Posts tagged Amar Sawhney
Ocular, Regeneron in wet AMD collaboration

Ocular Therapeutix (NASDAQ:OCUL) has entered into a strategic collaboration, option and license agreement with Regeneron Pharmaceuticals (NASDAQ:REGN) to develop a sustained release formulation of the vascular endothelial growth factor (VEGF) trap, aflibercept, for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases.

Regeneron’s aflibercept has been approved by the FDA for certain indications under the brand name, EYLEA.

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Ocular Therapeutix gets complete response letter

Ocular Therapeutix (NASDAQ:OCUL) received a complete response letter (CRL) from the FDA about its NDA for DEXTENZA for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery.

Concerns raised by the FDA pertain to deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the company’s manufacturing facility. The FDA’s letter did not provide any details as to which manufacturing deficiencies remain open since the last response submitted by the company.

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Ocular Therapeutix second Phase 3 trial unsuccessful

Ocular Therapeutix’s (NASDAQ:OCUL) results from its second Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA, a bioresorbable intracanalicular depot, for the treatment of ocular itching associated with chronic allergic conjunctivitis failed to achieve statistical significance.

The single primary endpoint of the trial was the difference in the mean scores in ocular itching between the treatment group and the placebo comparator group at three time points seven days following insertion of the depots and was not achieved.

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Ocular Therapeutix to initiate Phase 3 program with OTX-TP

Ocular Therapeutix (NASDAQ:OCUL) has completed an end-of-Phase 2 review with the FDA for its sustained release travoprost product candidate, OTX-TP, for the treatment of glaucoma and ocular hypertension and intends to initiate the first of two Phase 3 clinical trials during the third quarter of 2016.

The FDA has stated that it agrees with the overall Phase 3 clinical development program proposed by Ocular in its briefing package submitted to the FDA.

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