Over the past week, news about the FDA has been flooding the inboxes of ophthalmology watchers.
The most notable news came Shire plc. The regulatory agency requested that Shire conduct an additional clinical trial as part of a complete response letter for the company’s NDA for lifitegrast, a potential treatment for dry eye disease in adults.
Such news typically can be devastating, but the setback for Shire should be minor. Shire recently completed OPUS-3, a Phase 3 study of lifitegrast. If the results are positive they should push the company toward a potential launch in 2016.
Company officials declined to comment, pointing to the issued press release. Media reports suggest the news could threaten Shire’s bid for publicly traded Baxalta, but the setback won’t diminish its interest in ophthalmology.
Other news regarding the FDA originated from companies:
Avedro Inc. resubmitted its NDA for riboflavin ophthalmic solution/KXL System. Avedro anticipates an application action date (PDUFA) in April 2016. If approved, the NDA would be the first FDA approved therapeutic treatment for progressive keratoconus and corneal ectasia following refractive surgery.
This has been a particularly long and winding path for the privately held Avedro. In February, an advisory panel of the FDA voted to approve the NDA, but a month later the FDA asked more questions delaying the anticipated approval of the device.
Keratoconus is a potentially blinding disease, for which no therapeutic treatment is available in the U.S.
Publicly held Inotek Pharmaceuticals announced that it has begun dosing patients in MATRx-1, its pivotal Phase 3 trial of trabodenoson for the treatment of glaucoma. Trabodenoson is Inotek’s lead clinical candidate, an adenosine mimetic under investigation for reduction of intraocular pressure.
The company says MATRx-1 is a randomized, double-masked, placebo-controlled trial involving 335 patients diagnosed with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The trial will be used to assess the efficacy, safety and tolerability of trabodenoson over three months of treatment. The primary endpoint will be the reduction of intraocular pressure (IOP) as compared to the placebo treatment arm.
Eleven Biotherapeutics announced the completion of patient enrollment in its first pivotal, Phase 3 clinical study of isunakinra (EBI-005) in patients with moderate to severe allergic conjunctivitis. Isunakinra, a topical, novel interleukin-1 (IL-1) receptor blocker, is Eleven’s lead drug candidate in development for the treatment of moderate to severe allergic conjunctivitis. In a release, CEO and President Abbie Celniker said the company remains on target for a Q1 2016 announcement of top-line results.
Publicly traded Ampio Pharmaceuticals announced that it met with the Division of the Transplant and Ophthalmology Products of the FDA to discuss the results of the OptimEyes clinical trial of its Optina, ultra-low dose form of danazol. Optina delays the relentless progression to blindness in patients with Diabetic Macula Edema. (DME)
Per the meeting, Ampio will perform a confirmatory study on patients with DME who are refractory to the currently available drugs. The study will include roughly 80 patients. Half will be given Optina while the other half is given a placebo.
If successful in the trial, Optina could qualify as a rescue medicine.