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Industry Pipeline
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Recent Premarket Approvals
¤Advanced Medical Optics received approval for the Visx Star S4 IR for the treatment of high myopia and astigmatism with the custom procedure.
¤Alcon received approval for the AcrySof Toric IOL for use in cataract patients with existing astigmatism.
Allergan’s Alphagan P 0.1%, designed to lower IOP in patients with open-angle glaucoma or ocular hypertension, has received U.S. marketing approval.
¤Miravant announced that the FDA has issued an approvable letter for SnET2 PDT, a light-activated drug designed to selectively destroy abnormal blood vessels and stabilize vision loss in patients with wet AMD.
¤STAAR Surgical Co.’s Visian ICL has received an approvable letter from the FDA.
¤Alcon received FDA approval for use of the Opti-Free RepleniSH Multipurpose Disinfecting Solution (MPDS) with all soft contact lenses including silicone hydrogel lenses
Awaiting Approval
Alcon announced that the FDA has issued an “approvable” letter for Extravan ophthalmic solution for the treatment of glaucoma. Extravan solution is a fixed combination of travoprost 0.004% and timolol 0.5%.
Alcon Inc. and Landec Corp.’s Port Punctum Occluder has completed clinical trials, and 510(k) has been filed.
U.S. regulators issued an “approvable” letter for a combination drug for the treatment of glaucoma, manufacturer Allergan announced. The drug, a combination of Lumigan (bimatoprost) and timolol, merges two already-approved drugs, the company noted.
Recent Applications
Alcon officials announced that the company is initiating two new phase 3 clinical trials for Retaane (anecortave acetate), which has received a “fast track” FDA designation as a therapy for choroidal neovascularization.
Bausch & Lomb announced that the FDA has accepted for review a new drug application for the company’s patented Retisert intravitreal implant for non-infectious uveitis affecting the posterior segment of the eye.
EyeKon received FDA approval to proceed to phase 2 on its Natural Clear Lens Series, a hydrophilic acrylic IOL.
The FDA has cleared GMP Companies Inc. to initiate a phase 3 clinical trial of its EyePass Glaucoma Implant. The trial is being conducted by GMP Vision Solutions Inc., a subsidiary of GMP.
ISTA Pharmaceuticals Inc. has submitted an application to conduct a phase 2b clinical trial for ecabet sodium, an eye drop for the treatment of dry eye syndrome.
OxiGene announced that it will enter phase 2 trial to investigate the efficiency of combretastatin A4 prodrug (CA4P), a vascular targeting agent for the treatment of macular degeneration.
Rayner has entered clinical trials for its C-flex IOL, an injectable hydrophilic acrylic lens designed to help reduce posterior capsular opacification. The lens is packaged with a single-piece, single-use injector and a sterile protective eye shield.
An RNA interference compound to treat age-related macular degeneration has begun a phase 1 trial, according to Sirna Therapeutics, the developer of the compound.
Phase 3
¤Genaera announced that Evizon (squalamine), an anti-angiogenic drug for the treatment of wet age-related macular degeneration, has entered the first of two planned phase 3 trials.
¤Indicates activity within the past 30 days.