Eyes on New Product Development

Abstract

In this issue, several drug delivery firms are continuing to explore novel methods for delivery of drugs to the eye for treatment of glaucoma and uveitis. A novel dry eye treatment is in late stage development, and a “real-world” study was published. In retina, a novel gene therapy product is under development, as are 2 new chemical entities in clinical trials and a novel light system. In glaucoma, a new fixed-dose combination was submitted for regulatory approval, and a novel device is being developed. A new study suggests that orphan drug development takes longer than perceived.

Ophthalmic Pharmaceuticals and Biologics

Aerie Pharmaceuticals submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its fixed dose combination of netarsudil and latanoprost (Roclatan™) for the treatment of elevated intraocular pressure in patients with glaucoma and ocular hypertension (May 2018).

The dry eye assessment and management study group found insufficient evidence to support patients taking oral omega-3 supplements to reduce the signs and symptoms of dry eye (April 2018).¹

EyeGate Pharma is continuing to develop an ocular bandage gel using a cross-linked thiolated carboxymethyl hyaluronic acid platform. As well, the firm announced completion of patient enrollment for the pivotal phase 3 clinical study of its EGP-437 combination product for the treatment of noninfectious anterior uveitis (April 2018).

LayerBio received a small business grant from the National Eye Institute to develop a sustained-release travoprost formulation for the treatment of glaucoma (May 2018).

MeiraGTx Limited announced that the U.S. FDA granted fast track designation for adeno-associated virus-RPGR for the treatment of X-linked retinitis pigmentosa due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene (April 2018).

Novartis announced additional results from its HAWK and HARRIER trials of brolucizumab (RTH258) for the treatment of neovascular age-related macular degeneration (AMD, May 2018).

OcuMedic is developing a drug-eluting soft contact lens (May 2018).

Ocular Therapeutix began enrolling patients in a proof-of-concept clinical trial of a travoprost implant in the treatment of glaucoma (May 2018).

PanOptica started dosing in a phase 1/2 dose-ranging clinical trial of PAN-90806, a once-daily topical eye drop formulation of a small molecule with antivascular endothelial growth factor properties for the treatment of neovascular eye diseases (May 2018).

RegeneRx announced that the U.S. FDA has accepted all safety data from 2 phase 3 trials of dry eye treatment candidate RGN-259, but it is requiring an additional phase 3 trial to further demonstrate efficacy (April 2018).

Medical Devices

Camras Vision is starting a U.S. pilot study to evaluate the efficacy of the Camras device for the treatment of refractory glaucoma (April 2018).

Ivantis presented results from its COMPARE trial of the Hydrus microstent vs. 2 iStents as a stand-alone treatment for open-angle glaucoma (April 2018).

LumiThera Inc presented results from the LIGHTSITE I clinical trial for the treatment of dry AMD utilizing its LT-300 light delivery system (May 2018).

Regulatory, Government, and Pharmaceutical Industry

The U.S. FDA released a new draft guidance for the assessment of drug–drug interactions with therapeutic proteins (May 2018).²

The U.S. Supreme Court refused to take a case regarding ophthalmic drug drop size. Several firms including Allergan, Bausch + Lomb, Merck, and Pfizer requested the court to deny patients' suits regarding drop size and pricing (May 2018).

The U.S. FDA is seeking permanent injunctions to stop 2 stem cell clinics from marketing stem cell products without FDA approval, and for significant deviations from current good manufacturing practice requirements (May 2018).

Pfizer Inc said that U.S. regulators declined to approve the company's biosimilar of Roche's treatment for breast cancer, Herceptin^® (trastuzumab), and sought additional technical information (April 2018).

The U.S. Congress passed the “Right to Try” bill (H.R. 878/S 204). It is now pending presidential approval (May 2018). “Right to Try” is a movement to allow patients with terminal disease access to any possible treatment, above and beyond existing compassionate use regulation and programs.³

The Tufts Center for the Study of Drug Development reported that orphan drug development takes an average of 15.1 years from first patent filing to launch, 18% longer than standard drugs, which is 12.8 years (May 2018).

Footnotes

Author Disclosure Statement

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

References

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