D, –1.25D, –1.75D, to –2.25D in 10° increments around the clock. For more, click
- OCuSOFT LENS CARE SYSTEM NOW AVAILABLE. OCuSOFT, Inc. has entered into a joint venture agreement with Essentia Pharma, LLC to introduce and market the OCuSOFT Lens Care System for soft contact lenses. OCuSOFT says that its cleaning system's convenient 3-in-1 system deep cleans, stores and disinfects with the efficacy of 3% hydrogen peroxide while ensuring comfort with a lubricating agent and no added preservatives. Special discount pricing is available to doctors for dispensing from their office; however, patients may order direct at
- POSITIVE OUTCOME ANNOUNCED TO THE EUROPEAN DECENTRALIZED PROCEDURE FOR APPROVAL OF ILUVIEN FOR THE TREATMENT OF CHRONIC DME. Following the issuance of the Final Assessment Report from the Reference Member State (RMS), the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) and the agreement of all the Concerned Member States (CMS) that Iluvien is approvable, Alimera Sciences, Inc. recently reported the positive outcome of the Decentralized Procedure (DCP) for Iluvien in Europe. The regulatory process will now enter the national phase of the DCP in which the RMS and each CMS grants its national license. Iluvien will be indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Read more
- BIOPTIGEN CLEARED TO MARKET ENVISU SDOIS IN CANADA. Bioptigen Inc. has received a medical device license from Health Canada to begin marketing its hand-held Enisu SDOIS c2200 and C2300 ophthalmic imaging systems for patient use. The company's Envisu C series SDOIS imaging systems use low-power, near-infrared light to generate real-time, high-resolution, depth-resolved images of eye structures, equipping researchers and clinicians to explore new avenues of understanding in eye disease progression, detection and treatment. Availability of Envisu systems in the United States for patient use is dependent on review and market clearance by the FDA. Get additional information at
- SANTEN TO LAUNCH NEW OTC EYE DROP IN JAPAN. On March 10, 2012, Santen Pharmaceutical Co., Ltd. will launch its new OTC eye drop, Sante Medical Guard, a sister product of Sante Medical 10, in Japan. The new product contains maximum therapeutic concentrations of flavin adenine dinucleotide sodium (active vitamin B2) to enhance corneal tissue regeneration and promote healing, and chondroitin sulfate sodium to moisturize and protect the cornea. Santen says Sante Medical Guard protects against serious eye conditions and provides relief for symptoms of eye inflammation such as soreness, pain and dry eye irritation. More information is available at