LenSx Lasers has received 510(k) clearance from the FDA for its LenSx femtosecond laser. The approval marks the first time a femtosecond platform has been cleared by the FDA for performing anterior capsulotomy during cataract surgery. Preliminary clinical evaluation demonstrated the ability of the laser platform to produce capsulotomies with diameters that were significantly more uniform and reproducible than manually created capsulorrhexes.

The FDA has deemed marketing materials touting Latisse, the newly released prescription eyelash thickener marketed by Allergan, as “misleading.” The FDA stated that Latisse ads omit and minimize risks associated with the product, such as redness and eye color changes. According to Reuters, the FDA has asked Allergan to immediately stop using the materials. Dow Jones has explained that the eye infection, bacterial keratitis, can cause blindness.

Sirion Therapeutics has received the US FDA has approved its NDA for Zirgan(TM) (ganciclovir ophthalmic gel) 0.15% as a treatment for acute herpetic keratitis (dendritic ulcers). The FDA approval was based on the results of clinical trials conducted by Laboratoires Thea of France in Europe, Asia and Africa that compared the efficacy and tolerability of Zirgan to acyclovir ophthalmic ointment 3% in patients with herpetic keratitis.

Staar Surgical Co expects a delay in approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its Visian Toric ICL, its implantable lens to treat myopia and astigmatism. The PMDA has, however, not sought any more clinical trials for Visian Toric ICL. The company’s Visian ICL products are, however, on a “very quick path” to approval in the country. Visian ICL (Implantable Collamer Lens) is used to treat myopia or nearsightedness.

An implantable contact lens that corrects vision in nearsighted patients is safe and does not have some of the side-effects of laser surgery. The researchers at the American Academy of Ophthalmology’s clinical journal Ophthalmology said that no patients opting for implantable contact lens have reported increased problems, such as glare halos, double vision, night vision or difficulty driving at night, all of which are the potential side-effects of Lasik surgery.