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Ocular diseases and the rise of Biologics in the field of Ophthalmology




Speaking at the American Academy of Optometry 2021 annual meeting in Boston, Anthony DeWilde, OD, FAAO, discussed biologics, which hold promise for the treatment of ophthalmic diseases. Original Post can be read here.


A wide range of articles cover the use of biologics in oncology. Apart from oncology, biologics have been successful in various therapeutic indications as listed in Annexure A.


Ocular diseases previously thought untreatable are being treated quite successfully using biologics. We explore some of the treatments that are helping patients suffering from ophthalmic diseases. According to Anthony DeWilde, "Biologics hold a lot of promise for treating ophthalmic diseases, this approach is providing improved outcomes with reduced side effects. The current downside is the high cost."


Treatment options for retinal diseases, such as neovascular age-related macular degeneration, diabetic retinopathy, and retinal vascular disorders, have markedly expanded following the development of anti-vascular endothelial growth factor intravitreal injection methods. However, because intravitreal treatment requires monthly or bimonthly repeat injections to achieve optimal efficacy, recent investigations have focused on extended drug delivery systems to lengthen the treatment intervals in the long term.

Dose escalation and increasing molecular weight of drugs, intravitreal implants and nanoparticles, hydrogels, combined systems, and port delivery systems are presently under preclinical and clinical investigations. In addition, less invasive techniques rather than intravitreal administration routes, such as topical, subconjunctival, suprachoroidal, subretinal, and trans-scleral, have been evaluated to reduce the treatment burden.


Despite the latest advancements in the field of ophthalmic pharmacology, enhancing drug efficacy with high ocular bioavailability while avoiding systemic and local adverse effects is quite challenging.


High-concentration formulations for ocular delivery have the potential to address current barriers to bioavailability. Viscosity reducing excipients that are safe for intravitreal administration can potentially reduce local adverse effects.


Qprotyn is committed to exploring the potential application of its HILOPRO™ technology that uses two GRAS excipients to create a paradigm shift in the ocular delivery of high-concentration protein biologics. If your company is focused on improving patient experience and you would like to discuss how Qprotyn's HILOPRO™ technology can help your team formulate high-concentration, low-viscosity, low-volume protein biologics like monoclonal antibodies for ocular administration, please write to us at upgrade@qprotyn.com



References

  1. Stone JH, Tuckwell K, Dimonaco S, et al. Trial of tocilizumab in giant cell arteritis. N Engl J Med 2017;377:317-28.

  2. Bonini S, Lambiase A, Rama P, et al., REPARO Study Group. Phase II randomized, double-masked, vehicle-controlled trial of recombinant human nerve growth factor for neurotrophic keratitis. Ophthalmology 2018;125:1332–43

  3. Pflugfelder SC, Massaro-Giordano M, Perez, VL, et al. Topical recombinant human nerve growth factor (cenergermin) for neurotrophic keratopathy: A multicenter randomized vehicle-controlled pivotal trial. Ophthalmology 2020;127:14–26.

  4. Kim HM, Woo SJ. Ocular Drug Delivery to the Retina: Current Innovations and Future Perspectives. Pharmaceutics. 2021;13(1):108. Published 2021 Jan 15. doi:10.3390/pharmaceutics13010108


Therapeutic Indications

Biologics Prescribed

Inflammatory bowel disease

Infliximab (Remicade®, Janssen Biotech Inc.); Adalimumab (Humira®, Abbvie Inc);

Ustekinumab (Stelara®, Janssen Biotech Inc.)

Psoriasis

Etanercept (Enbrel®, Amgen Inc.);

Guselkumab (Tremfya®, Janssen Biotech Inc.)

Ankylosing Spondylitis

Adalimumab (Humira®, Abbvie Inc); Etanercept (Enbrel®, Amgen Inc.); Infliximab (Remicade®, Janssen Biotech Inc.); Certolizumab pegol (Cimzia®, UCB Inc) Ixekizumab (Taltz®, Eli Lilly and Co) Erenumab (Aimovig®, Amgen)

Seckinumab (Cosentyx®, Novartis)

Migraine

Fremanezumab-vfrm (Ajovy®, Teva Pharmaceuticals)

Galcanezumab (Emgality®, Eli Lilly and Co)

Erenumab (Aimovig®, Amgen)

Giant cell arteritis

Tocilizumab (Actemra®, Genentech)

Neuropathic keratopathy

Cenegermin (Oxervate®, Dompé)

Graves' disease

​Teprotumumab (Tepezza®, Horizon Therapeutics)

Exudative age-related macular degeneration

Ranibizumab (Lucentis®, Genentech); Bevacizumab (Avastin®, Genentech);

Brolucizumab (Beovu®, Novartis)

Uveitis (non-infectious)

​Adalimumab (Humira®, Abbvie Inc)

Thyroid eye disease

​Teprotumumab (Tepezza®, Horizon Therapeutics)


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