Retinal Degeneration, Potential Market Opportunity & Clinical Pipeline Insights, 2019

Retinal degeneration is a debilitating condition with a major impact on daily life that affects everyday tasks like reading, watching TV, driving, etc. from performing basic functions to personal independent and mental health works. Retinal Degeneration is referred to as the deterioration of the retina caused by the progressive and eventual death of the retinal cells. It is the damage to photoreceptor cells of the retina, which malfunctions and distorts the received image. This is often described as a progressive disease in which the patient will suffer a continuous decline in vision.  Mutations occurred in the rhodopsin gene accounted for 25% to 30% of all cases of autosomal dominant retinitis pigmentosa (adRP) in some American countries. There are many mechanisms of retinal degeneration related to rhodopsin mutations or mutations involving or affecting the rhodopsin function. One of the mechanisms is rhodopsin overexpression, and another mechanism involves a mutation causing truncated rhodopsin that was found to affect rod function and increased the rate of photoreceptor degeneration.

Market Overview

The most common retinal degenerative diseases include Age-related Macular Degeneration (AMD), Retinitis Pigmentosa (RP), and Stargardt Disease. Due to the magnitude and severity of the problem, the new treatment strategies are being investigated to solve the problem including gene therapy, cell transplants, and optogenetics. Several of these approaches have entered the clinical phase of development. Precise retinal imaging and visual function testing are facilitating the more efficient clinical trial design. The Artificial replacement of dying photoreceptor cells by using retinal prostheses has received regulatory approval. Based on the disease stage of the individual, the therapeutic strategy should comprise photoreceptor cell rescue to delay or retinal replacement for vision restoration or arrest vision loss.

FDA approved Lucentis in June 2006 for treating the more advanced or "wet" form of macular degeneration. Macugen, which is developed by Eyetech Inc. and Pfizer, is administered into the eye through injections. The FDA approved a tiny, implantable device in July 2010 that works by magnifying images onto the retina to improve central vision, which is damaged by AMD. Regeneron Pharmaceuticals, Inc announced that a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection is approved by the U.S. FDA for treating wet age-related macular degeneration. The first drug therapy of Visudyne was approved for treating the wet form of macular degeneration.   The macular degeneration treatment for wet AMD is the Laser photocoagulation. Researchers are one step closer to develop eye drops to treat AMD. EyePoint Pharmaceuticals have received FDA Approval of YUTIQ™ (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis, in 2018. On Aug 2018, Dompe announced that the U.S FDA had approved OxervateTM (cenegermin-bkbj ophthalmic solution), a breakthrough therapy for neurotrophic keratitis, a rare and progressive eye disease that can lead to corneal scarring and vision loss. Some of the studies under phase III clinical trials include brolucizumab by Novartis, Ranibizumab by Hoffmann-La Roche for treating AMD, Squalamine lactate for treating age-related macular degeneration by Ohr pharmaceuticals, Conbercept by Chengdu Kanghong Biotech, SB11, Lucentis (ranibizumab) by Samsung Bioepis, Abicipar Pegol by Allergan.

High healthcare cost due to use of expensive new technologies and drugs, increased the cost of healthcare goods and services, growing geriatric population, high administrative cost, and physician fees are the major driver of the retinal degeneration market. Furthermore, a surge in the prevalence of eye-related disorders and a rise in the global geriatric population boost the market.  Additionally, strict mandates and growing off-label use are going to hinder the market growth over the years.

Key Developments

• Novartis AG is eying a possible 2019 launch for RTH258 (brolucizumab), an ophthalmology drug for the treatment of neovascular age-related macular degeneration.


• On Nov 2018, Bioeq has intended to file a BLA with US FDA for ranibizumab biosimilar for Wet age-related macular degeneration in the first half of 2019.

Segmentation

This pipeline analysis report segments the Retinal degeneration market based on therapies employed (monotherapy, combination therapy, and monotherapy/ combination therapy), RoA (intravitreal, oral, subretinal, topical, and subcutaneous), therapeutic modality (small molecule, stem cell, peptide, gene, monoclonal antibody, oligonucleotide, and biological), targets (beta-catenin, casein kinase 1 alpha, cyclooxygenase-2, and ornithine decarboxylase), MoA (beta-catenin inhibitor, casein kinase 1 alpha agonist, cyclooxygenase-2 inhibitor, immunosuppressant, and ornithine decarboxylase inhibitor), and recruitment status (active, not recruiting, completed, not yet recruiting, and recruiting).