New Introductions - Internationally

AMO Receives FDA Clearance For Fifth-Generation Femtosecond Laser

Advanced Medical Optics has received U.S. Food and Drug Administration clearance for its fifth-generation IntraLase femtosecond laser.

The fifth-generation model — called the iFS advanced femtosecond laser — is capable of creating a corneal flap in less than 10 seconds and features an inverted bevel-in side cut angle designed to enhance flap lift, increase postoperative flap adhesion and improve the biomechanical stability of the cornea. The laser is also capable of performing fully customized IntraLase-enabled keratoplasty, the release said.

Compared with prior models, the fifth-generation platform features a faster repetition rate, tighter spot separation, lower energy, a high-resolution digital video microscope and a newly designed user interface.

The model is also ergonomically designed to improve surgeon comfort.

FDA approves Brimonidine Tartrate- Timolol Maleate Fixed Dose Combination for Inadequately Controlled IOP

On October 30, the FDA approved brimonidine tartrate/timolol maleate 0.2%/0.5% topical ophthalmic solution to reduce intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy because of inadequately controlled IOP.

The recommended dosing for the alpha-adrenergic–receptor agonist plus beta-adrenergic–receptor inhibitor topical solution is 1 drop in the affected eye approximately every 12 hours; at least 5 minutes should elapse before and after administration of another topical product.

Use in children aged younger than 2 years is not recommended.

Approval of the combination product was based on data from 12-month pivotal trials, showing its use provided an additional decrease of 1 to 3 mm Hg in IOP vs brimonidine alone and an additional decrease of 1 to 2 mm Hg vs timolol alone during the first 7 hours after dosing.

Although the IOP-lowering effect of the combination product was slightly less than that of combination therapy with twice-daily timolol 0.5% solution and 3 times daily brimonidine 0.2% solution, it was associated with a decreased level of self-reported sleepiness in patients aged older than 40 years.

Adverse events reported in approximately 5% to 15% of patients using brimonidine/timolol solution included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritis, ocular burning, and stinging.

Allegretto Wave Eye-Q Granted Wavefront-Guided, Mixed Astigmatism Approval

The U.S. Food and Drug Administration has approved wavefront-guided and mixed astigmatism indications for WaveLight's Allegretto Wave Eye-Q system,

The FDA approved the Eye-Q system for reducing or eliminating up to 7 D of spherical equivalent of myopia or myopia with astigmatism, with up to –7 D of spherical component and up to 3 D of astigmatic component at the spectacle plane. The system is approved for use on patients at least 18 years of age who have a documented stable manifest refraction defined as less than or equal to 0.5 D of preoperative spherical equivalent shift over 1 year preop, according to the release.

Procedures performed using the system can also be done with a custom offset of –3 D to +1 D for sphere and –3 D to 0 D for cylinder, the release said.

For mixed astigmatism, the FDA approved the Eye-Q system for reducing or eliminating naturally occurring mixed astigmatism of up to 6 D at the spectacle plane in patients aged at least 21 years who have a documented stable manifest refraction defined as less than or equal to 0.5 D of preoperative spherical equivalent shift over 1 year preop.

Source: Ocular Surgery News, April 2007

Preservative free Travoprost

The Food and Drug Administration has approved a formulation of preservative-free travoprost for lowering IOP in patients with open-angle glaucoma or ocular hypertension.

Benzalkonium chloride (BAK) preservative in the original Travoprost formulation has been replaced by sofzia, an ionic-buffered preservative system that is more gentle on the ocular surface .

The approval was based on a double-masked, multi-center study of 690 adult patients with open-angle glaucoma or ocular hypertension. Travoprost with sofzia reduced IOP by an average of 8.5 mm Hg, demonstrating statistically equivalent IOP-lowering capacity to the Travoprost.

FDA Approval For Tonometer Diaton: Unique Tonometry Through Eyelid.

Diaton Tonometry is a unique approach to measuring intraocular pressure (IOP) through the eyelid - non-contact (no contact with the cornea), no anesthesia or sterilization is required.

BiCOM's pen-like, hand-held, portable device is perfect for measuring eye pressure and helps ophthalmologists and optometrists in diagnosis and prevention of blindness caused by glaucoma. This ophthalmic device is irreplaceable for mass glaucoma screenings.

"Diaton tonometer is a revolutionary device and signifies a new stage in Optometry and Ophthalmology!"
Tonometer Diaton is the perfect solution in the following cases when the use of other devices is problematic or impossible:
--mass prophylactic screening of patients;
--IOP control during clinical observation of glaucoma patients;
--ortoclinostatical probe, as an additional test to diagnose glaucoma and during select the adequate hypotensive therapy;
ophthalmotone monitoring (even at night time);
--IOP measuring during contact correction (lenses are not taken out)
--IOP measuring in immobilized patients;
--IOP measuring in children.
--On patients with the following conditions: chronic conjunctivitis, cornea pathology, including keratitis, keratotone, cornea dimness, after penetrating keratoplastics, keratoprosthesis, laser refractive correction of the eyesight, high degree of ametropy, astigmatism;
--On patients with medicinal allergies;
--Lasik/ PRK (recent clinical trials have proved that Diaton is the only device that can be used for IOP measurement right after these surgeries)

Bimatoprost + Timolol Fixed Combination granted EU approval

A combination treatment for glaucoma has been granted regulatory approval from European authorities, the drug's marketer said in a press release.

A combination of bimatoprost and timolol is indicated for the reduction of IOP in patients with open-angle glaucoma of ocular hypertension, which is insufficiently responsive to topical beta-blockers or prostaglandin analogues, Allergan said.

The fixed combination of bimatoprost 0.03% and timolol 0.5%, the glaucoma medication “offers powerful IOP-lowering efficacy comparable to the free combination of these two agents, and greater efficacy than monotherapy with either agent alone,” stated the release.

Bimatoprost – timolol fixed combination has been approved for once-daily dosing, which will help improve patient compliance. According to the release, the combination showed 40% less hyperemia than bimatoprost monotherapy in clinical trials.

FDA Approval for Expanded Indication of Bromfenac Ophthalmic Solution to Treat Pain Following Cataract Surgery

Pivotal Trial Results Demonstrated 75% of Patients with Pain Became Pain-Free within Two Days of Bromfenac

Bromfenac was previously approved in March 2005 for the Treatment of Ocular Inflammation following Cataract Surgery

Bromfenac ophthalmic solution 0.09% is a sterile, topical, non-steroidal anti-inflammatory solution for the treatment of ocular inflammation and pain following cataract surgery .

Two pivotal Phase III clinical studies of Bromfenac were completed in the United States. In these studies involving 527 patients, a statistically significant proportion of patients treated with Bromfenac achieved treatment success, defined as the complete absence of ocular inflammation compared to those patients who received placebo. This effect was evident in the Bromfenac group as early as day 3 following initiation of treatment. Furthermore, 75% of patients who experienced pain after cataract surgery were pain-free within two days of being treated with Bromfenac twice daily. In addition, 98% of patients experiencing pain after cataract surgery and receiving Bromfenac twice daily were pain-free within six days of treatment.

FDA Approves Star S4 IR Laser With Customvue To Treat High Myopia, Astigmatism

Advanced Medical Optics announced that the Visx Star S4 IR excimer laser has been approved by the U.S. Food and Drug Administration to treat high myopia and astigmatism with the CustomVue procedure.

The treatment is indicated for the reduction or elimination of myopia and astigmatism from –6 D to –11 D with up to –3 D of cylinder.

"The expansion of the CustomVue procedure for highly nearsighted and/or astigmatic individuals adds yet another level of safety, precision and personalization to the laser vision correction procedure,” said Sandy T. Feldman, MD, a contributor to the clinical trials. “In this group of individuals, the improved quality of vision is particularly significant. Almost all individuals who are eligible for LASIK surgery can now be treated with the personalized approach of the CustomVue procedure.”

The Visx Star S4 laser also features the first FDA-approved, fully automated, non-contact method of iris registration to align the correct CustomVue treatment with the cornea, according to company literature.

According to the press release, 98.3% of the patients who received CustomVue high myopia treatment were corrected to 20/40 or better at 6 months, and 84.3% were corrected to 20/20 or better without contact lenses or spectacles.

"I'm excited about having this option for my high myopic patients,” said Colman R. Kraff, MD, who also contributed to clinical trials. “The results from the clinical trial are outstanding. No high myopic results on any other laser platform, past or present, come close to the results that were achieved in this clinical trial.”

Nepafenac 0.1% Ophthalmic Suspension FDA Approved For Treatment Of Pain And Inflammation Associated With Cataract Surgery

Nepafenac suspension contains a novel prodrug that rapidly penetrates ocular tissues. It is the first ophthalmic non-steroidal anti-inflammatory prodrug to receive FDA approval.

The prodrug structure of Nepafenac suspension offers significant advantages to ophthalmic surgeons. It provides unique, target-specific activity that promotes penetration into the ocular tissues of most concern to ophthalmologists. This maximizes efficacy at the target sites of pain and inflammation following cataract surgery.

The approval is based on results of two multi-center, placebo-controlled studies involving over 680 patients. In these clinical trials, Nepafenac suspension was dosed three times per day, beginning one day prior to cataract surgery and continuing on the day of surgery and for 14 days postoperatively. Patients were evaluated at baseline and at one, three, seven and 14 days after surgery. Patients treated with Nepafenac suspension were found to have significantly less ocular pain and inflammation in the early postoperative period through the end of treatment.

In these studies, more than 80 percent of patients treated with Nepafenac suspension were pain free the day after surgery, compared to less than 50 percent in the placebo group .

Following two weeks of treatment with Nepafenac suspension, approximately 95 percent of patients were pain free, compared to 45 percent of patients in the placebo group. Additionally, 91 percent of patients treated with Nepafenac suspension had no clinically significant inflammation at Day 14, compared to approximately 47 percent of patients in the placebo group. In the studies, Nepafenac suspension was shown to be safe and well tolerated with no unexpected adverse events reported.

In controlled clinical studies, the most frequently reported ocular adverse events following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These events occurred in approximately five to 10 percent of patients. These events were similar to those reported with placebo and may be the consequence of the cataract surgery procedure.

Anacortave Acetate: FDA Approves Anacortave Acetate Suspension For Age Related Macular Degeneration (ARMD)

Steroids have been shown to increase the secretion of plasminogen activator inhibitor (PAI), which suppresses the breakdown of EC basement membrane and ECM. The potential complications include endophthalmitis, increased intraocular pressure, retinal detachment and cataract formation.

To avoid some of complications, angiostatic steroids, which are devoid of glucocorticoid properties, have been designed. Anecortave acetate is the prototype of this class of drugs.

Anacortave acetate suspension (15mg) has a positive impact on the vision of patients with AMD. This suspension is an investigational treatment for maintaining vision in patients with wet AMD. The drug is an angiostatic cortisene that inhibits the abnormal growth of blood vessels, a process scientifically known as angiogenesis. Angiostatic cortisenes are derived from the steroid class and engineered to remove chemical groups responsible for side effects, such as the development of cataracts and elevated intraocular pressure leading to glaucoma, while preserving potency against angiogenesis.

Anacortave acetate suspension is administered with a blunt-tipped, curved cannula to deliver the drug behind the eye without puncturing the eyeball. This method of delivery avoids the risk of intraocular infection and retinal detachment, the most common side effects associated with injecting therapeutic agents directly into the eye.

Anacortave acetate suspension requires less frequent dosing (once every six months) compared to some other investigational drugs, which are injected into the eye.

No clinically relevant side effects related to the medication or application procedure are reported.