January 2018 Newsletter

January 25, 2018:

2017 in Review: Combination Treatments Fail in Many Trials

Pharmaceutical companies shut down development of once-promising candidates.

January 25, 2018:

Imprimis Responds to FDA Warning over Promotional Materials

The San Diego compounder said it will fully comply with regulators, and it expects no impact to its ophthalmic business.

January 25, 2018:

FDA Outlines Compounding Policy, Defines Drugs that are ‘Essentially Copies’

Agency says copies are those that share the same active ingredient, route of administration, dosage form, dosage strength, and excipients.

January 25, 2018:

Kala’s Dry Eye Candidate Meets Both Sign Endpoints, Misses One Symptom Endpoint in Phase III Studies

The company’s path forward may include another clinical trial or submitting current data in its NDA.

January 25, 2018:

Eyenovia Readies $30 Million IPO

The company’s piezo-print technology delivers topical micro-doses of drugs to the eye.

January 25, 2018:

Ohr’s Squalamine Combination Therapy Fails in Phase III Trial in Wet AMD

The New York-based company raised a total of $22 million in two recent public offerings.

January 25, 2018:

2017 in Review: RxSight Gains Approval for First Postoperatively Adjustable IOL

Company’s clinical investigators predict that this type of IOL will change the way premium cataract surgery is performed.

January 25, 2018:

2017 in Review: EDOF, Trifocal IOLs Expand the Presbyopia-Correcting Market

J&J Vision’s success with its Symfony lens has spurred other companies to enter the segment.

January 25, 2018:

2017 in Review: Luxturna Opens Door to Ophthalmic Gene Therapies

Developer Spark Therapeutics announced a price of $850 thousand per patient.

January 25, 2018:

2017 in Review: Hypersonic Vitrector Gains US Clearance, Early Praise from Surgeons

The probe provides 1.7 million pulses per minute and has a continually open port.

January 25, 2018:

2017 in Review: China Develops Own IOL Industry, Marks Several Milestones

Wuxi Vision Pro gained its first IOL approval from the China FDA.

January 25, 2018:

2017 in Review: Glaucoma, Cataract Surgeons Gain New MIGS Options

Glaukos projected sales growth of 35 to 40 percent for its iStent.

January 25, 2018:

2017 in Review: Glaucoma Drugs with New Modes of Action Earn US Approval

Bausch + Lomb’s Vyzulta and Aerie’s Rhopressa are the first to achieve the milestone since 1996.

January 25, 2018:

2017 in Review: New Treatment Options Fuel Physician Interest in Refractive Space

US surgeons can offer patients corneal inlays, SMILE, topo-guided LASIK, and cross-linking.

January 25, 2018:

2017 in Review: Growth in Dry Eye Procedure Segment Continues with Acquisitions, Novel Product Releases

Double-digit expansion is expected in this segment over the next five years.

January 25, 2018:

Market Report: Disposable Designs will Drive Ophthalmic Surgical Instruments Market to $1.64B by 2023

An aging population and greater access to health care will spur a 4 percent per year increase in eye surgeries.

January 25, 2018:

Major US Hospitals Plan to Create Generic Drug Company, NYT Reports

About 300 hospitals are on board so far, and the Department of Veterans Affairs is interested in participating.

January 25, 2018:

US FDA Rejects Santen’s Sirolimus for Uveitis, Asks for More Evidence of Efficacy

The company said it would work closely with the FDA to determine its next steps.

January 25, 2018:

Presbia CEO, Chairman Resign; Company Lays off 38 Percent of Workforce

Corneal inlay maker said its immediate focus is on gaining US approval of its Flexivue Microlens.

January 25, 2018:

Market Scope Weekly Polls

January 25, 2018:

January 2018 News Briefs

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