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Ocular Therapeutix Resubmits NDA For Dextenza
Ocular Therapeutix has resubmitted a new drug application (NDA) to the FDA for Dextenza (dexamethasone insert) 0.4 mg for the treatment of ocular pain occurring after ophthalmic surgery, according to a press release. Ocular Therapeutix resubmitted the NDA in response to a complete response letter the company received from the FDA in July 2016, which identified items pertaining to deficiencies in the manufacturing process and controls. The company expects to receive an indication of the scope and timing of the FDA’s review of the company’s NDA resubmission within approximately 30 days.
Dextenza is administered by a physician as a bioresorbable intracanalicular insert and is designed for drug release to the ocular surface for up to 30 days. Following treatment, Dextenza resorbs and exits the nasolacrimal system without need for removal. The company has completed three phase 3 clinical trials with Dextenza for the treatment of postsurgical ocular inflammation and pain. Subject to the approval of the NDA for postsurgical ocular pain by the FDA, Ocular Therapeutix intends to submit an NDA supplement for Dextenza to broaden its label to include a postsurgical inflammation indication. The drug is also in phase 3 development for the treatment of ocular itching associated with allergic conjunctivitis.
EyeGate Announces Positive Top-Line Data From Pilot Trial of Ocular Bandage Gel
EyeGate Pharmaceuticals announced topline results from the first-in-human pilot trial of its EyeGate Ocular Bandage Gel (OBG), the acceleration of reepithelialization of large corneal epithelial defects in patients having undergone PRK.
The EyeGate OBG is a clear viscous hydrogel eye drop with a 0.75% concentration of CMHA-S hydrogel, capable of coating the ocular surface with little to no optical blur and designed to resist degradation under conditions present in the eye, the company stated in a news release. The prolonged residence time of the bandage on the ocular surface, it is thought, addresses the limitations of current non-cross-linked hyaluronic acid formulations.
The prospective, randomized, controlled study enrolled 39 subjects undergoing bilateral PRK surgery and aimed to assess the safety and performance of EyeGate OBG on its own or combined with a bandage contact lens (BCL) compared to the current standard of care, artificial tears and BCL. The primary endpoint of the study was complete wound closure by day 3.
The enrolled subjects were randomized into one of three study groups, with subjects receiving the same treatment in both eyes. The study demonstrated safety and tolerability of EyeGate OBG, with encouraging potential efficacy—5% of the subjects in arm 1 (OBG alone) achieved complete wound closure by day 3, compared to 53.8% of patients that received the standard of care. Additionally, the average wound surface area on day 1 (24 hours postsurgery) was 18.5 mm2 for patients in the OBG alone arm compared to 39.5mm2 in the BCL arm, a 53.3% improvement.
Based on these positive results, EyeGate said it plans to continue development with a double-masked, controlled trial evaluating EyeGate OBG monotherapy against BCL in the second quarter of this year.
“The results of this pilot trial are extremely exciting, as Eyegate OBG not only showed safety and tolerability results, but also demonstrated encouraging signs of potential efficacy, with 9 of 12 subjects achieving complete closure by day 3 and a significant reduction in average wound size just 24 hours after surgery,” Dan Durrie, MD, clinical professor and director of Refractive Surgery Services at the University of Kansas Medical Center and a principal investigator of study, said in a company news release. “These data suggest that the product has the potential to provide significant benefit in the treatment of various types of corneal epithelial defects.”
Novaliq Announces Positive Topline Results for Cyclasol
Novaliq announced positive phase 2 results for Cyclasol, a clear, preservative-free cyclosporine A solution, in 207 patients with moderate to severe dry eye disease. Cyclasol showed a consistent reduction in corneal fluorescein staining, the primary sign endpoint, with an early onset of action over the 4-month treatment period, according to a company news release.
This phase 2, randomized, double-masked, vehicle-controlled, multicenter US study consisted of four treatment groups, including two Cyclasol groups (0.05% and 0.1%), an open-label active control, and a placebo (vehicle control) group. Both Cyclasol groups showed a significant improvement in corneal staining compared with the vehicle over the 4-month treatment period. In particular, the central area of the cornea seems to benefit most, which is an important aspect for the visual function in dry eye patients, Novaliq reported. All treatment groups demonstrated improvement in symptoms, with Cyclasol showing improvements over vehicle in subgroups. Data further indicate an early onset of action by reduction in corneal and conjunctival staining in as few as 14 days. Both Cyclasol concentrations showed excellent safety, tolerability, and comfort, with 98% of the enrolled patients completing the treatment period. No serious adverse events were reported.
Sun Announces Positive Topline Results for Seciera
Sun Pharma announced successful phase 3 confirmatory clinical trial results for Seciera (cyclosporine A 0.09% ophthalmic solution) for the treatment of dry eye disease (DED), according to a company news release. Seciera is a patented, novel, proprietary nanomicellar formulation of cyclosporine A 0.09%. It is a clear, preservative-free, aqueous solution. Seciera is being developed by Ocular Technologies, a company recently acquired by Sun Pharma. Following this acquisition, Sun Pharma owns exclusive, worldwide rights to Seciera and is developing it for global markets, including the United States, Europe, Japan, and emerging markets.
In this 12-week, multicenter, randomized, double-masked, vehicle-controlled, phase 3 confirmatory study, 744 DED patients were treated either with Seciera or its vehicle. After 12 weeks of treatment, as compared to vehicle, Seciera showed statistically significant improvement in the primary endpoint, Schirmer score, a measurement of tear production (P .0001). The demonstration of efficacy by Seciera at 12 weeks is earlier than for other drugs approved for DED in the same class, Sun stated in the press release. Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle, with some showing an even earlier onset of action. Adverse events reported in the trial were mild to moderate and similar to those reported with other approved drugs in the category.