Eyes on New Product Development: Preclinical Research

Abstract

In this issue, noteworthy is the approval of a new ophthalmic drug delivery system for the treatment of anterior segment inflammation. By my reckoning, this is only the 5th intraocular drug delivery system approved in the United States. Also of interest in the drug delivery area is the announcement of clinical results for an iontophoretic system. In retina, several firms made announcements of results of early stage trials, and one announced results of a pivotal phase 3 study. A new firm announced plans to develop a topical treatment for cataracts and presbyopia, and another company received a U.S. patent for a novel treatment for dry eye. Legal and regulatory actions continue to deal with issues of generic competition, compliance with clinical trial registration requirements, and issues related to substance abuse—even for nonopioids.

Ophthalmic Pharmaceuticals and Biologics

• Apellis announced 18-month data from its phase 2 “FILLY” trial of its APL-2 complement C3 inhibitor in patients with Geographic Atrophy (March 2018).

• Clearside Biomedical presented results from its “PEACHTREE” pivotal phase 3 clinical trial of suprachoroidal CLS-TA (triamcinolone acetonide) in patients with macular edema associated with noninfectious uveitis (March 2018).

• EyeGate Pharma announced top-line results from a phase 2b study of EGP-437 (dexamethasone) for the treatment of pain and inflammation in patients having undergone cataract surgery (February 2018).

• Genentech announced results of a phase 2 study examining its bispecific monoclonal antibody RG7716, which binds to and inactivates both VEGF-A and angiopoietin-2, in the treatment of patients with diabetic macular edema (February 2018).

• Icon Bioscience received U.S. FDA approval for Dexycu^® (dexamethasone intraocular suspension), to treat inflammation associated with cataract surgery (February 2018).

• RegeneRx received a U.S. patent for Thymosin beta 4 (Tβ4) for use in the treatment of dry eye syndrome (February 2018).

• Nightstar Therapeutics started its STAR phase 3 registration study of NSR_REP1, a gene therapy for choroideremia (March 2018).

• Santen presented results on a phase 1/2 study of intravitreal DE-122 (carotuximab) in the treatment of refractory wet age-related macular degeneration (February 2018).

• ViewPoint announced plans to develop VP1-001 through clinical proof-of-concept studies in patients with cataracts and presbyopia (March 2018).

Regulatory, Government, and Pharmaceutical Industry

• AbbVie is in U.S. federal court in Philadelphia regarding the Federal Trade Commission's request for compensation for the delay in generic versions of AndroGel^® testosterone, (February 2018).

• Allergan's patent protection on Restasis^® (cyclosporine ophthalmic emulsion) agreement with the Saint Regis Mohawk Tribe was struck down by the U.S. Patent Trial and Appeal Board (February 2018).

• A U.S. District Judge turned down Amgen's request for a 6-month extension on exclusivity of its Sensipar^® (cinacalet) (February 2018).

• Researchers at the University of Oxford developed an automated “watchdog” for tracking registration of clinical trials (February 2018).

• The U.S. FDA Commissioner Scott Gottlieb, M.D., said the agency is investigating potential misuse and abuse of gabapentinoids (February 2018). In a talk before a health insurance trade group, he also laid out flaws in how drugs are priced in the United States, highlighting hidden aspects of the system (“…Kabuki drug pricing constructs…”)¹

Footnotes

Author Disclosure Statement

The author consults for numerous ophthalmic pharmaceutical and medical device firms.

References

Novack

G.D

. What determines how much your patient pays for their medication in the United States?. Am. J. Ophthalmol., 167:48–51, 2016.