- FDA CLEARS LENSAR LASER SYSTEM FOR LENS FRAGMENTATION AND ANTERIOR CAPSULOTOMY IN CATARACT SURGERY. LensAR, Inc. has received 510(k) clearance from the FDA for use of the LensAR Laser System for anterior capsulotomy and lens fragmentation during cataract surgery. According to the company, the proprietary 3D-CSI (Confocal Structured Illumination) imaging and biometry system is being designed to image and analyze the anatomy across all grades of cataract to improve proficiency. The system has been used in more than 500 eyes outside the United States to date. For other indications, it is an investigational device limited by U.S. law to investigational use only. Go LensAR's
website for more information.
- OMEROS'S OMS302 ACHIEVES CO-PRIMARY ENDPOINTS IN PHASE 2B CLINICAL STUDY. Omeros Corporation recently
reported positive data from a Phase 2b clinical trial evaluating OMS302 in patients undergoing cataract surgery. OMS032, added to standard irrigation solution used during ophthalmological procedures, is the company's proprietary PharmacoSurgery product in development to maintain intra-operative mydriasis and reduce postoperative pain and irritation resulting from cataract and other lens replacement surgery. The multicenter, randomized, double-blind, vehicle-controlled Phase 2b trial included 221 patients treated with OMS302. Subjects demonstrated statistically significant (p<0.0001) and clinically meaningful maintenance of mydriasis throughout the cataract procedure. OMS302 was also significantly decreased (p=0.0418) pain in the early postoperative period and reduced the frequency of complaints of moderate and severe pain (2.5 times more complaints in the vehicle-treated patients). Additionally, the drug product was safe and well-tolerated in the study.
- WITH POSITIVE PHASE 2 RESULTS OF PF-04523655 FOR DME, QUARK AIMS TO INITIATE PHASE 2B STUDY. Quark Pharmaceuticals, Inc. has received results from a prospective, randomized Phase 2 trial, the DEGAS study, which evaluated the safety and efficacy of PF=04523655 (RTP801I-14) in patients with diabetic macular edema (DME). The study was designed with a primary endpoint of mean visual acuity improvements over baseline at 24 months and 184 patients were randomly assigned to four treatment groups; three dose levels of PF-04523655 (RTP801I-14) (0.4 mg, 1 mg and 3mg) or laser. Interim results at 12 months showed that there were no drug-related Serious Adverse Events (SAEs) and following 12 months of treatment with PF-04523655 (RTP801I-14), a dose-dependent improvement in visual acuity was observed with the best results achieved at the 3-mg dose level. The study was terminated at 12 months based upon the interim analysis suggesting that higher doses would be necessary to produce a therapeutic effect sufficiently superior to the current standard of care to benefit patients over the long term, given emerging new therapeutic modalities. Based on these results, and in view of a dose-related effect on vision, Quark and Pfizer have mutually agreed that a Phase 2b study will be conducted by Quark at its own expense under a protocol mutually agreed upon by Quark and Pfizer, where Quark will test higher doses of PF-04523655 (RTP801I-14) and determine the optimal dose for pivotal Phase 3 studies. The two companies have also agreed to amend their existing agreement to enable Quark to conduct the Phase 2b study. For more information, visit
www.quarkpharma.com.
- POSITIVE PHASE ½ RESULTS FOR ISV-303 FOR THE REDUCTION OF PAIN AND INFLAMMATION AFTER CATARACT SURGERY. InSite Vision Incorporated has announced top-line results from its recently completed Phase ½ clinical trial of its topical anti-inflammatory product, ISV-303, intended to reduce the pain and inflammation associated with ocular surgery. The randomized, four-arm study compared once- and twice-daily doses of ISV-303 versus Xibrom and DuraSite (vehicle), each administered twice daily. (ISV-303 combines a lower dose [0.075%] of the non-steroidal anti-inflammatory [NSAID] bromfenac [Bromday/Xibrom (bromfenac ophthalmic solution)] 0.09%, marketed by ISTA Pharmaceuticals) with InSite Vision's proprietary DuraSite drug delivery technology. The Phase ½ clinical trial enrolled 169 patients undergoing cataract surgery. The primary endpoint of the study was the absence of cells in the anterior chamber of the eye at day 15 following surgery. According to InSite, once-daily ISV-303 achieved statistically significant superiority compared to vehicle (53.3% vs. 19.0%, p=0.0016) for the primary endpoint. Click
here for more study results. InSite also plans to conduct a Phase 2 pharmacokinetic study of once-daily ISV-303 against ISTA Pharmaceutical's currently marketed once-daily NSAID, Bromday.
- R-TECH UENO AND SUCAMPO ENTER LICENSE AGREEMENT FOR UNOPROSTONE. After the termination of a license agreement with Novartis Pharma AG last year, R-Tech Ueno, Ltd. sought a new licensee to maximize business profit from unoprostone (Rescula), and has recently signed a new license agreement with Sucampo Manufacturing and Research AG (SMR), a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc. Under the terms of the agreement, SMR holds exclusive rights to develop, use, make, have made, export, commercialize, promote, offer for sale and sell unoprostone in SMR Territory for its approved indication, the treatment of glaucoma and ocular hypertension. Also under this agreement, SMR has gained the right to develop the drug for additional ophthalmic indications as well as rights to all associated patents and other intellectual property associated with unoprostone in SMR territory. R-Tech Ueno receives an upfront payment of $3 million from SMR upon execution of the agreement and will receive additional milestone payments based on the achievement of specified development and commercialization goals. Read more
here.
- CORRECTION: WAVETEC LAUNCHES ORANGE WAVEFRONT ABERROMETER UPGRADE. Last week, we incorrectly stated that WaveTec Vision will charge practices a flat rate of $30,000 per month for unlimited use of its intraoperative wavefront aberrometer technology. The correct amount is $3,000. Below is the full story with the correction:
WaveTec Vision has launched its latest system upgrade and has introduced an unlimited-use pricing model for the ORange intraoperative wavefront aberrometer. The company's v2.6 software for ORange includes more than 20 new functions, with special focus on accuracy updates and data sharing. According to WaveTec, improvements to the post-refractive IOL power calculation algorithm and a warning to the user when a measurement is not consistent with the preoperative biometry of the patient are some of the new features. Additionally, moving away from a per-use cost basis, practices will now be charged a flat rate of $3,000 per month for unlimited use of the intraoperative wavefront aberrometer technology. Learn more at
www.wavetecvision.com.
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