Here's a look at some of the latest news regarding ophthalmic drugs and therapies from the past week.
- Late last week, Valeant Pharmaceuticals International, Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The concerns raised by the FDA reportedly pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Fl. where some deficiencies were identified by the FDA. According to Valeant, the FDA's letter did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.
- Biopharmaceutical company Ocular Therapeutix, Inc. also recently received a CRL from the FDA, this one for their New Drug Application (NDA) for Dextenza™ (dexamethasone insert) 0.4 mg, for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery. Concerns raised by the FDA reportedly pertained to deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility. According to Ocular Therapeutix, there were no clinical issues identified in the CRL pertaining to efficacy or safety related to the post-surgical pain indication and company officials remain optimistic Dextenza will be approved once the open manufacturing items are closed.
- Imprimis Pharmaceuticals, Inc. announced positive results of a clinical study comparing the efficacy of its injected triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin (Tri-Moxi-Vanc) Dropless Therapy® formulation to drops commonly prescribed after cataract surgery now appear in the July issue of the Journal of Clinical Ophthalmology.
- Late-stage clinical biopharmaceutical company Clearside Biomedical, Inc. recently reported additional top-line data from its 46-patient Phase 2 clinical trial Tanzanite, which evaluated the treatment of macular edema associated with retinal vein occlusion (RVO) in treatment-naïve patients. The trial reportedly included an “active” arm of concomitant suprachoroidally administered Zuprata™, Clearside’s proprietary form of triamcinolone acetonide and intravitreally administered aflibercept (Eylea®, Regeneron Pharmaceuticals, Inc.) compared to an Eylea-alone “control” arm. According to Clearside, 78 percent of patients in the active arm of the Tanzanite trial did not require additional treatments during the three-month trial compared to 30 percent in the control arm (p=0.003).
- Parion Sciences has reportedly initiated a phase 2 clinical trial of P-321 Ophthalmic Solution in patients with Dry Eye Disease (DED). P-321 is a potent inhibitor of the epithelial sodium channels (ENaC) on the ocular surface, and is expected to restore the tear film on the ocular surface in those patients with dry eye disease.
- According to Inotek Pharmaceuticals Corporation, the United States Patent and Trademark Office has issued a composition of matter patent for the combination of the Company’s lead product candidate, trabodenoson, with a prostaglandin analog for the treatment of intraocular pressure (IOP) in patients with glaucoma. U.S. Patent number 9,370,530 (’530 patent) reportedly further strengthens the Company’s patent estate for trabodenoson and adds composition of matter intellectual property protection for the combination or kit treatment option until 2031.
- And pSivida Corp. recently announced its first Phase 3 trial of Medidur for the treatment of posterior uveitis continued to meet its primary endpoint (prevention of recurrence of disease) with high statistical significance through 12 month follow-up (p less than 0.00000001; intent to treat analysis). Posterior uveitis was reportedly much less likely to recur in eyes treated with a Medidur injection than those receiving a sham injection through 12 months (26.4% compared to 85.7%).