Drug Therapy

FDA Approves Eylea- Alternative To Lucentis With Less Injections

The FDA approved injection Eylea (afilbercept), formerly called VEGF Trap-Eye, has been shown to be as effective as Lucentis for treatment of AMD, according to a 96-week study of 2,412 patients, conducted by Regeneron Pharmaceuticals. After a 3 month period of once a month dosing, Eylea can be given every 8 weeks, resulting in half as many injections as Lucentis. Sales have climbed considerably.

 

FDA Approves Digital Pill Technology

The FDA has approved a microchip that is placed inside a pill. It reacts with stomach acid and sends information to a patch the patient wears on their skin. The patch sends a signal to a smartphone, which contacts the doctor, letting him know that the patient has taken the medication. The doctor can know when to rev-up a patient’s medication based on the patient’s compliance.

 

SEE FULL STORY

Microneedles For Ocular Injection

Researchers at Georgia Institute of Technology have developed a microneedle that can deliver drugs to the eye in a minimally-invasive way. Instead of injecting with a hypodermic needle into the center of the eye, the microneedle would target the suprachoroidal space of the eye, which provides a natural passageway to the back of the eye. “That could open the door for the use of timed-release drugs that could reduce the need for frequent injections to treat chronic eye diseases.

 

New Drug "Cocktail" Shows Dramatic Improvements for AMD Treatment

A new anti-PDGF drug improves vision in AMD patients when combined with anti-VEGF therapy.

A press release from Ophthotech Corporation announced positive results from a clinical trial of their drug Fovista. This drug is directed against a platelet-derived growth factor (PDGF-B), which regulates cells associated with newly formed small blood vessels.

A New Anti-VEGF Drug?

Recent human clinical and pre-clinical research on the benefits of Integrin Peptide Therapy show positive results in blocking VEGF production at its source, thus inhibiting bleeding and fluid leakage in the eye.

 

SEE FULL STORY

FDA "Fast Tracks" Squalamine Eye Drops

A number of developments offer hope for future treatment of macular degeneration. The FDA granted fast track designation for squalamine eye drops for the treatment of wet AMD.

 

SEE FULL STORY

Avastin Warning

A statement issued on February 14th, by the FDA, warns patients and health professionals that a counterfeit version of Avastin 400 mg may have filtered down to some medical practices in the United States. The counterfeit version does not contain the medicine’s active ingredient, bevcizumab, which is needed for AMD therapy. The FDA informs doctors that the counterfeit version has a Roche label, and batch numbers and expiration dates inconsistent with Genetech’s approved format.

 

Eylea (VEGF Trap-eye) Approved by FDA

Eylea (VEGF Trap-eye) has been approved by the FDA.  The drug achieves the same results as Lucentis but after a monthly injection for three months it is then injected every two months.  Pricewise it is similar to Lucentis.  The potential of achieving the same efficacy with less frequent injections and monitoring offers a cost savings to consumers as well as a time saving benefit.

 

SEE FULL STORY

Avastin- Serious Eye Infections in Miami

The FDA issued an alert to health care professionals concerning the cancer drug Avastin. The drug has caused a cluster of serious eye infections in the Miami, Florida area. The problem was traced to a single pharmacy that repackaged the vials to have the appropriate dosage for intravitreal injections. Product sterility can be comprised during this process. More than a dozen people in Florida and Tennessee have developed severe eye infections after receiving the off-label treatment for macular degeneration.

VEGF Trap-Eye Delayed By FDA

The FDA delayed its approval of the VEGF Trap-Eye drug Eylea, despite its advisory panel’s recommendations, and extended the target date for completion of its review of the medicine to November 18th. There were questions on the company’s application regarding chemistry, manufacturing, controls and sales.

The drug, Eylea, manufactured by Regeneron Pharmaceuticals, would compete with Roche’s Lucentis. It only has to be injected every eight weeks, half as often as Lucentis.

Syndicate content